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Incubator Weaning of Moderately Preterm Infants

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ClinicalTrials.gov Identifier: NCT02160002
Recruitment Status : Completed
First Posted : June 10, 2014
Results First Posted : December 21, 2017
Last Update Posted : March 22, 2019
Sponsor:
Collaborator:
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: None (Open Label);   Primary Purpose: Treatment
Conditions Infant, Newborn
Infant, Moderate Preterm
Interventions Procedure: Weaning from an incubator at a lower weight (1600 grams)
Procedure: Weaning from an incubator at a higher weight (1800 grams)
Enrollment 366
Recruitment Details  
Pre-assignment Details 1565 infants were screened for eligibility. 1199 infants were excluded. 680 were excluded due to not meeting all eligibility conditions, 510 did not get consent for randomization, and 9 were consented but not randomized due to parent (1 infant) or doctor withdrawal (1 infant), becoming medically unstable (3 infants) or other reasons (4 infants).
Arm/Group Title Lower Weight (1600 Grams) Higher Weight (1800 Grams)
Hide Arm/Group Description Weaning from an incubator at a lower weight (1600 grams) Weaning from an incubator at a higher weight (1800 grams)
Period Title: Overall Study
Started 187 179
Primary Outcome 185 178
Completed 185 178
Not Completed 2 1
Reason Not Completed
Withdrawal by Subject             2             1
Arm/Group Title Lower Weight (1600 Grams) Higher Weight (1800 Grams) Total
Hide Arm/Group Description Weaning from an incubator at a lower weight (1600 grams) Weaning from an incubator at a higher weight (1800 grams) Total of all reporting groups
Overall Number of Baseline Participants 187 179 366
Hide Baseline Analysis Population Description
A total of 366 infants were randomized in the study. 187 infants were randomized to the Lower Weight group. 179 infants were randomized to the Higher Weight group. The baseline statistics are based on the number of mothers or infants for whom data were available.
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Weeks
Gestational Age Number Analyzed 187 participants 179 participants 366 participants
31.2  (1.3) 31.1  (1.2) 31.1  (1.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 187 participants 179 participants 366 participants
Female
93
  49.7%
87
  48.6%
180
  49.2%
Male
94
  50.3%
92
  51.4%
186
  50.8%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 187 participants 179 participants 366 participants
Black
76
  40.6%
72
  40.2%
148
  40.4%
White
99
  52.9%
97
  54.2%
196
  53.6%
Other
12
   6.4%
10
   5.6%
22
   6.0%
Postmenstrual (PMA) age at start of weaning  
Mean (Standard Deviation)
Unit of measure:  Weeks
Number Analyzed 187 participants 179 participants 366 participants
33.8  (1.3) 34.3  (1.2) 34.1  (1.3)
Maternal Age  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 187 participants 179 participants 366 participants
28.8  (5.8) 28.9  (6.1) 28.8  (5.9)
Cesarean Delivery  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 187 participants 179 participants 366 participants
136
  72.7%
122
  68.2%
258
  70.5%
1.Primary Outcome
Title Length of Hospital Stay (LOS) From Birth to Discharge (up to 120 Days)
Hide Description Number of days the infant stays in hospital after birth until discharge home (up to 120 days).
Time Frame From birth through discharge
Hide Outcome Measure Data
Hide Analysis Population Description
185 infants in the lower weight group and 178 infants in the higher weight group have the date of discharge available.
Arm/Group Title Lower Weight (1600 Grams) Higher Weight (1800 Grams)
Hide Arm/Group Description:
Weaning from an incubator at a lower weight (1600 grams)
Weaning from an incubator at a higher weight (1800 grams)
Overall Number of Participants Analyzed 185 178
Median (Inter-Quartile Range)
Unit of Measure: days
43
(32 to 55)
41
(33 to 52)
2.Secondary Outcome
Title Length of Stay (LOS) Following Weaning From Incubator to Crib to Hospital Discharge (up to 120 Days)
Hide Description Among infants who were successfully weaned, the number of days in the hospital counting from the start of weaning from the incubator to the crib through discharge from the hospital (up to 120 days).
Time Frame From start of weaning from the incubator to crib through discharge (up to 120 days)
Hide Outcome Measure Data
Hide Analysis Population Description
There were 163 infants in the Lower Weight group that were successfully weaned from incubator to the crib; discharge date was missing for one of these infants. There were 159 infants in the Higher Weight group that were successfully weaned from incubator to the crib; 4 infants were missing start of weaning dates because of protocol violations.
Arm/Group Title Lower Weight (1600 Grams) Higher Weight (1800 Grams)
Hide Arm/Group Description:
Weaning from an incubator at a lower weight (1600 grams)
Weaning from an incubator at a higher weight (1800 grams)
Overall Number of Participants Analyzed 162 155
Median (Inter-Quartile Range)
Unit of Measure: days
24
(14 to 35)
19
(10 to 26)
3.Secondary Outcome
Title Failure Rate of Weaning to Crib (Number of Infants With Axillary Temperature < 36.3°C After 2 Weaning Attempts)
Hide Description Failure of wean is defined as axillary temperature less than 36.3°C after one hour in the crib on 2 successive readings, 3 to 4 hours apart, within 24 hours of weaning to the crib in spite of additional clothes/coverings.
Time Frame Through completion of 2 weaning attempts
Hide Outcome Measure Data
Hide Analysis Population Description
178 infants in the Lower Weight group and 167 infants in the Higher Weight group have the data on whether weaning from incubator to crib was successful after two attempts at weaning.
Arm/Group Title Lower Weight (1600 Grams) Higher Weight (1800 Grams)
Hide Arm/Group Description:
Weaning from an incubator at a lower weight (1600 grams)
Weaning from an incubator at a higher weight (1800 grams)
Overall Number of Participants Analyzed 178 167
Measure Type: Count of Participants
Unit of Measure: Participants
15
   8.4%
8
   4.8%
4.Secondary Outcome
Title Growth Velocity (Weight in Grams/kg/Day) From Start of Weaning From Incubator (Following Random Assignment) to 36 Weeks Postmenstrual Age (PMA)
Hide Description Growth velocity in terms of weight (g/kg/day), considering infant weight at start of weaning from incubator to crib (following random assignment) and weight at 36 weeks postmenstrual age (PMA).
Time Frame Start of weaning from incubator through 36 weeks postmenstrual age (PMA)
Hide Outcome Measure Data
Hide Analysis Population Description
There were 257 (136 LW and 121 HW) infants who remained in the hospital at 36 weeks PMA that have weights measured at 36 weeks PMA. Twenty six infants (10 LW and 16 HW) who were still in the incubator at 36 weeks PMA and 20 infants (7 LW and 13 HW) missing the date of start of weaning were excluded from the analysis.
Arm/Group Title Lower Weight (1600 Grams) Higher Weight (1800 Grams)
Hide Arm/Group Description:
Weaning from an incubator at a lower weight (1600 grams)
Weaning from an incubator at a higher weight (1800 grams)
Overall Number of Participants Analyzed 119 92
Mean (Standard Deviation)
Unit of Measure: grams/kilograms/day
15.8  (4.8) 15.8  (4.1)
5.Secondary Outcome
Title Growth Parameters: Weight at Status
Hide Description Infant weight at status is measured at the time of discharge, death, transfer to another facility, or 120 days.
Time Frame Status (discharge, death, transfer to another facility, or 120 days)
Hide Outcome Measure Data
Hide Analysis Population Description
185 infants in the Lower Weight group and 177 infants in the Higher Weight group had their weights recorded upon reaching status.
Arm/Group Title Lower Weight (1600 Grams) Higher Weight (1800 Grams)
Hide Arm/Group Description:
Weaning from an incubator at a lower weight (1600 grams)
Weaning from an incubator at a higher weight (1800 grams)
Overall Number of Participants Analyzed 185 177
Mean (Standard Deviation)
Unit of Measure: grams
2336.3  (648.0) 2353.6  (522.0)
6.Secondary Outcome
Title Growth Parameters: Length at Status
Hide Description Infant length at status is measured at the time of discharge, death, transfer to another facility, or 120 days.
Time Frame Status (discharge, death, transfer to another facility, or 120 days)
Hide Outcome Measure Data
Hide Analysis Population Description
174 infants in the Lower Weight group and 169 infants in the Higher Weight group have the length at status data.
