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Incubator Weaning of Moderately Preterm Infants

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: 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 Description
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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.


Condition or disease Intervention/treatment Phase
Infant, Newborn Infant, Moderate Preterm Procedure: Weaning from an incubator at a lower weight (1600 grams) Procedure: Weaning from an incubator at a higher weight (1800 grams) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 366 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Incubator Weaning of Moderately Preterm Infants: A Randomized Controlled Trial
Actual Study Start Date : February 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arms and Interventions
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Arm Intervention/treatment
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)


Outcome Measures
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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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   29 Weeks to 34 Weeks   (Child)
Sexes Eligible for Study:   All
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02160002


Locations
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Sponsors and Collaborators
NICHD Neonatal Research Network
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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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
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: NICHD Neonatal Research Network
ClinicalTrials.gov Identifier: NCT02160002    
Other Study ID Numbers: NICHD-NRN-0054
First Posted: June 10, 2014    Key Record Dates
Results First Posted: December 21, 2017
Last Update Posted: March 22, 2019
Last Verified: March 2019
Keywords provided by NICHD Neonatal Research Network:
Incubator Weaning
Moderately Preterm Infants
Growth Velocity
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
 Pregnancy Complications
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases