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Hydrocortisone for Term Hypotension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01954056
Recruitment Status : Completed
First Posted : October 1, 2013
Results First Posted : April 2, 2019
Last Update Posted : April 2, 2019
Sponsor:
Collaborators:
National Center for Research Resources (NCRR)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
NICHD Neonatal Research Network

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Infant, Newborn, Diseases
Cardiovascular Insufficiency
Interventions Drug: Hydrocortisone
Drug: Placebo
Enrollment 12
Recruitment Details Infants < 48 hours of age and born at ≥ 34 weeks gestational age were screened for the study between June 2014 and July 2015 at the 16 NRN Clinical Centers. Those who were intubated and on mechanical ventilation for at least 2 hours within the first 72 hours were considered for the study.
Pre-assignment Details  
Arm/Group Title Hydrocortisone Placebo
Hide Arm/Group Description

hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line

Hydrocortisone: • 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line).

1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose

Saline placebo

Placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume)

1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose

Period Title: Birth to 60 Days of Life
Started 6 6
Completed 6 6
Not Completed 0 0
Period Title: Birth to 22-26 Mos. Corrected GA
Started 6 6
Completed 5 6
Not Completed 1 0
Reason Not Completed
Lost to Follow-up             1             0
Arm/Group Title Hydrocortisone Placebo Total
Hide Arm/Group Description

Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line).

1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose

Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume)

