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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03112018
Other study ID # A123218-K/U
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2016
Est. completion date May 31, 2019

Study information

Verified date June 2019
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether a combination of evidence-based strategies can improve intrapartum and newborn care in facilities to reduce mortality among preterm infants. This will be a cluster randomized implementation science study across 23 facilities in Eastern Uganda and Western Kenya. Selected interventions will be supported in facilities to measure impact during the study period. These interventions are: a) data strengthening and data use activities; b) implementation of a modified WHO Safe Childbirth Checklist with an emphasis on preterm labor and preterm babies; c) simulation-based provider training and mentoring on key existing evidence-based practices to improve newborn outcomes; d) support of Quality Improvement (QI) cycles to identify and resolve facility-specific issues and bottlenecks. A two-stage design will be used where all study facilities will receive some aspects of the intervention initially, namely data strengthening and the modified checklist. Subsequently, the remaining interventions (QI cycles and simulation training of providers) will be rolled out to a randomly selected half of the facilities in the first stage. At a second stage, the remaining half of the facilities will receive the remaining interventions.


Description:

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Study Design


Intervention

Behavioral:
data strengthening
Data strengthening: initial training, monthly data collection and feedback on data quality, access to dashboards, periodic Data Quality Assessments
modified Safe childbirth checklist - control
modified Safe Childbirth Checklist (mSCC) implementation: provision of the mSCC to facilities, limited feedback and mentoring on its use
modified Safe childbirth checklist - enhanced
modified Safe Childbirth Checklist (mSCC) implementation: provision of the mSCC to facilities, ongoing intensive feedback and mentoring on its use
PRONTO training
Health provider training (PRONTO): initial 2-days modular training followed by a 6-week mentoring sessions (Kenya) or periodic modular refreshers and supplemental mentoring (Uganda), each over a 9-12 month period
QI cycles
Quality Improvement Cycles (QI): facility teams performing PDSA cycles with mentoring support and twice annual Learning Collaborative sessions, plus opportunities to apply for small amounts of funds to support change efforts

Locations

Country Name City State
Kenya Health facilities in Migori County: Rongo, Kehancha, Uriri, Kegonga, Karungu, Tisinye, Isibania, Macalder, Awendo, Ntimaru, Muhuru, Bugumbe, Nyamaraga, Othoro, St. Joseph, St. Camillus, Migori County Referral Hospital Migori County
Uganda Health facilities in Busoga Region: Bugiri, Buluba, Iganga, Kamuli Government, Kamuli Mission, Jinja Regional Referral Hospital Busoga Region

Sponsors (3)

Lead Sponsor Collaborator
University of California, San Francisco Kenya Medical Research Institute, Makerere University

Countries where clinical trial is conducted

Kenya,  Uganda, 

Outcome

Type Measure Description Time frame Safety issue
Primary all-cause neonatal mortality among preterms/low birth weight newborns To determine the effect of the full package (data strengthening, mSCC, provider training and mentoring using the PRONTO method, QI cycles) on 28-day all-cause mortality rate among low birth weight neonates greater than 1000 grams and less than 2500 grams, and neonates between 2500 and 2999 grams with documented gestational age less than 37 weeks 28-days after facility-based delivery
Secondary Data quality of key indicators in facility-based registers Key indicators include gestational age, facility discharge status, preterm birth incidence through study completion, an average of 18 months
Secondary Pre-hospital discharge mortality among preterm infants and babies born alive between 500 and 999 grams at birth at hospital discharge, an average of 1-7 days
Secondary 28-day mortality among babies born alive between 500 and 999 grams at birth 28-days after facility-based delivery
Secondary Average number of evidence-based practices demonstrated in simulated case videos and live birth observations Uptake and appropriate utilization of evidence-based interventions/ Ministry of Health management guidelines measured in PRONTO simulation videos, observed live births and/or mSCC Baseline and through study completion, an average of 18 months
Secondary Prevalence of preterm birth phenotypes in the study sites as measured by chart review and the mSCC Every year over four years
Secondary Facility readiness to handle delivery and newborn complications as measured by a facility assessment tool Every six months over two years
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