Prematurity and Respiratory Outcomes Program (PROP)
Condition: Prematurity; Respiratory Disease
MeSH terms: Respiratory Tract Diseases; Respiration Disorders; Premature Birth
Study type: Observational

Summary: 
      In survivors of extreme prematurity to 36 weeks Post Menstrual Age (PMA), specific biologic,
      physiologic and clinical data obtained during the initial hospitalization will predict
      respiratory morbidity as defined by respiratory health care utilization and respiratory
      symptoms, between discharge and 1 year corrected age.

      This protocol describes a collaboratively developed multicenter study of very preterm infants
      from birth through the time of discharge from the Neonatal Intensive Care Unit (NICU) and up
      to 1 year of age, corrected for the degree of prematurity.
    

Detailed description: 
      The primary goal of the PROP studies is to identify biomarkers (biochemical, physiological
      and genetic) and clinical variables that are associated with and thus potentially predictive
      of pulmonary status in preterm infants up to 1 year corrected age. An objective and validated
      measure of pulmonary outcome at 1 year does not currently exist. Some promising measures are
      in development but not yet ready for use in a multi-center large clinical study.

      Moreover, the burden of chronic respiratory illness on the infants and their families is of
      utmost importance. A composite primary outcome of morbidity that is based on serial parental
      reports of respiratory symptoms, medications, hospitalizations and dependence on technology
      during the first year of life has been developed.

      Data collection for the outcome assessment will be based on interviews conducted with the
      infant's main caregiver at 3, 6, 9 and 12 months corrected age. The time frame for data
      collection is based on questions "since last contact." Numerous epidemiological studies of
      asthma have used parental or self report of symptoms, physician-diagnosed asthma and
      allergies, or the use of medications (which may abrogate symptoms) as critical outcomes.

      Survey items selected for the determination of the primary outcome will be focused on the
      following four domains, with any positive response to any element identifying morbidity:

        1. Respiratory medications: inhaled bronchodilators, inhaled steroids, systemic steroids,
           methylxanthines, diuretics, pulmonary vasodilators

        2. Hospitalizations for cardiopulmonary causes: any hospitalization regardless of duration

        3. Symptoms: any wheeze, cough without cold

        4. Home technology dependence: use of home oxygen, ventilator or continuous positive airway
           pressure (CPAP or BiPAP) of any duration since last contact

      The primary outcome will be dichotomous, and defined as "No substantial post-prematurity
      respiratory disease" or "Post-prematurity respiratory disease." To be classified as having
      post-prematurity respiratory disease, infants must have a positive response in at least 1 of
      4 morbidity domains during at least 2 separate parental interviews. Quarterly data collection
      up to 1 year corrected age will allow us to identify phenotypes based on the trajectory of
      post-prematurity respiratory disease and how these different trajectories predict later lung
      function and the diagnosis of asthma, if we continue to follow this cohort of children.

      During hospitalization, all centers will obtain samples of tracheal aspirate, urine and
      saliva (for DNA extraction) from enrolled infants. At 36 weeks PMA, infants will have
      respiratory assessments dependent upon their respiratory status: i) respiratory inductive
      plethysmography (RIP) assesses alterations in tidal breathing resulting from reduced lung
      compliance and airway obstruction, ii) and a room air challenge (RAC).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Infants admitted to the Neonatal Intensive Care Unit who are < 29 weeks gestational age
      
Biospecimen description: 
      Saliva for DNA, Urine and Tracheal Aspirate