Impact of the PREEMI Package on Neonatal Mortality (PREEMI)

Preterm Resources, Education, and Effective Management for Infants

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.

Study Overview

• Status: Completed
• Conditions: Preterm Birth; Preterm Labor; Neonatal Death

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 Type: Observational
• Enrollment (Actual): 11195

Contacts and Locations

Study Locations

• Zambia
  • Lusaka, Zambia, 10101
    • Chawama 1st Level Hospital, Chipata 1st Level Hospital, and George Clinic
  • Lusaka, Zambia, 10101
    • University Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women who seek antenatal care and delivery services at the selected 3 health facilities.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: Centre for Infectious Disease Research in Zambia

Publications and helpful links

General Publications

• Muttau N, Mwendafilumba M, Lewis B, Kasprzyk K, Travers C, Menon JA, Mutesu-Kapembwa K, Mangangu A, Kapesa H, Manasyan A. Strengthening Kangaroo Mother Care at a tertiary level hospital in Zambia: A prospective descriptive study. PLoS One. 2022 Sep 1;17(9):e0272444. doi: 10.1371/journal.pone.0272444. eCollection 2022.
• Tembo T, Koyuncu A, Zhuo H, Mwendafilumba M, Manasyan A. The association of maternal age with adverse neonatal outcomes in Lusaka, Zambia: a prospective cohort study. BMC Pregnancy Childbirth. 2020 Nov 11;20(1):684. doi: 10.1186/s12884-020-03361-5.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2014
• Primary Completion (ACTUAL): October 31, 2017
• Study Completion (ACTUAL): June 30, 2018

Study Registration Dates

• First Submitted: April 15, 2019
• First Submitted That Met QC Criteria: April 17, 2019
• First Posted (ACTUAL): April 22, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 9, 2022
• Last Update Submitted That Met QC Criteria: May 3, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Perinatal mortality; Preterm birth; Neonatal mortality; Preterm delivery; Facility delivery
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Death; Premature Birth; Obstetric Labor, Premature; Perinatal Death
• Other Study ID Numbers: 14-F0023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study data will be shared upon a reasonable request to the study PI.
• IPD Sharing Time Frame: The data will be shared with the requesting investigator/entity.
• IPD Sharing Access Criteria: For secondary analysis purposes or verification of publication results.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No