Antecedents of Bronchopulmonary Dysplasia

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Brief Title

Antecedents of Bronchopulmonary Dysplasia


Brief Summary

      To identify risk factors for bronchopulmonary dysplasia/chronic pulmonary disease of
      prematurity and to estimate proportions of this group of disorders attributable to antenatal
      risk factors, perinatal events, and neonatal care procedures.
    

Detailed Description

      BACKGROUND:

      The Phenobarbital Prophylaxis for Neonatal Intracranial Hemorrhage Study was a clinical trial
      supported by the National Institute of Neurological and Communicative Disorders and Stroke
      (NINCDS), and enrolled 280 infants at three Harvard Neonatal Intensive Care Units between
      June 1981 and April 1984. Babies were recruited for the study if their birth weights were
      1,750 grams or less, they had no demonstrable intraventricular hemorrhage by cranial
      ultrasound and they required intubation within the first twelve hours of life. Data collected
      included maternal history, infant health status, and events of hospitalization.

      The Antenatal Risk Factors for Intraventricular Hemorrhage Study, also funded by NINCDS, was
      composed of 520 infants, at or less than 1,500 grams birth weight who were born at two
      Harvard teaching hospitals between July 1984 and September 1986. Babies were enrolled if they
      were alive when their mothers were interviewed, usually 24-48 hours after delivery.
      Procedures in the delivery room and findings on early examinations were recorded. Information
      about the first five days of life was collected daily.

      Bronchopulmonary dysplasia/chronic pulmonary disease of prematurity is a substantial
      long-term problem in survivors of neonatal intensive care. This disorder is seen in 15 to 35
      percent of surviving infants whose birth weight was less than 1,500 grams. It is estimated
      that 5 percent of all neonatal intensive care unit admissions develop the affliction.
      Affected infants require prolonged neonatal intensive care unit (NICU) hospitalizations.

      When the study was begun in 1988, infants with BPD who survived to NICU discharge required
      home oxygen therapy for months to years. In addition, they had a 50-69 percent chance of
      re-hospitalization and an 11-36 percent probability of death in the first year of life.
      Although improvement with age was often seen, pulmonary function abnormalities persisted into
      late childhood or beyond in at least 75 percent. Among other associated morbid sequelae were
      myocardial and pulmonary vascular dysfunction, cor pulmonale, systemic hypertension, growth
      failure, and neurodevelopmental abnormalities. Pathologic studies showed structural pulmonary
      and myocardial abnormalities in the most severely affected infants.

      Of advances in the field of neonatology, one of the most exciting was the experimental use of
      exogenous surfactant. Neonatal clinicians and researchers looked to these preparations for
      specific therapy for hyaline membrane disease and indirect reduction of neonatal mortality
      and chronic pulmonary disease of prematurity. Published clinical studies of exogenous
      surfactant were supportive of the anticipated trends in neonatal mortality and morbidity. Up
      to 1988, however, surfactant therapy was shown to have a more appreciable impact on acute
      respiratory disease and neonatal mortality than on the rate of bronchopulmonary dysplasia.
      Unfortunately, published trials reported that even surfactant-treated premature infants
      developed fatal bronchopulmonary dysplasia.

      DESIGN NARRATIVE:

      The design was that of a retrospective, case-control study. The populations of babies studied
      in the Phenobarbital Study and the Antenatal Risk Factor Study were not identical and
      therefore, were not combined for analysis but allowed hypotheses generated in one sample to
      be tested in the other. In a review of medical records, cases were chosen based on the
      clinical criterion of a requirement for supplemental oxygen for 28 days or more. An
      additional requirement for case status was the presence of classical stages II, III, or IV
      radiographic findings of bronchopulmonary dysplasia/chronic pulmonary disease of prematurity.
      Positive readings by two independent pediatric radiologists were required for case
      assignment. Control infants were those who failed to meet case criteria. Hypothesis testing
      proceeded from univariate to stratified analyses and, finally, to multivariate modeling.
      Candidates for multivariate analysis included: antenatal factors such as maternal age, race,
      marital status, obstetric history and pregnancy history; perinatal factors such as birth
      weight, gestational age, degree of illness; neonatal factors such as respiratory condition,
      body fluids, and miscellaneous laboratory data.

      The study completion date listed in this record was obtained from the "End Date" entered in
      the Protocol Registration and Results System (PRS) record.
    


Study Type

Observational




Condition

Lung Diseases



Publications

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

Recruitment Information




Start Date

December 1988

Completion Date

November 1990


Eligibility Criteria

        No eligibility criteria
      

Gender

Male

Ages

N/A - 100 Years

Accepts Healthy Volunteers

No

Contacts

, , 



Administrative Informations


NCT ID

NCT00005293

Organization ID

2015

Secondary IDs

R01HL040454


Study Sponsor

National Heart, Lung, and Blood Institute (NHLBI)


Study Sponsor

, , 


Verification Date

April 2000