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Table 2 Select secondary outcomes

From: 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

Secondary outcome

How variable will be measured

Time frame

Data quality of key indicators in facility-based registers (includes GA, facility discharge status, preterm birth incidence)

GA-birthweight concurrence, DQAs and mSCC data review or QI indicators

Baseline through study completion, an average of 18 months; at least quarterly

Pre-discharge mortality among all infants > 1000 g

Clinical record review at facility

Baseline and through study completion, an average of 18 months

Facility-based maternal mortality

Clinical record review at facility

Baseline and through study completion, an average of 18 months

Perinatal mortality (fresh stillbirths and deaths within 7 days) among eligible preterm infants (includes pre-discharge mortality)

Parental report at 28 days and clinical record review at facility

Baseline and through study completion, an average of 18 months

Mortality among preterm infants and those born alive between 500 g and 999 g at birth (include pre-discharge mortality and 28-day mortality)

Parental report at 28 days and clinical record review at facility at time of first contact

Baseline and through study completion, an average of 18 months

Average number of EBPs or Ministry of Health management guidelines demonstrated in simulated case videos and live birth observations

Measured in PRONTO simulation videos, observed live births and/or mSCC. To be complemented by pre-post knowledge tests and facility assessments

Baseline and through study completion, an average of 18 months. PRONTO administered at pre-determined time points

Knowledge improvement of EBPs

PRONTO pre-post knowledge test scores

PRONTO administered at pre-determined time points

Proportion of eligible cases receiving EBPs reported by QI teams (QI indicators include Kangaroo Care, antenatal corticosteroid provision, and breastfeeding)

QI indicators reported at learning sessions

Baseline and through study completion, an average of 18 months; QI learning sessions held every 3–6 months

Facility readiness to handle delivery and newborn complications

Measured by a facility assessment tool

Bi-annually over the study period

Understanding of contextual factors influence implementation of strengthening maternal and newborn care interventions

Process evaluation that incorporates document review, surveys and qualitative interviews and focus groups

To be conducted mid-study

Prevalence of preterm birth phenotypes in the study sites

Retrospective and/or prospective chart review

Baseline and through study completion; at least annually in select sites

  1. GA gestational age, DQA data quality assessment, EBP evidence-based practice, mSCC Modified Safe Childbirth Checklist, QI quality improvement