Physiologic Definition of Bronchopulmonary Dysplasia

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Brief Title

Physiologic Definition of Bronchopulmonary Dysplasia

Official Title

Physiologic Definition of Bronchopulmonary Dysplasia

Brief 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).
    

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


Primary Outcome

Bronchopulmonary dysplasia


Condition

Infant, Newborn



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

410

Start Date

May 2005

Completion Date

September 2008

Primary Completion Date

May 2008

Eligibility 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
      

Gender

All

Ages

36 Weeks - 37 Weeks

Accepts Healthy Volunteers

No

Contacts

Michele C. Walsh, MD MS, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01223287

Organization ID

NICHD-NRN-0032

Secondary IDs

U10HD027904

Responsible Party

Sponsor

Study Sponsor

NICHD Neonatal Research Network

Collaborators

 National Center for Research Resources (NCRR)

Study Sponsor

Michele C. Walsh, MD MS, Principal Investigator, Case Western Reserve University, Rainbow Babies & Children's Hospital


Verification Date

September 2017