1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose

Total of all reporting groups
Overall Number of Baseline Participants 6 6 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Weeks
Number Analyzed 6 participants 6 participants 12 participants
37.5  (2.2) 39.4  (1.8) 38.4  (2.2)
[1]
Measure Description: Age refers to the infant and is measured as gestational age in weeks.
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
Male
4
  66.7%
2
  33.3%
6
  50.0%
Female
2
  33.3%
4
  66.7%
6
  50.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
Hispanic or Latino
1
  16.7%
1
  16.7%
2
  16.7%
Not Hispanic or Latino
3
  50.0%
5
  83.3%
8
  66.7%
Unknown or Not Reported
2
  33.3%
0
   0.0%
2
  16.7%
Maternal Race  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
Black
3
  50.0%
2
  33.3%
5
  41.7%
White
3
  50.0%
2
  33.3%
5
  41.7%
More than one race
0
   0.0%
1
  16.7%
1
   8.3%
Unknown or Not Reported
0
   0.0%
1
  16.7%
1
   8.3%
Maternal Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 12 participants
32.2  (7.6) 26.7  (9.5) 29.4  (8.7)
Birth weight  
Mean (Standard Deviation)
Unit of measure:  Grams
Number Analyzed 6 participants 6 participants 12 participants
3415  (669.3) 3120.3  (541) 3267.7  (600.3)
Length  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 6 participants 6 participants 12 participants
50.1  (2.3) 49.8  (1.5) 49.9  (1.9)
Head circumference  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 6 participants 6 participants 12 participants
34.4  (2) 34.5  (3.5) 34.5  (2.7)
Apgar score less than 3 at 1 minute   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
No
2
  33.3%
4
  66.7%
6
  50.0%
Yes
4
  66.7%
2
  33.3%
6
  50.0%
[1]
Measure Description: The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. Total Apgar scores range from 0 to 10. This measure is calculated at 1 minute after birth as Yes if total Apgar is less than 3. No, otherwise.
Apgar score less than 3 at 5 minutes   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
No
5
  83.3%
6
 100.0%
11
  91.7%
Yes
1
  16.7%
0
   0.0%
1
   8.3%
[1]
Measure Description: The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. Total Apgar scores range from 0 to 10. This measure is calculated at 5 minutes after birth as Yes if total Apgar is less than 3. No, otherwise.
Apgar score less than 3 at 10 minutes   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
No
3
  50.0%
3
  50.0%
6
  50.0%
Yes
0
   0.0%
0
   0.0%
0
   0.0%
Unknown
3
  50.0%
3
  50.0%
6
  50.0%
[1]
Measure Description: The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. Total Apgar scores range from 0 to 10. This measure is calculated at 10 minutes after birth as Yes if total Apgar is less than 3. No, otherwise.
Infant Outborn  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
No
4
  66.7%
2
  33.3%
6
  50.0%
Yes
2
  33.3%
4
  66.7%
6
  50.0%
Oxygen   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
Yes
6
 100.0%
6
 100.0%
12
 100.0%
No
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Description: Collected during Resuscitation at Delivery
Bagging and Mask   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
No
1
  16.7%
2
  33.3%
3
  25.0%
Yes
5
  83.3%
4
  66.7%
9
  75.0%
[1]
Measure Description: Collected during Resuscitation at Delivery
Chest Compression   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
No
5
  83.3%
5
  83.3%
10
  83.3%
Yes
1
  16.7%
1
  16.7%
2
  16.7%
[1]
Measure Description: Collected during Resuscitation at Delivery
Intubation   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
No
4
  66.7%
1
  16.7%
5
  41.7%
Yes
2
  33.3%
5
  83.3%
7
  58.3%
[1]
Measure Description: Collected during Resuscitation at Delivery
Medications or volume expanders   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
No
5
  83.3%
3
  50.0%
8
  66.7%
Yes
1
  16.7%
3
  50.0%
4
  33.3%
[1]
Measure Description: Collected during Resuscitation at Delivery
Maternal marital Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
Married
1
  16.7%
1
  16.7%
2
  16.7%
Single
5
  83.3%
5
  83.3%
10
  83.3%
Maternal gravida   [1] 
Median (Full Range)
Unit of measure:  Number of pregnancies
Number Analyzed 6 participants 6 participants 12 participants
2.5
(1 to 6)
1
(1 to 7)
2
(1 to 7)
[1]
Measure Description: The number of confirmed pregnancies.
Maternal parity   [1] 
Median (Full Range)
Unit of measure:  Number of successful pregnancies
Number Analyzed 6 participants 6 participants 12 participants
2.5
(1 to 4)
1
(1 to 4)
2
(1 to 4)
[1]
Measure Description: The number of pregnancies reaching 20 weeks and 0 days of gestation or beyond, regardless of the number of fetuses or outcomes, including this delivery.
Maternal multiple birth  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
No
6
 100.0%
6
 100.0%
12
 100.0%
Yes
0
   0.0%
0
   0.0%
0
   0.0%
Maternal prenatal care  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
No
2
  33.3%
1
  16.7%
3
  25.0%
Yes
4
  66.7%
5
  83.3%
9
  75.0%
Maternal antenatal steroids  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
No
6
 100.0%
6
 100.0%
12
 100.0%
Yes
0
   0.0%
0
   0.0%
0
   0.0%
Maternal documented chorioamnionitis  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
No
5
  83.3%
6
 100.0%
11
  91.7%
Yes
1
  16.7%
0
   0.0%
1
   8.3%
Placental pathology performed  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
No
1
  16.7%
1
  16.7%
2
  16.7%
Yes
2
  33.3%
3
  50.0%
5
  41.7%
Unknown
3
  50.0%
2
  33.3%
5
  41.7%
Final mode of delivery  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
Vaginal vertex
3
  50.0%
2
  33.3%
5
  41.7%
Cesarean section
3
  50.0%
3
  50.0%
6
  50.0%
Unknown
0
   0.0%
1
  16.7%
1
   8.3%
1.Primary Outcome
Title Death
Hide Description This is measured as Yes if an infant died between birth and 22-26 months corrected gestational age; Otherwise, No.
Time Frame Birth to 22-26 months corrected gestational age
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.
Arm/Group Title Hydrocortisone Placebo
Hide Arm/Group Description:

Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line).

1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose

Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume)

1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose

Overall Number of Participants Analyzed 6 6
Measure Type: Count of Participants
Unit of Measure: Participants
No
6
 100.0%
6
 100.0%
Yes
0
   0.0%
0
   0.0%
2.Primary Outcome
Title Number of Participants With Neurodevelopmental Impairment
Hide Description This is measured as Yes if an any hearing impairment or visual impairment is noted, if non-normal gross motor function level is noted, any seizures have been noted, or if the cognitive, language, or motor scores of the Bayley III score are more than 1 standard deviation below the average; Otherwise, No.
Time Frame Birth to 22-26 months corrected gestational age
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.
Arm/Group Title Hydrocortisone Placebo
Hide Arm/Group Description:

Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line).

