Clinical trial NCT03923023: Impact of the PREEMI Package on Neonatal Mortality
Official title: Preterm Resources, Education, and Effective Management for Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm Birth
Preterm Labor
Neonatal Death
Keywords: Facility delivery
Neonatal mortality
Preterm delivery
Preterm birth
Perinatal mortality
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Centre for Infectious Disease Research in Zambia
First posted: 2019-04-22
Enrollment: 11195
Sex: FEMALE
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women who seek antenatal care and delivery services at the selected 3 health facilities.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 10% relative risk reduction in 28-day neonatal mortality rate in preterm infants
timeFrame: Baseline to 36 months
Secondary outcomes:
measure: 20% relative risk reduction in all-cause 7-day neonatal mortality in preterm infants
timeFrame: Baseline to 36 months
measure: Factors that contribute to home and facility deliveries within the PREEMI facility catchment areas through the use of pre-determined questionnaire.
timeFrame: Baseline to 36 months
Other outcomes:
Locations:
city: Lusaka
country: Zambia
facility: Chawama 1st Level Hospital, Chipata 1st Level Hospital, and George Clinic
city: Lusaka
country: Zambia
facility: University Teaching Hospital
Study officials:
affiliation: University of Alabama at Birmingham
name: Albert Manasyan, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.