Neonatal Outcome by Reason for Delivery
Condition: Preterm Delivery
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      To determine the rate of Composite Neonatal Morbidity for very preterm babies delivered
      secondary to preterm labor (PTL) vs. prelabor rupture of membranes (PROM). Composite neonatal
      morbidity is defined as ≥ 1 of the following: Respiratory Distress Syndrome (RDS) (oxygen
      requirement, clinical diagnosis, and consistent chest radiograph), bronchopulmonary dysplasia
      (BPD) (requirement for oxygen support at 28 days of life), severe intraventricular hemorrhage
      (IVH) (grades III or IV), periventricular leukomalacia (PVL), blood culture-proven sepsis,
      necrotizing enterocolitis (NEC), or perinatal death (stillbirth or death before neonatal
      hospital discharge.
    

Detailed description: 
      This is a prospective, observational study that will use information from the medical records
      of mothers and their newborns. This study seeks to determine the rate of Composite Neonatal
      Morbidity for very preterm babies delivered secondary to preterm labor (PTL) vs. prelabor
      rupture of membranes (PROM). Composite neonatal morbidity is defined as ≥ 1 of the following:
      Respiratory Distress Syndrome (RDS) (oxygen requirement, clinical diagnosis, and consistent
      chest radiograph), bronchopulmonary dysplasia (BPD) (requirement for oxygen support at 28
      days of life), severe intraventricular hemorrhage (IVH) (grades III or IV), periventricular
      leukomalacia (PVL), blood culture-proven sepsis, necrotizing enterocolitis (NEC), or
      perinatal death (stillbirth or death before neonatal hospital discharge.

      Secondary Objectives: 1) Difference in mortality between the PTL and PROM groups, composite
      morbidity differences for other reasons for premature delivery, and individual morbidities
      including IVH, PVL, RDS, sepsis, seizures, BPD and NEC

      Study Population: All babies from singleton pregnancies delivering in each of the involved
      hospitals who deliver at less than 32 weeks of gestation who are stillborn, who die in the
      delivery room and who are cared for in the Neonatal Intensive Care Unit (NICU) will be
      included.

      Planned Sample Size: We plan a two year study and estimate based on historical data for the
      institutions to be included in the study, which should yield approximately 6000 babies less
      than (<) 32w0d gestation. For a 10% difference in composite morbidity (assuming 90% power and
      two-sided alpha=0.05) assuming a rate of 60% at least 661 patients are needed in each of the
      3 groups (PTL, PROM, and other).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All babies from singleton pregnancies delivering in each of the involved hospitals who
        delivered at less than 32 weeks of gestation and who are stillborn, who die in the delivery
        room and who are cared for in the Neonatal Intensive Care Unit (NICU) will be included.
      
Keywords: Preterm delivery; Premature delivery; Premature birth