1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose

Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume)

1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose

Overall Number of Participants Analyzed 6 6
Measure Type: Count of Participants
Unit of Measure: Participants
Yes
6
 100.0%
6
 100.0%
No
0
   0.0%
0
   0.0%
3.Primary Outcome
Title Number of Participants With Death or Neurodevelopmental Impairment
Hide Description A composite outcome that measures the occurrence of death or neurodevelomental impairment between birth and 22-26 months corrected gestational age.
Time Frame Birth to 22-26 months corrected gestational age
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.
Arm/Group Title Hydrocortisone Placebo
Hide Arm/Group Description:

Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line).

1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose

Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume)

1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose

Overall Number of Participants Analyzed 6 6
Measure Type: Count of Participants
Unit of Measure: Participants
Yes
6
 100.0%
6
 100.0%
No
0
   0.0%
0
   0.0%
4.Secondary Outcome
Title Duration of Mechanical Ventilation
Hide Description This is measured as the number of days between birth and 60 days of life of mechanical ventialtion of laryngeal intubation.
Time Frame Birth to 60 days of life
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.
Arm/Group Title Hydrocortisone Placebo
Hide Arm/Group Description:

Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line).

1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose

Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume)

1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose

Overall Number of Participants Analyzed 6 6
Median (Full Range)
Unit of Measure: Days
8
(3 to 10)
11
(3 to 19)
5.Secondary Outcome
Title Days to Full Feeds
Hide Description The day of life at which full nipple feeds were reached between birth and 60 days of life. Full nipple feeds are defined as at least 120 mg/kg/day.
Time Frame Birth to 60 days of life
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age. Excludes 4 infants (Hydrocortisone: 1, Placebo: 3) without information on full feeds.
Arm/Group Title Hydrocortisone Placebo
Hide Arm/Group Description:

Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line).

1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose

Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume)

1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose

Overall Number of Participants Analyzed 5 3
Median (Full Range)
Unit of Measure: Days
16
(12 to 23)
18
(8 to 22)
6.Secondary Outcome
Title Number of Participants With Need for Gastronomy Tube
Hide Description This is measured as Yes if a gastronomy tube was placed anytime prior to final status between birth and 60 days of life; Otherwise, No
Time Frame Birth to 60 days of life
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.
Arm/Group Title Hydrocortisone Placebo
Hide Arm/Group Description:

Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line).

1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose

Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume)

1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose

Overall Number of Participants Analyzed 6 6
Measure Type: Count of Participants
Unit of Measure: Participants
No
6
 100.0%
6
 100.0%
Yes
0
   0.0%
0
   0.0%
7.Secondary Outcome
Title Duration of Oxygen Requirement
Hide Description This is measured as the number of days between birth and 60 days of life that an infant was on oxygen in the hospital.
Time Frame Birth to 60 days of life
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.
Arm/Group Title Hydrocortisone Placebo
Hide Arm/Group Description:

Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line).

1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose

Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume)

1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose

Overall Number of Participants Analyzed 6 6
Median (Full Range)
Unit of Measure: Days
15.5
(3 to 33)
18
(5 to 25)
8.Secondary Outcome
Title Number of Participants With Need for Home Oxygen
Hide Description This is measured as Yes if an infant was discharged to home while on oxygen between birth and 60 days of life; Otherwise, No.
Time Frame Birth to 60 days of life
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.
Arm/Group Title Hydrocortisone Placebo
Hide Arm/Group Description:

Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line).

1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose

Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume)

1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose

Overall Number of Participants Analyzed 5 6
Measure Type: Count of Participants
Unit of Measure: Participants
No
5
 100.0%
4
  66.7%
Yes
0
   0.0%
2
  33.3%
9.Secondary Outcome
Title Hospital Length of Stay
Hide Description This is measured as the number of days between birth and 60 days of life that an infant was in the hospital. Infants who died or transferred to another care facility were not included.
Time Frame Birth to 60 days of life
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.
Arm/Group Title Hydrocortisone Placebo
Hide Arm/Group Description:

Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line).

