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. 2018 Jun 5;19(1):313.
doi: 10.1186/s13063-018-2696-2.

Strengthening intrapartum and immediate newborn care to reduce morbidity and mortality of preterm infants born in health facilities in Migori County, Kenya and Busoga Region, Uganda: a study protocol for a randomized controlled trial

Phelgona Otieno  1 , Peter Waiswa  2   3 , Elizabeth Butrick  4 , Gertrude Namazzi  2 , Kevin Achola  1 , Nicole Santos  4 , Ryan Keating  4 , Felicia Lester  4   5 , Dilys Walker  6   7
Affiliations

Strengthening intrapartum and immediate newborn care to reduce morbidity and mortality of preterm infants born in health facilities in Migori County, Kenya and Busoga Region, Uganda: a study protocol for a randomized controlled trial

Phelgona Otieno et al. Trials. .

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.

Trial registration: ClinicalTrials.gov, ID: NCT03112018 . Registered on 13 April 2017.

Keywords: Kenya; Neonatal mortality; Preterm birth; Quality improvement; Simulation training; Uganda.

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Conflict of interest statement

Ethics approval and consent to participate

The study protocol (version 1.0) has been approved by the University of California, San Francisco Institutional Review Board (Study no: 16–19,162), Kenyan Medical Institute Scientific and Ethics Review Unit (SERU protocol no: KEMRI/SERU/CCR/0034/3251), and the Makerere University Higher Degrees, Research, and Ethics Committee (Protocol ID: IRB00011353). The protocol will be reviewed and reapproved on an annual basis and if protocol amendments are needed. Additional file 1 describes the SPIRIT recommended items to address in a clinical trial protocol. The trial is registered at ClinicalTrials.gov, ID: NCT03112018. Consent procedures are described above in “Ethical considerations”; for 28-day follow-up among eligible newborns, mothers will be asked to provide written consent prior to discharge.

Competing interests

PO and PW have no financial or non-financial competing interests to declare. DW is co-founder of PRONTO International.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Schematic of the study design
Fig. 2
Fig. 2
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Figure
Fig. 3
Fig. 3
Logic model for study interventions
See this image and copyright information in PMC

References

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