ClinicalTrials.gov

History of Changes for Study: NCT02160002
Incubator Weaning of Moderately Preterm Infants
Latest version (submitted March 20, 2019) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 June 6, 2014 None (earliest Version on record)
2 March 18, 2015 Recruitment Status, Study Status, Contacts/Locations and Oversight
3 March 31, 2015 Arms and Interventions and Study Status
4 April 8, 2015 Contacts/Locations and Study Status
5 October 5, 2015 Sponsor/Collaborators, Study Identification, Study Status and Contacts/Locations
6 March 22, 2016 Study Status and Contacts/Locations
7 October 12, 2016 Recruitment Status, Study Status, Contacts/Locations and Study Design
8 March 27, 2017 Recruitment Status and Study Status
9 April 24, 2017 Study Status
10 May 9, 2017 Study Status
11 November 28, 2017 Recruitment Status, Study Status, Outcome Measures and Results
12 December 21, 2017 Outcome Measures and Study Status
13 March 20, 2019 Study Status
Comparison Format:

Scroll up to access the controls

Study NCT02160002
Submitted Date:  December 21, 2017 (v12)

Open or close this module Study Identification
Unique Protocol ID: NICHD-NRN-0054
Brief Title: Incubator Weaning of Moderately Preterm Infants
Official Title: Incubator Weaning of Moderately Preterm Infants: A Randomized Controlled Trial
Secondary IDs:
Open or close this module Study Status
Record Verification: December 2017
Overall Status: Completed
Study Start: February 2015
Primary Completion: July 2016 [Actual]
Study Completion: June 2017 [Actual]
First Submitted: May 8, 2014
First Submitted that
Met QC Criteria:
June 6, 2014
First Posted: June 10, 2014 [Estimate]
Results First Submitted: November 28, 2017
Results First Submitted that
Met QC Criteria:
November 28, 2017
Results First Posted: December 21, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:
December 21, 2017
Last Update Posted: January 23, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: NICHD Neonatal Research Network
Responsible Party: Sponsor
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary:

The objective of this proposal is to evaluate whether weaning from an incubator to a crib at lower versus higher weight, 1600g or 1800g will result in shorter length of hospital stay among moderately preterm infants.

The hypothesis of this study is that length of hospital stay (from birth to discharge) will be decreased among moderate preterm infants weaned from an incubator to an open crib at a lower versus higher weight, 1600g vs. 1800g.

Detailed Description:
Open or close this module Conditions
Conditions: Infant, Newborn
Infant, Moderate Preterm
Keywords: Incubator Weaning
Moderately Preterm Infants
Growth Velocity
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 366 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: Lower Weight (1600 grams)
Weaning from an incubator at a lower weight (1600 grams)
Procedure: Weaning from an incubator at a lower weight (1600 grams)
Infants will be weaned from an incubator at a lower weight (1600 grams)
Active Comparator: Higher Weight (1800 grams)
Weaning from an incubator at a higher weight (1800 grams)
Procedure: Weaning from an incubator at a higher weight (1800 grams)
Infants will be weaned from an incubator at a higher weight (1800 grams)
Open or close this module Outcome Measures
[See Results Section.]
Primary Outcome Measures:
1. Length of Hospital Stay (LOS) From Birth to Discharge (up to 120 Days)
[ Time Frame: From birth through discharge ]

Number of days the infant stays in hospital after birth until discharge home (up to 120 days).
Secondary Outcome Measures:
1. Length of Stay (LOS) Following Weaning From Incubator to Crib to Hospital Discharge (up to 120 Days)
[ Time Frame: From start of weaning from the incubator to crib through discharge (up to 120 days) ]

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).
2. Failure Rate of Weaning to Crib (Number of Infants With Axillary Temperature < 36.3°C After 2 Weaning Attempts)
[ Time Frame: Through completion of 2 weaning attempts ]

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.
3. Growth Velocity (Weight in Grams/kg/Day) From Start of Weaning From Incubator (Following Random Assignment) to 36 Weeks Postmenstrual Age (PMA)
[ Time Frame: Start of weaning from incubator through 36 weeks postmenstrual age (PMA) ]