1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose

Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume)

1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose

Overall Number of Participants Analyzed 5 5
Median (Full Range)
Unit of Measure: Days
27
(14 to 60)
24
(14 to 38)
10.Secondary Outcome
Title Number of Participants With Renal Insufficiency
Hide Description This is measured as Yes if an infant had renal insufficieny between birth and 60 days of life; Otherwise, No. Renal insufficiency is defined as creatinine less than 2 during 7 days after first treatment
Time Frame Birth to 60 days of life
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.
Arm/Group Title Hydrocortisone Placebo
Hide Arm/Group Description:

Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line).

1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose

Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume)

1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose

Overall Number of Participants Analyzed 6 6
Measure Type: Count of Participants
Unit of Measure: Participants
No
6
 100.0%
6
 100.0%
Yes
0
   0.0%
0
   0.0%
11.Secondary Outcome
Title Number of Participants With Necrotizing Enterocolitis
Hide Description This is measured as Yes if an infant necrotizing enterocolitis (NEC) between birth and 60 days of life; Otherwise, No. NEC could be proven with or without surgery
Time Frame Birth to 60 days of life
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.
Arm/Group Title Hydrocortisone Placebo
Hide Arm/Group Description:

Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line).

1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose

Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume)

1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose

Overall Number of Participants Analyzed 6 6
Measure Type: Count of Participants
Unit of Measure: Participants
No
5
  83.3%
6
 100.0%
Yes
1
  16.7%
0
   0.0%
12.Secondary Outcome
Title Number of Participants With Need for ECMO Therapy
Hide Description This is measured as Yes if an infant received ECMO treatment anytime between birth and 60 days of life; Otherwise, No. Extracorporeal membrane oxygenation (ECMO) is a treatment that uses a pump to circulate blood through an artificial lung back into the bloodstream of a very ill baby.
Time Frame Birth to 60 days of life
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.
Arm/Group Title Hydrocortisone Placebo
Hide Arm/Group Description:

Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line).

1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose

Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume)

1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose

Overall Number of Participants Analyzed 6 6
Measure Type: Count of Participants
Unit of Measure: Participants
No
6
 100.0%
6
 100.0%
Yes
0
   0.0%
0
   0.0%
13.Secondary Outcome
Title Number of Participants With Inotrope Exposure
Hide Description This is measured as Yes if an infant was receiving inotropes on the specific day after the initiation of study drug.
Time Frame 24 hours prior to study drug administration through 3 days post study drug administration.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.
Arm/Group Title Hydrocortisone Placebo
Hide Arm/Group Description:

Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line).

1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose

Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume)

1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose

Overall Number of Participants Analyzed 6 6
Measure Type: Count of Participants
Unit of Measure: Participants
Day 3 No
4
  66.7%
4
  66.7%
Yes
2
  33.3%
2
  33.3%
Day 5 No
5
  83.3%
4
  66.7%
Yes
1
  16.7%
2
  33.3%
Day 7 No
5
  83.3%
5
  83.3%
Yes
1
  16.7%
1
  16.7%
14.Secondary Outcome
Title Inotrope Duration
Hide Description This is calculated as the number of days on inotropes starting 24 hours prior to initiation of study drug, during the 7-day study drug administration period, and for 3 days after the study drug.
Time Frame 24 hours prior to study drug administration through 3 days post study drug administration.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.
Arm/Group Title Hydrocortisone Placebo
Hide Arm/Group Description:

Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line).

1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose

Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume)

1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose

Overall Number of Participants Analyzed 6 6
Median (Full Range)
Unit of Measure: days
3
(1 to 8)
3
(1 to 8)
15.Secondary Outcome
Title Maximum Inotrope Dose
Hide Description This is calculated as the maximum dose of all inotropes in the 10 days following the initiation of study drug administration. For the purposes of this calculation, dopamine and dobutamine doses were considered equivalent and 0.01 mcg/kg/min of epinephrine was equal to 5 mcg/kg/min of dopamine.
Time Frame From start of study drug administration (7 days) through 3 days post study drug administration.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.
Arm/Group Title Hydrocortisone Placebo
Hide Arm/Group Description:

Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line).

