Physiologic Definition of Bronchopulmonary Dysplasia (PhysiologicDef)

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT01223287
First received: October 14, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted

October 14, 2010
October 14, 2010
May 2005
May 2008   (final data collection date for primary outcome measure)
Bronchopulmonary dysplasia [ Time Frame: 36 weeks of life ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
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Physiologic Definition of Bronchopulmonary Dysplasia
Physiologic Definition of Bronchopulmonary Dysplasia

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).

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).

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

Premature infants on mechanical ventilation at 36 weeks of life.

  • Infant, Newborn
  • Infant, Low Birth Weight
  • Infant, Small for Gestational Age
  • Infant, Premature
  • Bronchopulmonary Dysplasia (BPD)
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Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
410
September 2008
May 2008   (final data collection date for primary outcome measure)

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
Both
36 Weeks to 37 Weeks
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01223287
NICHD-NRN-0032, U10HD027904, U10HD021364, M01RR000080, U10HD027853, M01RR008084, U10HD040492, M01RR000030, U10HD027851, M01RR000039, UL1RR025008, U10HD027856, M01RR000750, UL1RR025761, U10HD027880, M01RR000070, UL1RR025744, U10HD053119, M01RR000054, U10HD034216, M01RR000032, U10HD040461, U10HD053109, M01RR000059, UL1RR024979, U10HD021397, M01RR016587, U10HD053089, M01RR000997, U10HD040521, M01RR000044, UL1RR024160, U10HD053124, M01RR000064, UL1RR025764, U10HD040689, M01RR000633, U10HD021373, U10HD040498, M01RR007122, U10HD021385, U10HD027871, UL1RR024139
No
Michele C. Walsh, Lead Principal Investigator, Case Western Reserve University, Rainbow Babies & Children's Hospital
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Center for Research Resources (NCRR)
Principal Investigator: 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 School of Medicine
Principal Investigator: Seetha Shankaran, MD Wayne State University
Principal Investigator: Richard A. Ehrenkranz, MD Yale University
Principal Investigator: Abhik Das, PhD RTI International
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP