Neonatal Outcome by Reason for Delivery

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).

Inclusion Criteria:

- Delivery at participating hospitals at less than 32weeks of gestation based on best
obstetrical dating

- Singleton pregnancy

- Delivery where the baby is:

1. Stillborn OR

2. Born alive and:

- expires before it leaves the delivery room OR

- is cared for in the Neonatal Intensive Care Unit or an Intermediate Care Nursery

Exclusion Criteria:

- Patient less than 18 years of age

- Pregnancies that had previously been multiple gestations but where one or more fetuses
had died after 12weeks of gestation

- Deliveries where the baby is born alive, does not expire in the delivery room but the
baby does not get admitted to the NICU.