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Completed

NCT Number: NCT03923023

Impact of the PREEMI Package on Neonatal Mortality

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.

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Key information

Age range

10 year and older

Sex eligibility

Female

Study type

Observational

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 10% relative risk reduction in 28-day neonatal mortality rate in preterm infants

    Time frame: Baseline to 36 months

    Rate of 28-day neonatal mortality at the end of the study compared to that at baseline

Secondary outcomes

  1. 20% relative risk reduction in all-cause 7-day neonatal mortality in preterm infants

    Time frame: Baseline to 36 months

    Rate of 7-day neonatal mortality at the end of the study compared to that at baseline

  2. Factors that contribute to home and facility deliveries within the PREEMI facility catchment areas through the use of pre-determined questionnaire.

    Time frame: Baseline to 36 months

    Number of study participants who delivered at home and at a health facility

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Centre for Infectious Disease Research in Zambia

Registry information

Official study title

Preterm Resources, Education, and Effective Management for Infants

Acronym: PREEMI

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Apr 22, 2019
Registry last updated
May 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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