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).
4. Growth Parameters: Weight at Status
[ Time Frame: Status (discharge, death, transfer to another facility, or 120 days) ]

Infant weight at status is measured at the time of discharge, death, transfer to another facility, or 120 days.
5. Growth Parameters: Length at Status
[ Time Frame: Status (discharge, death, transfer to another facility, or 120 days) ]

Infant length at status is measured at the time of discharge, death, transfer to another facility, or 120 days.
6. Growth Parameters: Head Circumference at Status
[ Time Frame: Status (discharge, death, transfer to another facility, or 120 days) ]

Infant head circumference at status is measured at the time of discharge, death, transfer to another facility, or 120 days.
7. Postmenstrual Age (PMA) at Discharge
[ Time Frame: Discharge ]

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.
8. Readmission to the Hospital Within 1 Week of Discharge
[ Time Frame: Discharge through 1 week after discharge. ]

Number of infants re-hospitalized within 1 week (7 days) of discharge.
9. Death Among Enrolled Infants
[ Time Frame: Status (discharge, death, transfer to another facility, or 120 days) ]

10. Transferred to a Non-Network Hospital
[ Time Frame: Status (discharge, death, transfer to another facility, or 120 days) ]

Number of infants transferred to another non-Network hospital.
11. Length of Stay (LOS) Following Randomization to Hospital Discharge
[ Time Frame: From randomization through discharge. ]

The number of days the infant stayed in hospital after randomization to the study until discharge.
Open or close this module Eligibility
Minimum Age: 29 Weeks
Maximum Age: 34 Weeks
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Gestational age 29 0/7 to 33 6/7 weeks at birth
  • Birth weight less than 1600 grams
  • Greater than 48 hours of age
  • Current weight less than 1540 grams
  • In an incubator

Exclusion Criteria:

