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Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass

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ClinicalTrials.gov Identifier: NCT01579513
Recruitment Status : Completed
First Posted : April 18, 2012
Results First Posted : June 18, 2019
Last Update Posted : December 9, 2019
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Medical University of South Carolina

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Congenital Heart Disease
Disorder of Fetus or Newborn
Interventions Drug: Methylprednisolone
Drug: Placebo
Enrollment 190
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intraoperative Methylprednisone Placebo
Hide Arm/Group Description

Neonates with congenital heart disease requiring surgery utilizing cardiopulmonary bypass(CPB) in the first month of life that receive one dose of intravenous methylprednisolone (30 mg/kg) during anesthetic induction.

Methylprednisolone: Methylprednisolone at a dose of 30 mg/kg body weight and a concentration of 62.5 mg/cc. The study drug will be delivered in a blinded fashion to the anesthesiologist and will be administered intravenously with the induction of anesthesia.

Neonates with congenital heart disease requiring surgery utilizing cardiopulmonary bypass (CPB) in the first month of life that receive one dose of placebo (normal saline) during anesthetic induction.

Placebo: Normal saline will be drawn up in an identical volume to that needed for active study drug. The study drug will be delivered in a blinded fashion to the anesthesiologist and will be administered intravenously with the induction of anesthesia.

Period Title: Primary Hospitalization
Started 91 99
Completed 81 95
Not Completed 10 4
Period Title: 1 Year Neurodevelopmental Follow up
Started 81 95
Completed 61 68
Not Completed 20 27
Arm/Group Title Intraoperative Methylprednisone Placebo Total
Hide Arm/Group Description

Neonates with congenital heart disease requiring surgery utilizing cardiopulmonary bypass(CPB) in the first month of life that receive one dose of intravenous methylprednisolone (30 mg/kg) during anesthetic induction.

Methylprednisolone: Methylprednisolone at a dose of 30 mg/kg body weight and a concentration of 62.5 mg/cc. The study drug will be delivered in a blinded fashion to the anesthesiologist and will be administered intravenously with the induction of anesthesia.

Neonates with congenital heart disease requiring surgery utilizing cardiopulmonary bypass (CPB) in the first month of life that receive one dose of placebo (normal saline) during anesthetic induction.

Placebo: Normal saline will be drawn up in an identical volume to that needed for active study drug. The study drug will be delivered in a blinded fashion to the anesthesiologist and will be administered intravenously with the induction of anesthesia.

Total of all reporting groups
Overall Number of Baseline Participants 81 95 176
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 81 participants 95 participants 176 participants
9.1  (5.4) 8.2  (5.6) 8.6  (5.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants 95 participants 176 participants
Female
35
  43.2%
35
  36.8%
70
  39.8%
Male
46
  56.8%
60
  63.2%
106
  60.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants 95 participants 176 participants
Hispanic or Latino
4
   4.9%
8
   8.4%
12
   6.8%
Not Hispanic or Latino
77
  95.1%
87
  91.6%
164
  93.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants 95 participants 176 participants
American Indian or Alaska Native
0
   0.0%
1
   1.1%
1
   0.6%
Asian
0
   0.0%
2
   2.1%
2
   1.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
22
  27.2%
27
  28.4%
49
  27.8%
White
55
  67.9%
60
  63.2%
115
  65.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
4
   4.9%
5
   5.3%
9
   5.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 81 participants 95 participants 176 participants
81 95 176
Weight at surgery   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 81 participants 95 participants 176 participants
3.2  (0.5) 3.4  (0.5) 3.3  (0.5)
[1]
Measure Description: Weight in Kg at the time of surgery
1.Primary Outcome
Title Number of Participants With a Clinically Derived Composite Morbidity-mortality Outcome
Hide Description The composite morbidity-mortality outcome will be met if any of the following occur after surgery but before hospital discharge: death, cardiac arrest, extracorporeal membrane oxygenation, renal insufficiency (creatinine more than two times normal), hepatic insufficiency (aspartate aminotransferase or alanine aminotransferase more than two times normal), or rising lactic acidosis (>5mmol/L). This outcome was choosen because death rarely occurs in this population. We have found this endpoint to be highly associated with other important clinical outcomes in this population.
Time Frame Participants will be followed for the duration of hospital stay, an expected average of 5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intraoperative Methylprednisone Placebo
Hide Arm/Group Description:

Neonates with congenital heart disease requiring surgery utilizing cardiopulmonary bypass(CPB) in the first month of life that receive one dose of intravenous methylprednisolone (30 mg/kg) during anesthetic induction.

