Physiologic Definition of Bronchopulmonary Dysplasia

NCT01223287 | Completed

• 43 other identifiers: NICHD-NRN-0032U10HD027904U10HD021364M01RR000080U10HD027853M01RR008084U10HD040492M01RR000030U10HD027851M01RR000039UL1RR025008U10HD027856M01RR000750UL1RR025761U10HD027880M01RR000070UL1RR025744U10HD053119M01RR000054U10HD034216M01RR000032U10HD040461U10HD053109M01RR000059UL1RR024979U10HD021397M01RR016587U10HD053089M01RR000997U10HD040521M01RR000044UL1RR024160U10HD053124M01RR000064UL1RR025764U10HD040689M01RR000633U10HD021373U10HD040498M01RR007122U10HD021385U10HD027871UL1RR024139
• Study Type: observational
• Target: 410
• Locations: 1 country
• Sites: 21

Brief Summary

This observational study was conducted to design and test a physiologic definition for bronchopulmonary dysplasia at 36 weeks of life. Infants were studied in a supine position with the pulse oximeter in position with good signal prior to collecting baseline data. Feedings and medications were given 30 minutes before the evaluation. Baseline data was collected on infant's current oxygen. Then, the infants were weaned to room air for 30 minutes. If saturations remain ≥90%, the infant was considered to have passed the oxygen reduction challenge (to NOT have BPD). The infant should then be placed back in his/her baseline oxygen. If the infant has saturations \<90% for 5 continuous minutes or \<80% for 15 seconds, the infant should be immediately placed back in his/her baseline oxygen, and the infant was considered to have NOT passed the challenge (to have BPD).

Conditions

Infant, Newborn; Infant, Low Birth Weight; Infant, Small for Gestational Age; Infant, Premature; Bronchopulmonary Dysplasia (BPD)

Keywords

NICHD Neonatal Research Network; Extremely Low Birth Weight (ELBW); Very Low Birth Weight (VLBW); Prematurity; Mechanical ventilation; Chronic Lung Disease (CLD)

Outcome Measures

Primary Outcomes (1)

• Bronchopulmonary dysplasia

  36 weeks of life

Eligibility Criteria

• Age: 36 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Premature infants on mechanical ventilation at 36 weeks of life.

You may qualify if:

• Infant with birthweight 401-1500 grams
• Alive at 36+1 week corrected age
• On supplemental oxygen as follows:
• A. Infants receiving oxygen by hood at rest:
• A1. Oxygen by hood \<27% with majority\* of saturations ≥ 90% in prior 24 hours.
• A2. Oxygen by hood 27-30% with majority\* of saturations ≥ 96% in prior 24 hours
• B. Infants receiving oxygen by nasal cannula at restΔ:
• B1. Oxygen by nasal cannula \<27% EFFECTIVE\*\* oxygen and majority\* of saturations ≥90% in prior 24 hours.
• B2. Oxygen by nasal cannula 27-30% EFFECTIVE\*\* oxygen and majority\* saturations ≥96% on prior 24 hours.
• C. Infants receiving room air by nasal cannula at ANY liter per minute (lpm) flow.

You may not qualify if:

• Need for mechanical ventilation or continuous positive airway pressure (CPAP)
• Oxygen by hood \>30%
• Oxygen by nasal cannula \>30% effective oxygen

Sponsors & Collaborators

• NICHD Neonatal Research Network: lead
• National Center for Research Resources (NCRR): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (21)

University of Alabama

Birmingham, Alabama, 35249-7335, United States

Location

Stanford University

Palo Alto, California, 94304, United States

Location

University of California at San Diego

San Diego, California, 92103-8774, United States

Location

Yale University

New Haven, Connecticut, 06504, United States

Location

University of Miami

Miami, Florida, 33136, 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

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Wake Forest University

Charlotte, North Carolina, 27157, 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, Rainbow Babies and Children's Hospital

Cleveland, Ohio, 44106, 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

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

University of Utah

Salt Lake City, Utah, 84108, United States

Location

Related Publications (1)

• Walsh MC, Yao Q, Gettner P, Hale E, Collins M, Hensman A, Everette R, Peters N, Miller N, Muran G, Auten K, Newman N, Rowan G, Grisby C, Arnell K, Miller L, Ball B, McDavid G; National Institute of Child Health and Human Development Neonatal Research Network. Impact of a physiologic definition on bronchopulmonary dysplasia rates. Pediatrics. 2004 Nov;114(5):1305-11. doi: 10.1542/peds.2004-0204.

  PMID: 15520112 BACKGROUND

Related Links

• NICHD Neonatal Research Network

MeSH Terms

Conditions

Premature Birth; Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Michele C. Walsh, MD MS

  Case Western Reserve University, Rainbow Babies & Children's Hospital

  PRINCIPAL INVESTIGATOR

• Abbot R. Laptook, MD

  Brown University, Women & Infants Hospital of Rhode Island

  PRINCIPAL INVESTIGATOR

• Kurt Schibler, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

• Ronald N. Goldberg, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Barbara J. Stoll, MD

  Emory University

  PRINCIPAL INVESTIGATOR

• Brenda B. Poindexter, MD MS

  Indiana University

  PRINCIPAL INVESTIGATOR

• Krisa P. Van Meurs, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Ivan D. Franz, III, MD

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

• Waldemar A. Carlo, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

• Neil N. Finer, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

• Edward F. Bell, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

• Charles R. Bauer, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

• Kristi L. Watterberg, MD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

• Dale L. Phelps, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

• Roger G. Faix, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

• Pablo J. Sanchez, MD

  University of Texas, Southwestern Medical Center at Dallas

  PRINCIPAL INVESTIGATOR

• Kathleen A. Kennedy, MD MPH

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

• T. Michael O'Shea, MD MPH

  Wake Forest University

  PRINCIPAL INVESTIGATOR

• Seetha Shankaran, MD

  Wayne State University

  PRINCIPAL INVESTIGATOR

• Richard A. Ehrenkranz, MD

  Yale University

  PRINCIPAL INVESTIGATOR

• Abhik Das, PhD

  RTI International

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2010
• First Posted: October 18, 2010
• Study Start: May 1, 2005
• Primary Completion: May 1, 2008
• Study Completion: September 1, 2008
• Last Updated: September 26, 2017

Record last verified: 2017-09

Locations

US (21)