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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

Tracking Information
First Submitted Date  ICMJE May 8, 2014
First Posted Date  ICMJE June 10, 2014
Results First Submitted Date  ICMJE November 28, 2017
Results First Posted Date  ICMJE December 21, 2017
Last Update Posted Date March 22, 2019
Actual Study Start Date  ICMJE February 2015
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2017)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: June 6, 2014)
Length of Hospital Stay (LOS) From Birth to Discharge [ Time Frame: Participants will be followed until discharge, which could be up to 80 days. ]
The primary outcome is length of hospital stay (LOS) from birth to discharge. We have selected LOS as a decrease in LOS will have potential economic and family benefits.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2017)
  • 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).
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Death Among Enrolled Infants [ Time Frame: Status (discharge, death, transfer to another facility, or 120 days) ]
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2014)
  • Length of stay following weaning from incubator to crib to hospital discharge [ Time Frame: Participants will be followed until discharge, which could be up to 80 days. ]
  • Failure rate of weaning to crib (proportion of infants with axillary temperature < = 36.3°C after 2 weaning attempts) [ Time Frame: Participants will be followed for the duration of hospital stay, which could be up to 80 days. ]
  • Growth velocity (weight in grams/kg/day) following random assignment to 36 weeks post menstrual age [ Time Frame: 36 weeks post menstrual age ]
  • Growth parameters and postmenstrual age at discharge [ Time Frame: Participants will be followed until discharge, which could be up to 80 days. ]
    Discharge growth parameters (weight, length and head circumference) will be obtained from infants transferred to another institution after enrollment.
  • Readmission to the Hospital Within 1 Week of Discharge [ Time Frame: From birth up to 87 days. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Incubator Weaning of Moderately Preterm Infants
Official Title  ICMJE Incubator Weaning of Moderately Preterm Infants: A Randomized Controlled Trial
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Infant, Newborn
  • Infant, Moderate Preterm
Intervention  ICMJE
  • Procedure: Weaning from an incubator at a lower weight (1600 grams)
    Infants will be weaned from an incubator at a lower weight (1600 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)
Study Arms  ICMJE
  • Active Comparator: Lower Weight (1600 grams)
    Weaning from an incubator at a lower weight (1600 grams)
    Intervention: Procedure: Weaning 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)
    Intervention: Procedure: Weaning from an incubator at a higher weight (1800 grams)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 6, 2014)
366
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2017
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 29 Weeks to 34 Weeks   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02160002
Other Study ID Numbers  ICMJE NICHD-NRN-0054
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NICHD Neonatal Research Network
Study Sponsor  ICMJE NICHD Neonatal Research Network
Collaborators  ICMJE Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators  ICMJE
Principal Investigator: Michele C Walsh, MD Case Western Reserve University, Rainbow Babies and Children's Hospital
Principal Investigator: Myra Wyckoff, MD University of Texas, Southwestern Medical Center at Dallas
Study Chair: Seetha Shankaran, MD Wayne State University
Principal Investigator: David Carlton, MD Emory University
Principal Investigator: Kurt Schibler, MD Children's Hospital Medical Center, Cincinnati
Principal Investigator: Brenda B Poindexter, MD Indiana University
Principal Investigator: Abbot Laptook, MD Brown University, Women & Infants Hosptial of Rhode Island
Principal Investigator: Krisa P Van Meurs, MD Stanford University
Principal Investigator: Waldemar Carlo, MD University of Alabama at Birmingham
Principal Investigator: Kathleen A Kennedy, MD The University of Texas Health Science Center, Houston
Principal Investigator: Mike Cotten, MD Duke University
Principal Investigator: Edward F Bell, MD University of Iowa
Principal Investigator: Kristi Watterberg, MD University of New Mexico
Principal Investigator: Barbara Schmidt, MD University of Pennsylvania
Principal Investigator: Carl T D'Angio, MD University of Rochester
Principal Investigator: Uday Devaskar, MD University of California, Los Angeles
Principal Investigator: Pablo Sanchez, MD Research Institute at Nationwide Children's Hospital
Principal Investigator: William Truog, MD Children's Mercy Hospital Kansas City
Principal Investigator: Abhik Das, PhD RTI International
PRS Account NICHD Neonatal Research Network
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP