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Impact of the PREEMI Package on Neonatal Mortality

Preterm Resources, Education, and Effective Management for Infants

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03923023
Acronym
PREEMI
Enrollment
11195
Registered
2019-04-22
Start date
2014-11-01
Completion date
2018-06-30
Last updated
2022-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Death, Preterm Birth, Preterm Labor

Keywords

Facility delivery, Neonatal mortality, Preterm delivery, Preterm birth, Perinatal mortality

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.

Interventions

None listed

Sponsors

Centre for Infectious Disease Research in Zambia
CollaboratorOTHER
University of Alabama at Birmingham
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
10 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
10% relative risk reduction in 28-day neonatal mortality rate in preterm infantsBaseline to 36 monthsRate of 28-day neonatal mortality at the end of the study compared to that at baseline

Secondary

MeasureTime frameDescription
20% relative risk reduction in all-cause 7-day neonatal mortality in preterm infantsBaseline to 36 monthsRate 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 monthsNumber of study participants who delivered at home and at a health facility

Countries

Zambia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026