  • Receiving phototherapy
  • Receiving respiratory support (including CPAP, ventilation, HFNC > 2 LPM)
  • Receiving blood pressure support
  • Designated for transfer to referral hospital while in incubator
  • Known major congenital or chromosomal anomaly
Open or close this module Contacts/Locations
Study Officials: Michele C Walsh, MD
Principal Investigator
Case Western Reserve University, Rainbow Babies and Children's Hospital
Myra Wyckoff, MD
Principal Investigator
University of Texas, Southwestern Medical Center at Dallas
Seetha Shankaran, MD
Study Chair
Wayne State University
David Carlton, MD
Principal Investigator
Emory University
Kurt Schibler, MD
Principal Investigator
Children's Hospital Medical Center, Cincinnati
Brenda B Poindexter, MD
Principal Investigator
Indiana University
Abbot Laptook, MD
Principal Investigator
Brown University, Women & Infants Hosptial of Rhode Island
Krisa P Van Meurs, MD
Principal Investigator
Stanford University
Waldemar Carlo, MD
Principal Investigator
University of Alabama at Birmingham
Kathleen A Kennedy, MD
Principal Investigator
The University of Texas Health Science Center, Houston
Mike Cotten, MD
Principal Investigator
Duke University
Edward F Bell, MD
Principal Investigator
University of Iowa
Kristi Watterberg, MD
Principal Investigator
University of New Mexico
Barbara Schmidt, MD
Principal Investigator
University of Pennsylvania
Carl T D'Angio, MD
Principal Investigator
University of Rochester
Uday Devaskar, MD
Principal Investigator
University of California, Los Angeles
Pablo Sanchez, MD
Principal Investigator
Research Institute at Nationwide Children's Hospital
William Truog, MD
Principal Investigator
Children's Mercy Hospital Kansas City
Abhik Das, PhD
Principal Investigator
RTI International
Locations: United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
United States, California
University of California - Los Angeles
Los Angeles, California, United States, 90025
Stanford University
Palo Alto, California, United States, 94304
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30303
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48201
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
United States, New York
University of Rochester
Rochester, New York, United States, 14642
United States, North Carolina
RTI International
Durham, North Carolina, United States, 27705
Duke University
Durham, North Carolina, United States, 27710
United States, Ohio
Cincinnati Children's Medical Center
Cincinnati, Ohio, United States, 45267
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Research Institute at Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
United States, Pennsylvania
Univeristy of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
Brown University, Women & Infants Hospital of Rhode Island
Providence, Rhode Island, United States, 02905
United States, Texas
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75235
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links: Description: NICHD Neonatal Research Network site
Description: NICHD Pregnancy & Perinatology Branch
Available IPD/Information:
Study Results
Open or close this module Participant Flow
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)
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
Open or close this module Baseline Characteristics
Arm/Group TitleLower Weight (1600 Grams)Higher Weight (1800 Grams)Total
Arm/Group DescriptionWeaning 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
Baseline Analysis Population Description
Age, Customized
Mean (Standard Deviation)
Unit of measure: weeks
Number Analyzed187 Participants179 Participants366 Participants
Gestational Age
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 Analyzed187 Participants179 Participants366 Participants
Female
93
49.73%
87
48.6%
180
49.18%
Male
94
50.27%
92
51.4%
186
50.82%
Race/Ethnicity, Customized
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed187 Participants179 Participants366 Participants
Black
76
40.64%
72
40.22%
148
40.44%
White
99
52.94%
97
54.19%
196
53.55%
Other
12
6.42%
10
5.59%
22
6.01%
Postmenstrual (PMA) age at start of weaning
Mean (Standard Deviation)
Unit of measure: weeks
Number Analyzed187 Participants179 Participants366 Participants
33.8(1.3)34.3(1.2)34.1(1.3)
Maternal Age
Mean (Standard Deviation)
Unit of measure: years
Number Analyzed187 Participants179 Participants366 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 Analyzed187 Participants179 Participants366 Participants
136122258
Open or close this module Outcome Measures
1. Primary Outcome:
Title Length of Hospital Stay (LOS) From Birth to Discharge (up to 120 Days)
Description Number of days the infant stays in hospital after birth until discharge home (up to 120 days).
Time Frame From birth through discharge
Outcome Measure Data
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 TitleLower Weight (1600 Grams)Higher Weight (1800 Grams)
Arm/Group DescriptionWeaning from an incubator at a lower weight (1600 grams)Weaning from an incubator at a higher weight (1800 grams)
Overall Number of Participants Analyzed185 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)
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)
Outcome Measure Data
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 TitleLower Weight (1600 Grams)Higher Weight (1800 Grams)
Arm/Group DescriptionWeaning from an incubator at a lower weight (1600 grams)Weaning from an incubator at a higher weight (1800 grams)
Overall Number of Participants Analyzed162 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)
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
Outcome Measure Data
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 TitleLower Weight (1600 Grams)Higher Weight (1800 Grams)
Arm/Group DescriptionWeaning from an incubator at a lower weight (1600 grams)Weaning from an incubator at a higher weight (1800 grams)
Overall Number of Participants Analyzed178 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)
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)
Outcome Measure Data
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 TitleLower Weight (1600 Grams)Higher Weight (1800 Grams)
Arm/Group DescriptionWeaning from an incubator at a lower weight (1600 grams)Weaning from an incubator at a higher weight (1800 grams)
Overall Number of Participants Analyzed119 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
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)
Outcome Measure Data
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 TitleLower Weight (1600 Grams)Higher Weight (1800 Grams)
Arm/Group DescriptionWeaning from an incubator at a lower weight (1600 grams)Weaning from an incubator at a higher weight (1800 grams)
Overall Number of Participants Analyzed185 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
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)
Outcome Measure Data
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 TitleLower Weight (1600 Grams)Higher Weight (1800 Grams)
Arm/Group DescriptionWeaning from an incubator at a lower weight (1600 grams)Weaning from an incubator at a higher weight (1800 grams)
Overall Number of Participants Analyzed174 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
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)
Outcome Measure Data
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 TitleLower Weight (1600 Grams)Higher Weight (1800 Grams)
Arm/Group DescriptionWeaning from an incubator at a lower weight (1600 grams)Weaning from an incubator at a higher weight (1800 grams)
Overall Number of Participants Analyzed182 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
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
Outcome Measure Data
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 TitleLower Weight (1600 Grams)Higher Weight (1800 Grams)
Arm/Group DescriptionWeaning from an incubator at a lower weight (1600 grams)Weaning from an incubator at a higher weight (1800 grams)
Overall Number of Participants Analyzed185 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
Description Number of infants re-hospitalized within 1 week (7 days) of discharge.
Time Frame Discharge through 1 week after discharge.
Outcome Measure Data
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 TitleLower Weight (1600 Grams)Higher Weight (1800 Grams)
Arm/Group DescriptionWeaning from an incubator at a lower weight (1600 grams)Weaning from an incubator at a higher weight (1800 grams)
Overall Number of Participants Analyzed174 168
Measure Type: Count of Participants
Unit of Measure: Participants
6
3.4%
2
1.2%
10. Secondary Outcome:
Title Death Among Enrolled Infants
Description
Time Frame Status (discharge, death, transfer to another facility, or 120 days)
Outcome Measure Data
Analysis Population Description
185 infants in the Lower Weight group and 178 infants in the Higher Weight group have status data.
 
