Impact of the PREEMI Package on Neonatal Mortality

Completed

• Conditions: Neonatal Death; Preterm Birth; Preterm Labor

• Registration Number: NCT03923023
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-11-01
• Primary Completion: 2017-10-31
• Study Completion: 2018-06-30
• Study First Submitted: 2019-04-15
• Study First Submitted QC: 2019-04-17
• Study First Posted: 2019-04-22
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-03
• Last Update Posted: 2022-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 11195

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

University Teaching Hospital; 🇿🇲 Lusaka, Zambia

Chawama 1st Level Hospital, Chipata 1st Level Hospital, and George Clinic; 🇿🇲 Lusaka, Zambia