1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose

Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume)

1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose

Overall Number of Participants Analyzed 6 6
Mean (Standard Deviation)
Unit of Measure: mcg/kg/min
9.5  (2.9) 14.7  (12.6)
16.Secondary Outcome
Title Oxygenation Index
Hide Description This is calculated as fraction of inspired oxygen (FiO2), as a percentage, multiplied by the mean airway pressure divided by partial pressure of oxygen in arterial blood (PaO2), during study drug administration. A lower oxygenation index is better.
Time Frame Birth to 60 days of life
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.
Arm/Group Title Hydrocortisone Placebo
Hide Arm/Group Description:

Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line).

1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose

Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume)

1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose

Overall Number of Participants Analyzed 6 6
Mean (Standard Deviation)
Unit of Measure: Oxygenation Index
Before dose 1 Number Analyzed 6 participants 6 participants
10.7  (6.1) 14.5  (8.6)
Before dose 5 Number Analyzed 6 participants 5 participants
7  (3.7) 14.9  (6.9)
Before dose 9 Number Analyzed 5 participants 5 participants
6.6  (2.1) 10.4  (5.3)
Before dose 13 Number Analyzed 5 participants 5 participants
5.8  (3) 9.2  (4.2)
Before dose 15 Number Analyzed 3 participants 3 participants
4.7  (2) 9.3  (0.8)
Before dose 17 Number Analyzed 3 participants 3 participants
5.9  (3.2) 7.9  (1.1)
Before dose 18 Number Analyzed 1 participants 3 participants
3.7 9.1  (4.6)
17.Secondary Outcome
Title Respiratory Severity
Hide Description This is calculated as fraction of inspired oxygen (FiO2), as a percentage, multiplied by the mean airway pressure during study drug administration. Higher score means more severe.
Time Frame Birth to 60 days of life
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.
Arm/Group Title Hydrocortisone Placebo
Hide Arm/Group Description:

Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line).

1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose

Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume)

1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose

Overall Number of Participants Analyzed 6 6
Mean (Standard Deviation)
Unit of Measure: Percentage of inspired oxygen * cmH2O
Before dose 1 Number Analyzed 6 participants 6 participants
726.8  (371) 1184.7  (518.7)
Before dose 5 Number Analyzed 6 participants 5 participants
518.8  (272.5) 1041.2  (432.6)
Before dose 9 Number Analyzed 5 participants 5 participants
531.6  (196.5) 925.8  (611.8)
Before dose 13 Number Analyzed 5 participants 5 participants
414.6  (230) 776.8  (411.2)
Before dose 15 Number Analyzed 4 participants 3 participants
423  (158.8) 899  (453.4)
Before dose 17 Number Analyzed 3 participants 4 participants
323  (117.8) 785.8  (463.2)
Before dose 18 Number Analyzed 2 participants 3 participants
308.5  (139.3) 694.7  (274)
18.Secondary Outcome
Title Number of Participants With Fluid Boluses Given
Hide Description This is measured as Yes if an infant received fluid boluses anytime before or during study drug administration between birth and 60 days of life; Otherwise, No.
Time Frame Birth to 60 days of life
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.
Arm/Group Title Hydrocortisone Placebo
Hide Arm/Group Description:

Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line).

1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose

Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume)

1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose

Overall Number of Participants Analyzed 6 6
Measure Type: Count of Participants
Unit of Measure: Participants
Before dose 1 Number Analyzed 6 participants 6 participants
No
2
  33.3%
2
  33.3%
Yes
4
  66.7%
4
  66.7%
Before dose 5 Number Analyzed 6 participants 6 participants
No
5
  83.3%
4
  66.7%
Yes
1
  16.7%
2
  33.3%
Before dose 9 Number Analyzed 6 participants 6 participants
No
5
  83.3%
5
  83.3%
Yes
1
  16.7%
1
  16.7%
Before dose 13 Number Analyzed 6 participants 6 participants
No
5
  83.3%
6
 100.0%
Yes
1
  16.7%
0
   0.0%
Before dose 15 Number Analyzed 6 participants 5 participants
No
6
 100.0%
4
  80.0%
Yes
0
   0.0%
1
  20.0%
Before dose 17 Number Analyzed 6 participants 6 participants
No
6
 100.0%
6
 100.0%
Yes
0
   0.0%
0
   0.0%
Before dose 18 Number Analyzed 6 participants 6 participants
No
6
 100.0%
6
 100.0%
Yes
0
   0.0%
0
   0.0%
19.Secondary Outcome
Title Number of Boluses Given
Hide Description The number of fluid boluses given per participant, if any, before or during study drug administration between birth and 60 days of life
Time Frame Birth to 60 days of life
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.
Arm/Group Title Hydrocortisone Placebo
Hide Arm/Group Description:

Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line).

