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Incubator Weaning of Moderately Preterm Infants

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
NICHD Neonatal Research Network
ClinicalTrials.gov Identifier:
NCT02160002
First received: May 8, 2014
Last updated: May 9, 2017
Last verified: May 2017
  Purpose

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 Intervention
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)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Incubator Weaning of Moderately Preterm Infants: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by NICHD Neonatal Research Network:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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. ]

Enrollment: 366
Study Start Date: February 2015
Estimated Study Completion Date: June 2017
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
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)

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02160002

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

Additional Information:
Responsible Party: NICHD Neonatal Research Network
ClinicalTrials.gov Identifier: NCT02160002     History of Changes
Other Study ID Numbers: NICHD-NRN-0054
Study First Received: May 8, 2014
Last Updated: May 9, 2017

Keywords provided by NICHD Neonatal Research Network:
Incubator Weaning
Moderately Preterm Infants
Growth Velocity

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on May 22, 2017