Arm/Group Title Lower Weight (1600 Grams) Higher Weight (1800 Grams)
Hide Arm/Group Description:
Weaning from an incubator at a lower weight (1600 grams)
Weaning from an incubator at a higher weight (1800 grams)
Overall Number of Participants Analyzed 174 169
Mean (Standard Deviation)
Unit of Measure: centimeters
44.6  (3.2) 44.9  (2.9)
7.Secondary Outcome
Title Growth Parameters: Head Circumference at Status
Hide Description Infant head circumference at status is measured at the time of discharge, death, transfer to another facility, or 120 days.
Time Frame Status (discharge, death, transfer to another facility, or 120 days)
Hide Outcome Measure Data
Hide Analysis Population Description
182 infants in the Lower Weight group and 173 infants in the Higher Weight group have the head circumference at status data.
Arm/Group Title Lower Weight (1600 Grams) Higher Weight (1800 Grams)
Hide Arm/Group Description:
Weaning from an incubator at a lower weight (1600 grams)
Weaning from an incubator at a higher weight (1800 grams)
Overall Number of Participants Analyzed 182 173
Mean (Standard Deviation)
Unit of Measure: centimeters
31.9  (2.2) 32.0  (2.0)
8.Secondary Outcome
Title Postmenstrual Age (PMA) at Discharge
Hide Description Postmenstrual age (PMA) at discharge is the sum of the gestational age of the infant and its length of stay in hospital from birth to discharge.
Time Frame Discharge
Hide Outcome Measure Data
Hide Analysis Population Description
185 infants in the Lower Weight group and 178 infants in the Higher Weight group have postmenstrual age (PMA) at discharge data.
Arm/Group Title Lower Weight (1600 Grams) Higher Weight (1800 Grams)
Hide Arm/Group Description:
Weaning from an incubator at a lower weight (1600 grams)
Weaning from an incubator at a higher weight (1800 grams)
Overall Number of Participants Analyzed 185 178
Median (Inter-Quartile Range)
Unit of Measure: weeks
37.1
(36.3 to 38.9)
37.0
(36.0 to 38.3)
9.Secondary Outcome
Title Readmission to the Hospital Within 1 Week of Discharge
Hide Description Number of infants re-hospitalized within 1 week (7 days) of discharge.
Time Frame Discharge through 1 week after discharge.
Hide Outcome Measure Data
Hide Analysis Population Description
174 infants in the Lower Weight group and 168 infants in the Higher Weight group had post discharge follow-up.
Arm/Group Title Lower Weight (1600 Grams) Higher Weight (1800 Grams)
Hide Arm/Group Description:
Weaning from an incubator at a lower weight (1600 grams)
Weaning from an incubator at a higher weight (1800 grams)
Overall Number of Participants Analyzed 174 168
Measure Type: Count of Participants
Unit of Measure: Participants
6
   3.4%
2
   1.2%
10.Secondary Outcome
Title Death Among Enrolled Infants
Hide Description [Not Specified]
Time Frame Status (discharge, death, transfer to another facility, or 120 days)
Hide Outcome Measure Data
Hide Analysis Population Description
185 infants in the Lower Weight group and 178 infants in the Higher Weight group have status data.
Arm/Group Title Lower Weight (1600 Grams) Higher Weight (1800 Grams)
Hide Arm/Group Description:
Weaning from an incubator at a lower weight (1600 grams)
Weaning from an incubator at a higher weight (1800 grams)
Overall Number of Participants Analyzed 185 178
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
11.Secondary Outcome
Title Transferred to a Non-Network Hospital
Hide Description Number of infants transferred to another non-Network hospital.
Time Frame Status (discharge, death, transfer to another facility, or 120 days)
Hide Outcome Measure Data
Hide Analysis Population Description
185 infants in the Lower Weight group and 178 infants in the Higher Weight group have status data.
Arm/Group Title Lower Weight (1600 Grams) Higher Weight (1800 Grams)
Hide Arm/Group Description:
Weaning from an incubator at a lower weight (1600 grams)
Weaning from an incubator at a higher weight (1800 grams)
Overall Number of Participants Analyzed 185 178
Measure Type: Count of Participants
Unit of Measure: Participants
11
   5.9%
9
   5.1%
12.Secondary Outcome
Title Length of Stay (LOS) Following Randomization to Hospital Discharge
Hide Description The number of days the infant stayed in hospital after randomization to the study until discharge.
Time Frame From randomization through discharge.
Hide Outcome Measure Data
Hide Analysis Population Description
185 infants in the Lower Weight group and 178 infants in the Higher Weight group have the date of discharge.