Methylprednisolone: Methylprednisolone at a dose of 30 mg/kg body weight and a concentration of 62.5 mg/cc. The study drug will be delivered in a blinded fashion to the anesthesiologist and will be administered intravenously with the induction of anesthesia.

Neonates with congenital heart disease requiring surgery utilizing cardiopulmonary bypass (CPB) in the first month of life that receive one dose of placebo (normal saline) during anesthetic induction.

Placebo: Normal saline will be drawn up in an identical volume to that needed for active study drug. The study drug will be delivered in a blinded fashion to the anesthesiologist and will be administered intravenously with the induction of anesthesia.

Overall Number of Participants Analyzed 81 95
Measure Type: Count of Participants
Unit of Measure: Participants
27
  33.3%
40
  42.1%
2.Secondary Outcome
Title Duration of Mechanical Ventilation Post Cardiac Surgery.
Hide Description Amount of time on mechanical ventilation following cardiac surgery
Time Frame Participants will be followed for the duration of hospital stay, an expected average of 5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intraoperative Methylprednisone Placebo
Hide Arm/Group Description:

Neonates with congenital heart disease requiring surgery utilizing cardiopulmonary bypass(CPB) in the first month of life that receive one dose of intravenous methylprednisolone (30 mg/kg) during anesthetic induction.

Methylprednisolone: Methylprednisolone at a dose of 30 mg/kg body weight and a concentration of 62.5 mg/cc. The study drug will be delivered in a blinded fashion to the anesthesiologist and will be administered intravenously with the induction of anesthesia.

Neonates with congenital heart disease requiring surgery utilizing cardiopulmonary bypass (CPB) in the first month of life that receive one dose of placebo (normal saline) during anesthetic induction.

Placebo: Normal saline will be drawn up in an identical volume to that needed for active study drug. The study drug will be delivered in a blinded fashion to the anesthesiologist and will be administered intravenously with the induction of anesthesia.

Overall Number of Participants Analyzed 81 95
Median (Inter-Quartile Range)
Unit of Measure: Days
4
(3 to 7)
5
(3 to 8)
3.Secondary Outcome
Title Intensive Care Unit Stay
Hide Description Amount of time in the intensive care unit following cardiac surgery
Time Frame Participants will be followed for the duration of hospital stay, an expected average of 5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intraoperative Methylprednisone Placebo
Hide Arm/Group Description:

Neonates with congenital heart disease requiring surgery utilizing cardiopulmonary bypass(CPB) in the first month of life that receive one dose of intravenous methylprednisolone (30 mg/kg) during anesthetic induction.

Methylprednisolone: Methylprednisolone at a dose of 30 mg/kg body weight and a concentration of 62.5 mg/cc. The study drug will be delivered in a blinded fashion to the anesthesiologist and will be administered intravenously with the induction of anesthesia.

Neonates with congenital heart disease requiring surgery utilizing cardiopulmonary bypass (CPB) in the first month of life that receive one dose of placebo (normal saline) during anesthetic induction.

Placebo: Normal saline will be drawn up in an identical volume to that needed for active study drug. The study drug will be delivered in a blinded fashion to the anesthesiologist and will be administered intravenously with the induction of anesthesia.

Overall Number of Participants Analyzed 81 95
Mean (Inter-Quartile Range)
Unit of Measure: Days
11
(7 to 18)
11
(7 to 20)
4.Secondary Outcome
Title Hospital Stay
Hide Description Total duration of hospital stay following cardiac surgery
Time Frame Participants will be followed for the duration of hospital stay, an expected average of 5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intraoperative Methylprednisone Placebo
Hide Arm/Group Description:

Neonates with congenital heart disease requiring surgery utilizing cardiopulmonary bypass(CPB) in the first month of life that receive one dose of intravenous methylprednisolone (30 mg/kg) during anesthetic induction.

Methylprednisolone: Methylprednisolone at a dose of 30 mg/kg body weight and a concentration of 62.5 mg/cc. The study drug will be delivered in a blinded fashion to the anesthesiologist and will be administered intravenously with the induction of anesthesia.