1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose

Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume)

1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose

Overall Number of Participants Analyzed 5 5
Median (Full Range)
Unit of Measure: Boluses
Before dose 1 Number Analyzed 4 participants 4 participants
3
(1 to 7)
3
(2 to 8)
Before dose 5 Number Analyzed 1 participants 2 participants
2
(2 to 2)
1
(1 to 1)
Before dose 9 Number Analyzed 1 participants 1 participants
2
(2 to 2)
1
(1 to 1)
Before dose 13 Number Analyzed 1 participants 0 participants
1
(1 to 1)
Before dose 15 Number Analyzed 0 participants 1 participants
1
(1 to 1)
Time Frame 10 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Hydrocortisone Placebo
Hide Arm/Group Description

hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line Hydrocortisone: • 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line).

1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose

Saline placebo Placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume)

1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose

All-Cause Mortality
Hydrocortisone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)      0/6 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Hydrocortisone Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/6 (16.67%)      0/6 (0.00%)    
Blood and lymphatic system disorders     
HYPERBILIRUBINEMIA REQUIRING EXCHANGE TRANSFUSION   1/6 (16.67%)  1 0/6 (0.00%)  0
Cardiac disorders     
HYPERTENSION, NEW AND SUSTAINED   1/6 (16.67%)  2 0/6 (0.00%)  0
Endocrine disorders     
ADRENAL INSUFFICIENCY   1/6 (16.67%)  1 0/6 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.00%
Hydrocortisone Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/6 (0.00%)      1/6 (16.67%)    
Cardiac disorders     
ATRIAL TACHYCARDIA   0/6 (0.00%)  0 1/6 (16.67%)  1
Indicates events were collected by systematic assessment
The study was closed to enrollment after 12 participants due to slow recruitment.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Investigators must adhere to the Neonatal Research Network Publication policies
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Kristi Watterberg
Organization: University of New Mexico
Phone: 505-272-8609
EMail: KWatterberg@salud.unm.edu
Layout table for additonal information
Responsible Party: NICHD Neonatal Research Network
ClinicalTrials.gov Identifier: NCT01954056     History of Changes
Other Study ID Numbers: NICHD-NRN-0052
U10HD021364 ( U.S. NIH Grant/Contract )
U10HD040689 ( U.S. NIH Grant/Contract )
U10HD021385 ( U.S. NIH Grant/Contract )
U10HD027851 ( U.S. NIH Grant/Contract )
U10HD027853 ( U.S. NIH Grant/Contract )
U10HD027856 ( U.S. NIH Grant/Contract )
U10HD027904 ( U.S. NIH Grant/Contract )
U10HD027880 ( U.S. NIH Grant/Contract )
U10HD034216 ( U.S. NIH Grant/Contract )
U10HD021373 ( U.S. NIH Grant/Contract )
U10HD040492 ( U.S. NIH Grant/Contract )
U10HD053109 ( U.S. NIH Grant/Contract )
U10HD040461 ( U.S. NIH Grant/Contract )
U10HD068244 ( U.S. NIH Grant/Contract )
U10HD068263 ( U.S. NIH Grant/Contract )
U10HD068270 ( U.S. NIH Grant/Contract )
U10HD068278 ( U.S. NIH Grant/Contract )
U10HD068284 ( U.S. NIH Grant/Contract )
U10HD036790 ( U.S. NIH Grant/Contract )
First Submitted: September 26, 2013
First Posted: October 1, 2013
Results First Submitted: January 18, 2019
Results First Posted: April 2, 2019
Last Update Posted: April 2, 2019