Impact of the PREEMI Package on Neonatal Mortality

NCT03923023 | Completed

• 1 other identifier: 14-F0023
• Study Type: observational
• Target: 11,195
• Locations: 1 country
• Sites: 2

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.

Conditions

Preterm Birth; Preterm Labor; Neonatal Death

Keywords

Facility delivery; Neonatal mortality; Preterm delivery; Preterm birth; Perinatal mortality

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  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.

  Baseline to 36 months

Eligibility Criteria

• Age: 10 Years+
• Gender Eligibility Details: Pregnant women who seek antenatal care and delivery services at the selected 3 health facilities.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Centre for Infectious Disease Research in Zambia: collaborator

Study Sites (2)

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

Lusaka, 10101, Zambia

Location

University Teaching Hospital

Lusaka, 10101, Zambia

Location

Related Publications (2)

• 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.

  PMID: 36048848 DERIVED

• 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.

  PMID: 33176718 DERIVED

MeSH Terms

Conditions

Premature Birth; Obstetric Labor, Premature; Perinatal Death

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Albert Manasyan, MD, MPH

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 42 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 15, 2019
• First Posted: April 22, 2019
• Study Start: November 1, 2014
• Primary Completion: October 31, 2017
• Study Completion: June 30, 2018
• Last Updated: May 9, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: The data will be shared with the requesting investigator/entity.
• Access Criteria: For secondary analysis purposes or verification of publication results.

Locations

ZA (2)