Physiologic Definition of Bronchopulmonary Dysplasia

Infant, Premature Clinical Trial

— PhysiologicDef  

Official title:

Physiologic Definition of Bronchopulmonary Dysplasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01223287
• Other study ID #: NICHD-NRN-0032
• Secondary ID: U10HD027904U10HD
• Status: Completed
• Phase: N/A
• First received: October 14, 2010
• Last updated: September 22, 2017
• Start date: May 2005
• Est. completion date: September 2008

Study information

• Verified date: September 2017
• Source: NICHD Neonatal Research Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 410
• Est. completion date: September 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 36 Weeks to 37 Weeks

Eligibility

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 rest?:

• 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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	University of New Mexico	Albuquerque	New Mexico
United States	Emory University	Atlanta	Georgia
United States	University of Alabama	Birmingham	Alabama
United States	Tufts Medical Center	Boston	Massachusetts
United States	Wake Forest University	Charlotte	North Carolina
United States	Cincinnati Children's Medical Center	Cincinnati	Ohio
United States	Case Western Reserve University, Rainbow Babies and Children's Hospital	Cleveland	Ohio
United States	University of Texas Southwestern Medical Center at Dallas	Dallas	Texas
United States	Wayne State University	Detroit	Michigan
United States	Duke University	Durham	North Carolina
United States	RTI International	Durham	North Carolina
United States	University of Texas Health Science Center at Houston	Houston	Texas
United States	Indiana University	Indianapolis	Indiana
United States	University of Iowa	Iowa City	Iowa
United States	University of Miami	Miami	Florida
United States	Yale University	New Haven	Connecticut
United States	Stanford University	Palo Alto	California
United States	Brown University, Women & Infants Hospital of Rhode Island	Providence	Rhode Island
United States	University of Rochester	Rochester	New York
United States	University of Utah	Salt Lake City	Utah
United States	University of California at San Diego	San Diego	California

Sponsors (3)

Lead Sponsor	Collaborator
NICHD Neonatal Research Network	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bronchopulmonary dysplasia		36 weeks of life

External Links

•   NICHD Neonatal Research Network