Risk Factors in Bronchopulmonary Dysplasia (Newborn Lung Project)

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Brief Title

Risk Factors in Bronchopulmonary Dysplasia (Newborn Lung Project)

Official Title

Risk Factors in Bronchopulmonary Dysplasia (Newborn Lung Project)

Brief Summary

      To investigate risk factors in bronchopulmonary dysplasia (BPD) and to elucidate the
      relationship between BPD, acute lung disease severity, respiration-related variables, water
      balance, nutrition, familial predisposition, and environmental, pregnancy, and delivery
      parameters.
    

Detailed Description

      BACKGROUND:

      Despite many improvements in neonatal intensive care during the decade from 1977 to 1987,
      infant respiratory distress syndrome remained a major public health problem. Increasing
      survival among premature infants led to the emergence of BPD as the major chronic respiratory
      disorder of infancy. The vast majority of BPD occurs in very low birth weight infants
      weighing less than 1,500 grams.

      Although the incidence of low birth weight births declined from 1977 to 1987, the rate of
      very low birth weight births remained unchanged. These infants had a relative risk of
      neonatal death almost 200 times greater than full-term infants. Among survivors, eight
      percent had evidence of chronic pulmonary disease at forty weeks of age. The Institute of
      Medicine reported that very low birth weight infants who survived to one year of age were
      hospitalized for an average of 57 days after birth versus 3.5 days for full-term infants. Up
      to forty percent of these infants would be re-hospitalized almost two times for an average of
      16 days versus 8.7 percent of normal birth weight infants for an average of 8 days.

      DESIGN NARRATIVE:

      The study had a nested case-control design. In the first year of the project, the diagnosis
      of BPD was standardized and a scoring system developed for grading the severity of the
      disease. Baseline data were collected on very low birth weight neonates admitted to seven
      participating neonatal intensive care units. Maternal interviews were conducted for neonates
      surviving seven days. The purpose of the interview was to collect information which m;ight be
      related to a predisposition to BPD, respiratory distress syndrome, or prematurity. Specific
      areas addressed included familial diseases in general and respiratory diseases in particular,
      familial patterns of prematurity, pregnancy and birth history, circumstances surrounding
      delivery, environmental exposures, health habits such as smoking, and socioeconomic
      variables. Severity scoring and diagnosis of the infants were based on the hospital log and
      routine x-rays. Final analysis compared infants with BPD to those without BPD, controlling
      for confounders and placing special emphasis on interaction effects. Full-term neonates
      served as controls.

      The study was renewed in 1994 in order to re-contact at age 4-5, an existing cohort of 634
      children with birth weight below 1501 grams. This cohort was unique in being representative
      of all very low birth weight survivors in a geographic area, and in being born during a time
      period of rapid advances in neonatal care (Aug 1, 1988-June 30, 1991). These children were
      enrolled at admission to any of 6 neonatal intensive care units (NlCUs) in Wisconsin and
      Iowa, and had extensive data already collected. The re-contact consisted of a telephone
      interview with parents, including standardized functional assessment. Information on health
      care and major diagnoses was also collected and verified by medical record abstracting.
      Information on socioeconomic and insurance status was obtained. The study responded to a need
      for global assessment of very low birth weight survivors, since most previous studies in the
      United States focused on specific morbidity outcomes. Special features of already existing
      data included scoring of respiratory distress syndrome and bronchopulmonary dysplasia
      severity with new validated severity indices, baseline family health history information and
      perinatal data. The cohort also spanned the time period from before general availability of
      exogenous surfactant to its availability as an investigational new drug (8/1/89) and
      availability for marketing (8/1/90). The study therefore provided an opportunity to
      investigate the long term effectiveness of this new therapy in an unselected NlCU population.
      The data were analyzed to describe the overall status of the cohort, to examine trends in
      outcomes across the time period, to find predictors of outcome among the neonatal and
      socioeconomic indicators and to investigate whether there was variability between centers.

      The study was renewed in 1998 to continue follow-up of the cohort of 403 very low birth
      weight neonatal care survivors, born during August 1988-June1991. The time period of birth
      includes the approval dates for surfactant therapy. Hence, the first children to be treated
      with surfactant in general neonatal intensive care units (NICU) are now entering school age,
      providing an opportunity to evaluate school performance and to assess true chronicity of
      respiratory limitations. A large NICU and follow-up data base on the cohort contains
      extensive baseline assessment of respiratory disease, neonatal treatments and diagnoses, as
      well as functional assessment, health status and health care utilization at ages 4-6. The
      addition of data up to age 10 will confirm or dispute findings that functional outcome may be
      lower among children born after surfactant was released for marketing, and that the
      prevalence of long-term respiratory problems has remained the same. The new outcome data to
      be collected include school performance from school records and parent and teacher
      questionnaires, respiratory function by peak flow meters and respiratory symptoms and
      medications by parent interviews and questionnaires.

      The study was renewed in 2002 to continue research in the evolving risk factors and outcomes
      of bronchopulmonary dysplasia (BPD) and other neonatal conditions of very low birth weight
      (VLBW, < 1500g) infants and children. The renewal will comprehensively document the neonatal
      and early childhood course and outcomes of all VLBW births in Wisconsin occurring during the
      calendar years 2003 and 2004 (800-850 per year), using established methodology with added
      risk factor information to examine currently proposed inflammatory hypotheses of BPD
      etiology. The study will also implement and validate new diagnostic criteria for the severity
      of BPD developed by a recent NIH workshop.
    


Study Type

Observational




Condition

Bronchopulmonary Dysplasia


Study Arms / Comparison Groups

 1988-1991
Description:  

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

2202

Start Date

July 1987

Completion Date

July 2008

Primary Completion Date

July 2008

Eligibility Criteria

        - Birthweight less than 1500 grams
      

Gender

All

Ages

N/A - 100 Years

Accepts Healthy Volunteers

No

Contacts

Mari Palta, , 



Administrative Informations


NCT ID

NCT00005289

Organization ID

1997-152

Secondary IDs

R01HL038149

Responsible Party

Sponsor

Study Sponsor

University of Wisconsin, Madison

Collaborators

 National Heart, Lung, and Blood Institute (NHLBI)

Study Sponsor

Mari Palta, , University of Wisconsin, Madison


Verification Date

July 2019