Neonates with congenital heart disease requiring surgery utilizing cardiopulmonary bypass (CPB) in the first month of life that receive one dose of placebo (normal saline) during anesthetic induction.

Placebo: Normal saline will be drawn up in an identical volume to that needed for active study drug. The study drug will be delivered in a blinded fashion to the anesthesiologist and will be administered intravenously with the induction of anesthesia.

Overall Number of Participants Analyzed 81 95
Mean (Inter-Quartile Range)
Unit of Measure: Days
20
(13 to 35)
22
(12 to 35)
5.Secondary Outcome
Title Neurodevelopmental Outcome
Hide Description Bayley Scales of Infant and Toddler Development version 3 at 1 year. Cognitive, language, and motor composite scores will be used. The general population has a mean of 100 with a standard deviation of 15 for each composite score. Higher scores are better. The minimum composite score is 46 and maximum 154.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intraoperative Methylprednisone Placebo
Hide Arm/Group Description:

Neonates with congenital heart disease requiring surgery utilizing cardiopulmonary bypass(CPB) in the first month of life that receive one dose of intravenous methylprednisolone (30 mg/kg) during anesthetic induction.

Methylprednisolone: Methylprednisolone at a dose of 30 mg/kg body weight and a concentration of 62.5 mg/cc. The study drug will be delivered in a blinded fashion to the anesthesiologist and will be administered intravenously with the induction of anesthesia.

Neonates with congenital heart disease requiring surgery utilizing cardiopulmonary bypass (CPB) in the first month of life that receive one dose of placebo (normal saline) during anesthetic induction.

Placebo: Normal saline will be drawn up in an identical volume to that needed for active study drug. The study drug will be delivered in a blinded fashion to the anesthesiologist and will be administered intravenously with the induction of anesthesia.

Overall Number of Participants Analyzed 61 68
Mean (Standard Deviation)
Unit of Measure: score on a scale
Cognitive Domain 105  (15) 104  (14)
Language Domain 101  (15) 100  (13)
Motor Domain 90  (16) 91  (19)
Time Frame For the entirety of the initial neonatal hospitalization, an expected average of up to 5 weeks
Adverse Event Reporting Description Death or the use of extracorporeal membrane oxygenation
 
Arm/Group Title Intraoperative Methylprednisone Placebo
Hide Arm/Group Description

Neonates with congenital heart disease requiring surgery utilizing cardiopulmonary bypass(CPB) in the first month of life that receive one dose of intravenous methylprednisolone (30 mg/kg) during anesthetic induction.

Methylprednisolone: Methylprednisolone at a dose of 30 mg/kg body weight and a concentration of 62.5 mg/cc. The study drug will be delivered in a blinded fashion to the anesthesiologist and will be administered intravenously with the induction of anesthesia.

Neonates with congenital heart disease requiring surgery utilizing cardiopulmonary bypass (CPB) in the first month of life that receive one dose of placebo (normal saline) during anesthetic induction.

Placebo: Normal saline will be drawn up in an identical volume to that needed for active study drug. The study drug will be delivered in a blinded fashion to the anesthesiologist and will be administered intravenously with the induction of anesthesia.

All-Cause Mortality
Intraoperative Methylprednisone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   5/81 (6.17%)   6/95 (6.32%) 
Hide Serious Adverse Events
Intraoperative Methylprednisone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   4/81 (4.94%)   11/95 (11.58%) 
Cardiac disorders     
Extracorporeal membrane oxygenation   4/81 (4.94%)  11/95 (11.58%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intraoperative Methylprednisone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   2/81 (2.47%)   2/95 (2.11%) 
Endocrine disorders     
Insulin therapy   2/81 (2.47%)  2/95 (2.11%) 
Indicates events were collected by systematic assessment
Nearly one third of the subjects received additional steroids in the early postoperative period, potentially diminishing the ability to detect both beneficial and adverse effects.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Eric Graham, MD
Organization: Medical University of South Carolina
Phone: 843-792-9570
EMail: grahamem@musc.edu
Publications:
Layout table for additonal information
Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01579513    
Other Study ID Numbers: Pro16545
R01HL112968 ( U.S. NIH Grant/Contract )
First Submitted: April 13, 2012
First Posted: April 18, 2012
Results First Submitted: May 7, 2019
Results First Posted: June 18, 2019
Last Update Posted: December 9, 2019