Abstract:
Background: Preterm birth (birth before 37 weeks of gestation) and its complications are
the leading contributors to neonatal and under-5 mortality. The majority of neonatal
deaths in Kenya and Uganda occur during the intrapartum and immediate postnatal
period. This paper describes our study protocol for implementing and evaluating a
package of facility-based interventions to improve care during this critical window.
Methods/design: This is a pair-matched, cluster randomized controlled trial across 20
facilities in Eastern Uganda and Western Kenya. The intervention facilities receive four
components: (1) strengthening of routine data collection and data use activities; (2)
implementation of the WHO Safe Childbirth Checklist modified for preterm birth; (3)
PRONTO simulation training and mentoring to strengthen intrapartum and immediate
newborn care; and (4) support of quality improvement teams. The control facilities
receive both data strengthening and introduction of the modified checklist. The primary
outcome for this study is 28-day mortality rate among preterm infants. The denominator
will include all live births and fresh stillbirths weighing greater than 1000 g and less than
2500 g; all live births and fresh stillbirths weighing between 2501 and 3000 g with a
documented gestational age less than 37 weeks.
Discussion: The results of this study will inform interventions to improve personnel and
facility capacity to respond to preterm labor and delivery, as well as care for the preterm
infant.