Arm/Group TitleLower Weight (1600 Grams)Higher Weight (1800 Grams)
Arm/Group DescriptionWeaning from an incubator at a lower weight (1600 grams)Weaning from an incubator at a higher weight (1800 grams)
Overall Number of Participants Analyzed185 178
Measure Type: Count of Participants
Unit of Measure: Participants
0
0%
0
0%
11. Secondary Outcome:
Title Transferred to a Non-Network Hospital
Description Number of infants transferred to another non-Network hospital.
Time Frame Status (discharge, death, transfer to another facility, or 120 days)
Outcome Measure Data
Analysis Population Description
185 infants in the Lower Weight group and 178 infants in the Higher Weight group have status data.
 
Arm/Group TitleLower Weight (1600 Grams)Higher Weight (1800 Grams)
Arm/Group DescriptionWeaning from an incubator at a lower weight (1600 grams)Weaning from an incubator at a higher weight (1800 grams)
Overall Number of Participants Analyzed185 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
Description The number of days the infant stayed in hospital after randomization to the study until discharge.
Time Frame From randomization through discharge.
Outcome Measure Data
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 TitleLower Weight (1600 Grams)Higher Weight (1800 Grams)
Arm/Group DescriptionWeaning from an incubator at a lower weight (1600 grams)Weaning from an incubator at a higher weight (1800 grams)
Overall Number of Participants Analyzed185 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)
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)
Outcome Measure Data
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 TitleLower Weight (1600 Grams)Higher Weight (1800 Grams)
Arm/Group DescriptionWeaning from an incubator at a lower weight (1600 grams)Weaning from an incubator at a higher weight (1800 grams)
Overall Number of Participants Analyzed106 90
Mean (Standard Deviation)
Unit of Measure: grams/kilograms/day
11.0(7.4) 9.6(7.0)
Open or close this module Adverse Events
 
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)
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 (%)# Events Affected / At Risk (%)# Events
Total 0 / 187 (0%)0 / 179 (0%)
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%)
Gastrointestinal disorders
Pneumoperitoneum 1 / 187 (0.53%)10 / 179 (0%)0
Indicates events were collected by systematic assessment.
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%)32 / 179 (1.12%)3
Increasing heart failure 1 / 187 (0.53%)10 / 179 (0%)0
Tachycardia with desaturations 1 / 187 (0.53%)10 / 179 (0%)0
Gastrointestinal disorders
Feeding Intolerance 1 / 187 (0.53%)32 / 179 (1.12%)3
NEC IIa 1 / 187 (0.53%)10 / 179 (0%)0
Metabolism and nutrition disorders
Moderate cold stress 10 / 187 (5.35%)103 / 179 (1.68%)3
Severe cold stress 3 / 187 (1.6%)41 / 179 (0.56%)1
Respiratory, thoracic and mediastinal disorders
Desaturations 0 / 187 (0%)01 / 179 (0.56%)1
Respiratory distress 1 / 187 (0.53%)10 / 179 (0%)0
Indicates events were collected by systematic assessment.
Open or close this module Limitations and Caveats
[Not specified]
Open or close this module More Information
Certain Agreements:
Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between the Principal Investigator 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:
Name/Official Title:
Seetha Shankaran
Organization:
Wayne State University
Phone:
(313) 745-1436
Email:
sshankar@med.wayne.edu

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services