Study Results
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View full resultsBasic Information
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COMPLETED
NA
366 participants
INTERVENTIONAL
2015-02-28
2017-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Lower Weight (1600 grams)
Weaning from an incubator at a lower weight (1600 grams)
Weaning from an incubator at a lower weight (1600 grams)
Infants will be weaned from an incubator at a lower weight (1600 grams)
Higher Weight (1800 grams)
Weaning from an incubator at a higher weight (1800 grams)
Weaning from an incubator at a higher weight (1800 grams)
Infants will be weaned from an incubator at a higher weight (1800 grams)
Interventions
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Weaning from an incubator at a lower weight (1600 grams)
Infants will be weaned from an incubator at a lower weight (1600 grams)
Weaning from an incubator at a higher weight (1800 grams)
Infants will be weaned from an incubator at a higher weight (1800 grams)
Eligibility Criteria
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Inclusion Criteria
* Birth weight less than 1600 grams
* Greater than 48 hours of age
* Current weight less than 1540 grams
* In an incubator
Exclusion Criteria
* 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
29 Weeks
34 Weeks
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
NICHD Neonatal Research Network
NETWORK
Responsible Party
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Principal Investigators
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Michele C Walsh, MD
Role: PRINCIPAL_INVESTIGATOR
Case Western Reserve University, Rainbow Babies and Children's Hospital
Myra Wyckoff, MD
Role: PRINCIPAL_INVESTIGATOR
University of Texas, Southwestern Medical Center at Dallas
Seetha Shankaran, MD
Role: STUDY_CHAIR
Wayne State University
David Carlton, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Kurt Schibler, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Brenda B Poindexter, MD
Role: PRINCIPAL_INVESTIGATOR
Indiana University
Abbot Laptook, MD
Role: PRINCIPAL_INVESTIGATOR
Brown University, Women & Infants Hosptial of Rhode Island
Krisa P Van Meurs, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Waldemar Carlo, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Kathleen A Kennedy, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Mike Cotten, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Edward F Bell, MD
Role: PRINCIPAL_INVESTIGATOR
University of Iowa
Kristi Watterberg, MD
Role: PRINCIPAL_INVESTIGATOR
University of New Mexico
Barbara Schmidt, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Carl T D'Angio, MD
Role: PRINCIPAL_INVESTIGATOR
University of Rochester
Uday Devaskar, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Pablo Sanchez, MD
Role: PRINCIPAL_INVESTIGATOR
Research Institute at Nationwide Children's Hospital
William Truog, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Mercy Hospital Kansas City
Abhik Das, PhD
Role: PRINCIPAL_INVESTIGATOR
RTI International
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of California - Los Angeles
Los Angeles, California, United States
Stanford University
Palo Alto, California, United States
Emory University
Atlanta, Georgia, United States
Indiana University
Indianapolis, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
Wayne State University
Detroit, Michigan, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
University of New Mexico
Albuquerque, New Mexico, United States
University of Rochester
Rochester, New York, United States
RTI International
Durham, North Carolina, United States
Duke University
Durham, North Carolina, United States
Cincinnati Children's Medical Center
Cincinnati, Ohio, United States
Case Western Reserve University
Cleveland, Ohio, United States
Research Institute at Nationwide Children's Hospital
Columbus, Ohio, United States
Univeristy of Pennsylvania
Philadelphia, Pennsylvania, United States
Brown University, Women & Infants Hospital of Rhode Island
Providence, Rhode Island, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States
Countries
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References
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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.
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.
Related Links
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NICHD Neonatal Research Network site
NICHD Pregnancy \& Perinatology Branch
Other Identifiers
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NICHD-NRN-0054
Identifier Type: -
Identifier Source: org_study_id
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