Arm/Group Title Lower Weight (1600 Grams) Higher Weight (1800 Grams)
Hide Arm/Group Description:
Weaning from an incubator at a lower weight (1600 grams)
Weaning from an incubator at a higher weight (1800 grams)
Overall Number of Participants Analyzed 185 178
Median (Inter-Quartile Range)
Unit of Measure: days
28
(19 to 39)
27.5
(20 to 37)
13.Post-Hoc Outcome
Title Growth Velocity (g/kg/Day) After Transfer to Crib From Incubator to Crib to 36 Weeks Postmenstural Age (PMA)
Hide Description Growth velocity in terms of weight (g/kg/day), considering infant weight at 24 hours after successful wean to crib and weight at 36 weeks postmenstrual age (PMA).
Time Frame 24 hours after successful wean to 36 weeks postmenstrual age (PMA)
Hide Outcome Measure Data
Hide Analysis Population Description
257 infants (136 LW, 121 HW) remained in hospital at 36 weeks PMA w/ weight measured at 36 weeks PMA. 26 (10 LW, 16 HW) were still in incubator at 36 weeks PMA, 31 (16 LW, 15 HW) were missing weight after 24 hrs of successful wean, and 4 (LW) w/ weights measured at 24 hrs after successful wean were missing date of 24 hr weight after successful wean
Arm/Group Title Lower Weight (1600 Grams) Higher Weight (1800 Grams)
Hide Arm/Group Description:
Weaning from an incubator at a lower weight (1600 grams)
Weaning from an incubator at a higher weight (1800 grams)
Overall Number of Participants Analyzed 106 90
Mean (Standard Deviation)
Unit of Measure: grams/kilograms/day
11.0  (7.4) 9.6  (7.0)
Time Frame Adverse events are monitored from the time of randomization through 72 hours post study intervention completion. The study intervention period is defined as from the time of randomization to the end of a successful wean or failure.
Adverse Event Reporting Description Potential adverse events include inability to maintain temperature in crib, bradycardia, weight loss or lack of weight gain and feeding intolerance during the safety monitoring period.
 
Arm/Group Title Lower Weight (1600 Grams) Higher Weight (1800 Grams)
Hide Arm/Group Description Weaning from an incubator at a lower weight (1600 grams) Weaning from an incubator at a higher weight (1800 grams)
All-Cause Mortality
Lower Weight (1600 Grams) Higher Weight (1800 Grams)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/187 (0.00%)      0/179 (0.00%)    
Hide Serious Adverse Events
Lower Weight (1600 Grams) Higher Weight (1800 Grams)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/187 (0.53%)      0/179 (0.00%)    
Gastrointestinal disorders     
Pneumoperitoneum   1/187 (0.53%)  1 0/179 (0.00%)  0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lower Weight (1600 Grams) Higher Weight (1800 Grams)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   19/187 (10.16%)      7/179 (3.91%)    
Cardiac disorders     
Bradycardia   2/187 (1.07%)  3 2/179 (1.12%)  3
Tachycardia with desaturations   1/187 (0.53%)  1 0/179 (0.00%)  0
Increasing heart failure   1/187 (0.53%)  1 0/179 (0.00%)  0
Gastrointestinal disorders     
Feeding Intolerance   1/187 (0.53%)  3 2/179 (1.12%)  3
NEC IIa   1/187 (0.53%)  1 0/179 (0.00%)  0
Metabolism and nutrition disorders     
Moderate cold stress   10/187 (5.35%)  10 3/179 (1.68%)  3
Severe cold stress   3/187 (1.60%)  4 1/179 (0.56%)  1
Respiratory, thoracic and mediastinal disorders     
Desaturations   0/187 (0.00%)  0 1/179 (0.56%)  1
Respiratory distress   1/187 (0.53%)  1 0/179 (0.00%)  0
Indicates events were collected by systematic assessment
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: Seetha Shankaran
Organization: Wayne State University
Phone: (313) 745-1436
EMail: sshankar@med.wayne.edu
Layout table for additonal information
Responsible Party: NICHD Neonatal Research Network
ClinicalTrials.gov Identifier: NCT02160002    
Other Study ID Numbers: NICHD-NRN-0054
First Submitted: May 8, 2014
First Posted: June 10, 2014
Results First Submitted: November 28, 2017
Results First Posted: December 21, 2017
Last Update Posted: March 22, 2019