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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
Health authority
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

Study Design


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
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