NCT02160002

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
366

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2015

Typical duration for not_applicable

Geographic Reach
1 country

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 10, 2014

Completed
8 months until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
7 months until next milestone

Results Posted

Study results publicly available

December 21, 2017

Completed
Last Updated

March 22, 2019

Status Verified

March 1, 2019

Enrollment Period

1.4 years

First QC Date

May 8, 2014

Results QC Date

November 28, 2017

Last Update Submit

March 20, 2019

Conditions

Infant, NewbornInfant, Moderate Preterm

Keywords

Incubator WeaningModerately Preterm InfantsGrowth Velocity

Outcome Measures

Primary Outcomes (1)

  • Length of Hospital Stay (LOS) From Birth to Discharge (up to 120 Days)

    Number of days the infant stays in hospital after birth until discharge home (up to 120 days).

    From birth through discharge

Secondary Outcomes (11)

  • Length of Stay (LOS) Following Weaning From Incubator to Crib to Hospital Discharge (up to 120 Days)

    From start of weaning from the incubator to crib through discharge (up to 120 days)

  • Failure Rate of Weaning to Crib (Number of Infants With Axillary Temperature < 36.3°C After 2 Weaning Attempts)

    Through completion of 2 weaning attempts

  • Growth Velocity (Weight in Grams/kg/Day) From Start of Weaning From Incubator (Following Random Assignment) to 36 Weeks Postmenstrual Age (PMA)

    Start of weaning from incubator through 36 weeks postmenstrual age (PMA)

  • Growth Parameters: Weight at Status

    Status (discharge, death, transfer to another facility, or 120 days)

  • Growth Parameters: Length at Status

    Status (discharge, death, transfer to another facility, or 120 days)

  • +6 more secondary outcomes

Study Arms (2)

Lower Weight (1600 grams)

ACTIVE COMPARATOR

Weaning from an incubator at a lower weight (1600 grams)

Procedure: Weaning from an incubator at a lower weight (1600 grams)

Higher Weight (1800 grams)

ACTIVE COMPARATOR

Weaning from an incubator at a higher weight (1800 grams)

Procedure: Weaning from an incubator at a higher weight (1800 grams)

Interventions

Weaning from an incubator at a lower weight (1600 grams)PROCEDURE

Infants will be weaned from an incubator at a lower weight (1600 grams)

Lower Weight (1600 grams)
Weaning from an incubator at a higher weight (1800 grams)PROCEDURE

Infants will be weaned from an incubator at a higher weight (1800 grams)

Higher Weight (1800 grams)

Eligibility Criteria

Age29 Weeks - 34 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

University of California - Los Angeles

Los Angeles, California, 90025, United States

Location

Stanford University

Palo Alto, California, 94304, United States

Location

Emory University

Atlanta, Georgia, 30303, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

RTI International

Durham, North Carolina, 27705, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Cincinnati Children's Medical Center

Cincinnati, Ohio, 45267, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Research Institute at Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Univeristy of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Brown University, Women & Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

Location

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75235, United States

Location

Related Publications (2)

  • Chowdhary V, Shukla A. Weaning of moderately preterm infants from the incubator to the crib: a randomized clinical trial. Acta Paediatr. 2019 Jul;108(7):1364. doi: 10.1111/apa.14774. Epub 2019 Apr 29. No abstract available.

    PMID: 31033050DERIVED

  • Shankaran S, Bell EF, Laptook AR, Saha S, Newman NS, Kazzi SNJ, Barks J, Stoll BJ, Bara R, Gabrio J, Childs K, Das A, Higgins RD, Carlo WA, Sanchez PJ, Carlton DP, Pavageau L, Malcolm WF, D'Angio CT, Ohls RK, Poindexter BB, Sokol GM, Van Meurs KP, Colaizy TT, Khmour A, Puopolo KM, Garg M, Walsh MC; Eunice Kennedy Shriver National Institute of Child Health, and Human Development Neonatal Research Network. Weaning of Moderately Preterm Infants from the Incubator to the Crib: A Randomized Clinical Trial. J Pediatr. 2019 Jan;204:96-102.e4. doi: 10.1016/j.jpeds.2018.08.079. Epub 2018 Oct 15.

    PMID: 30337189DERIVED

Related Links

Results Point of Contact

Title
Seetha Shankaran
Organization
Wayne State University
sshankar@med.wayne.edu
(313) 745-1436

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

  • Seetha Shankaran, MD

    Wayne State University

    STUDY CHAIR

  • 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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2014

First Posted

June 10, 2014

Study Start

February 1, 2015

Primary Completion

July 1, 2016

Study Completion

June 1, 2017

Last Updated

March 22, 2019

Results First Posted

December 21, 2017

Record last verified: 2019-03

Locations

US(18)