Physiologic Definition of Bronchopulmonary Dysplasia (PhysiologicDef)

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).

Study Overview

• Status: Completed
• Conditions: Bronchopulmonary Dysplasia (BPD); Infant, Small for Gestational Age; Infant, Premature; Infant, Low Birth Weight; Infant, Newborn

Detailed Description

One of the confounders to any study that looks at bronchopulmonary dysplasia (BPD) is the lack of a precise definition. Most neonates with BPD do not undergo lung biopsy or any physiologic test; thus, their pulmonary disease is defined clinically, on the basis of the sustained need for supplemental oxygen at 36 weeks postmenstrual age. The validity of this definition is supported by evidence that oxygen dependence at 36 weeks is predictive of long-term impairment in pulmonary function. An inherent limitation of defining BPD by the need for supplemental oxygen is that the need for oxygen is determined by individual physicians, rather than on the basis of a physiologic assessment. Published literature cites acceptable saturation ranges from 88-98%.

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).

• Study Type: Observational
• Enrollment (Actual): 410

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35249-7335
      • University of Alabama
  • California
    • Palo Alto, California, United States, 94304
      • Stanford University
    • San Diego, California, United States, 92103-8774
      • University of California at San Diego
  • Connecticut
    • New Haven, Connecticut, United States, 06504
      • Yale University
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Emory University
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Wayne State University
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • University of New Mexico
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester
  • North Carolina
    • Charlotte, North Carolina, United States, 27157
      • Wake Forest University
    • Durham, North Carolina, United States, 27710
      • Duke University
    • Durham, North Carolina, United States, 27705
      • RTI International
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • Cincinnati Children's Medical Center
    • Cleveland, Ohio, United States, 44106
      • Case Western Reserve University, Rainbow Babies and Children's Hospital
  • Rhode Island
    • Providence, Rhode Island, United States, 02905
      • Brown University, Women & Infants Hospital of Rhode Island
  • Texas
    • Dallas, Texas, United States, 75235
      • University of Texas Southwestern Medical Center at Dallas
    • Houston, Texas, United States, 77030
      • University of Texas Health Science Center at Houston
  • Utah
    • Salt Lake City, Utah, United States, 84108
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 months to 8 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Premature infants on mechanical ventilation at 36 weeks of life.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Bronchopulmonary dysplasia	36 weeks of life

Collaborators and Investigators

• Sponsor: NICHD Neonatal Research Network
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Center for Research Resources (NCRR)
• Investigators: Principal Investigator: Michele C. Walsh, MD MS, Case Western Reserve University, Rainbow Babies & Children's Hospital; Principal Investigator: Ivan D. Franz, III, MD, Tufts Medical Center

Publications and helpful links

General Publications

• 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.

Helpful Links

• NICHD Neonatal Research Network

Study record dates

Study Major Dates

• Study Start: May 1, 2005
• Primary Completion (Actual): May 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: October 14, 2010
• First Submitted That Met QC Criteria: October 14, 2010
• First Posted (Estimate): October 18, 2010

Study Record Updates

• Last Update Posted (Actual): September 26, 2017
• Last Update Submitted That Met QC Criteria: September 22, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Prematurity; Mechanical ventilation; NICHD Neonatal Research Network; Very Low Birth Weight (VLBW); Extremely Low Birth Weight (ELBW); Chronic Lung Disease (CLD)
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Body Weight; Lung Injury; Infant, Premature, Diseases; Ventilator-Induced Lung Injury; Birth Weight; Bronchopulmonary Dysplasia
• Other Study ID Numbers: NICHD-NRN-0032; M01RR000633 (U.S. NIH Grant/Contract); U10HD021364 (U.S. NIH Grant/Contract); U10HD021373 (U.S. NIH Grant/Contract); U10HD021385 (U.S. NIH Grant/Contract); U10HD027851 (U.S. NIH Grant/Contract); U10HD027853 (U.S. NIH Grant/Contract); U10HD027856 (U.S. NIH Grant/Contract); U10HD027871 (U.S. NIH Grant/Contract); U10HD027880 (U.S. NIH Grant/Contract); U10HD027904 (U.S. NIH Grant/Contract); U10HD034216 (U.S. NIH Grant/Contract); U10HD040492 (U.S. NIH Grant/Contract); U10HD040689 (U.S. NIH Grant/Contract); U10HD053089 (U.S. NIH Grant/Contract); U10HD053109 (U.S. NIH Grant/Contract); U10HD053119 (U.S. NIH Grant/Contract); U10HD053124 (U.S. NIH Grant/Contract); UL1RR024139 (U.S. NIH Grant/Contract); UL1RR025744 (U.S. NIH Grant/Contract); UL1RR024979 (U.S. NIH Grant/Contract); M01RR000059 (U.S. NIH Grant/Contract); M01RR008084 (U.S. NIH Grant/Contract); M01RR000750 (U.S. NIH Grant/Contract); M01RR000070 (U.S. NIH Grant/Contract); M01RR000997 (U.S. NIH Grant/Contract); U10HD021397 (U.S. NIH Grant/Contract); U10HD040461 (U.S. NIH Grant/Contract); U10HD040498 (U.S. NIH Grant/Contract); U10HD040521 (U.S. NIH Grant/Contract); M01RR000032 (U.S. NIH Grant/Contract); M01RR000039 (U.S. NIH Grant/Contract); M01RR000044 (U.S. NIH Grant/Contract); M01RR000054 (U.S. NIH Grant/Contract); M01RR000064 (U.S. NIH Grant/Contract); M01RR000080 (U.S. NIH Grant/Contract); M01RR007122 (U.S. NIH Grant/Contract); M01RR016587 (U.S. NIH Grant/Contract); UL1RR025764 (U.S. NIH Grant/Contract); UL1RR025008 (U.S. NIH Grant/Contract); M01RR000030 (U.S. NIH Grant/Contract); UL1RR025761 (U.S. NIH Grant/Contract); UL1RR024160 (U.S. NIH Grant/Contract)