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Saving Babies Lives

NCT04663620 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24040

Last updated 2026-02-19

No results posted yet for this study

Summary

The central hypothesis of this study is that a neonatal healthcare programme that has a significant impact on neonatal mortality and which spans the healthcare journey from village to referral hospital can be developed and implemented in a low-resource rural setting.

This study is a five-year cluster-randomised trial, covering a rural and isolated province in North-Eastern Cambodia. The intervention of this study is the Saving Babies' Lives programme, which is a comprehensive, contextual and iterative neonatal healthcare package. The Saving Babies' Lives programme comprises a training programme for primary care facilities, and participatory action research with community health workers (known in Cambodia as village health support group volunteers). The control is no intervention; standard government service continues. Qualitative and quantitative data collection supports improvements in the iterative programme, and evaluation of the study, with the intention of creating a scalable blueprint.

Wellcome Trust grant number 220211.

Conditions

  • Perinatal Mortality

Interventions

BEHAVIORAL

Saving Babies Lives Programme

Comprehensive neonatal healthcare package

BEHAVIORAL

No Saving Babies Lives Programme

No comprehensive neonatal healthcare package

Sponsors & Collaborators

  • University of Oxford

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2023-02-28
Completion
2023-02-28

Countries

  • Cambodia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04663620 on ClinicalTrials.gov