Impact of the PREEMI Package on Neonatal Mortality

Study Overview
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Brief Summary
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The purpose of this Quality Improvement initiative is to reduce severe morbidity and mortality among premature infants through proven and cost-effective clinical management during the antenatal, intrapartum, and postpartum periods. In order to reduce neonatal mortality and morbidity due to preterm birth complications, health facilities must be able to identify and manage women in preterm labor, accurately administer medications, and provide high-quality postnatal care.

Detailed Description
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The purpose of this Quality Improvement initiative is to reduce severe morbidity and mortality among premature infants through proven and cost-effective clinical management during the antenatal, intrapartum, and postpartum periods. In order to reduce neonatal mortality and morbidity due to preterm birth complications, health facilities must be able to identify and manage women in preterm labor, accurately administer medications, and provide high-quality postnatal care. The study will provide evidence of implementing a package of clinical interventions coupled with quality improvement and monitoring strategy aimed at reducing neonatal mortality in 3 resource-limited health facilities, leveraging on an existing strengthened birth registry to provide neonatal outcomes up to 28 days after delivery. Additionally, using a multifaceted approach through an interdisciplinary team, the investigators will identify the social and cultural barriers that contribute to home-based deliveries. These findings will be helpful to the Ministry of Health in shaping future policies regarding the scale-up of newborn care clinical protocols as part of Government's efforts to reducing neonatal mortality in Zambia.

Official Title
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Preterm Resources, Education, and Effective Management for Infants

Conditions
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Preterm Birth, Preterm Labor, Neonatal Death

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women who seek Antenatal care services and plan to deliver in the selected health facilities Women who reside within the larger catchment area of the selected 3 health facilities Exclusion Criteria: Women who reside outside the larger catchment area of the health facilities Women who have not sought antenatal care services in the 3 health facilities and have come to only deliver there

Ages Eligible for Study
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Minimum Age: 10 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 10% relative risk reduction in 28-day neonatal mortality rate in preterm infants | Rate of 28-day neonatal mortality at the end of the study compared to that at baseline | Baseline to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 20% relative risk reduction in all-cause 7-day neonatal mortality in preterm infants | Rate of 7-day neonatal mortality at the end of the study compared to that at baseline | Baseline to 36 months | 
| Factors that contribute to home and facility deliveries within the PREEMI facility catchment areas through the use of pre-determined questionnaire. | Number of study participants who delivered at home and at a health facility | Baseline to 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Facility delivery, Neonatal mortality, Preterm delivery, Preterm birth, Perinatal mortality