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Physiologic Definition of Bronchopulmonary Dysplasia (PhysiologicDef)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01223287
First Posted: October 18, 2010
Last Update Posted: September 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Center for Research Resources (NCRR)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
NICHD Neonatal Research Network
  Purpose
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).

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Physiologic Definition of Bronchopulmonary Dysplasia

Resource links provided by NLM:


Further study details as provided by NICHD Neonatal Research Network:

Primary Outcome Measures:
  • Bronchopulmonary dysplasia [ Time Frame: 36 weeks of life ]

Enrollment: 410
Study Start Date: May 2005
Study Completion Date: September 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
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).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   36 Weeks to 37 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Premature infants on mechanical ventilation at 36 weeks of life.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01223287


  Show 21 Study Locations
Sponsors and Collaborators
NICHD Neonatal Research Network
National Center for Research Resources (NCRR)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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 University
Principal Investigator: Seetha Shankaran, MD Wayne State University
Principal Investigator: Richard A. Ehrenkranz, MD Yale University
Principal Investigator: Abhik Das, PhD RTI International
  More Information

Additional Information:
Publications:
Responsible Party: NICHD Neonatal Research Network
ClinicalTrials.gov Identifier: NCT01223287     History of Changes
Other Study ID Numbers: NICHD-NRN-0032
U10HD027904 ( U.S. NIH Grant/Contract )
U10HD021364 ( U.S. NIH Grant/Contract )
M01RR000080 ( U.S. NIH Grant/Contract )
U10HD027853 ( U.S. NIH Grant/Contract )
M01RR008084 ( U.S. NIH Grant/Contract )
U10HD040492 ( U.S. NIH Grant/Contract )
M01RR000030 ( U.S. NIH Grant/Contract )
U10HD027851 ( U.S. NIH Grant/Contract )
M01RR000039 ( U.S. NIH Grant/Contract )
UL1RR025008 ( U.S. NIH Grant/Contract )
U10HD027856 ( U.S. NIH Grant/Contract )
M01RR000750 ( U.S. NIH Grant/Contract )
UL1RR025761 ( U.S. NIH Grant/Contract )
U10HD027880 ( U.S. NIH Grant/Contract )
M01RR000070 ( U.S. NIH Grant/Contract )
UL1RR025744 ( U.S. NIH Grant/Contract )
U10HD053119 ( U.S. NIH Grant/Contract )
M01RR000054 ( U.S. NIH Grant/Contract )
U10HD034216 ( U.S. NIH Grant/Contract )
M01RR000032 ( U.S. NIH Grant/Contract )
U10HD040461 ( U.S. NIH Grant/Contract )
U10HD053109 ( U.S. NIH Grant/Contract )
M01RR000059 ( U.S. NIH Grant/Contract )
UL1RR024979 ( U.S. NIH Grant/Contract )
U10HD021397 ( U.S. NIH Grant/Contract )
M01RR016587 ( U.S. NIH Grant/Contract )
U10HD053089 ( U.S. NIH Grant/Contract )
M01RR000997 ( U.S. NIH Grant/Contract )
U10HD040521 ( U.S. NIH Grant/Contract )
M01RR000044 ( U.S. NIH Grant/Contract )
UL1RR024160 ( U.S. NIH Grant/Contract )
U10HD053124 ( U.S. NIH Grant/Contract )
M01RR000064 ( U.S. NIH Grant/Contract )
UL1RR025764 ( U.S. NIH Grant/Contract )
U10HD040689 ( U.S. NIH Grant/Contract )
M01RR000633 ( U.S. NIH Grant/Contract )
U10HD021373 ( U.S. NIH Grant/Contract )
U10HD040498 ( U.S. NIH Grant/Contract )
M01RR007122 ( U.S. NIH Grant/Contract )
U10HD021385 ( U.S. NIH Grant/Contract )
U10HD027871 ( U.S. NIH Grant/Contract )
UL1RR024139 ( U.S. NIH Grant/Contract )
First Submitted: October 14, 2010
First Posted: October 18, 2010
Last Update Posted: September 26, 2017
Last Verified: September 2017

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

Additional relevant MeSH terms:
Birth Weight
Bronchopulmonary Dysplasia
Body Weight
Signs and Symptoms
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases