Impact of the PREEMI Package on Neonatal Mortality

Preterm Birth Clinical Trial

— PREEMI  

Official title:

Preterm Resources, Education, and Effective Management for Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03923023
• Other study ID #: 14-F0023
• Status: Completed
• Start date: November 1, 2014
• Est. completion date: June 30, 2018

Study information

• Verified date: May 2022
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11195
• Est. completion date: June 30, 2018
• Est. primary completion date: October 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 10 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neonatal Death
• Obstetric Labor, Premature
• Perinatal Death
• Premature Birth
• Preterm Birth
• Preterm Labor

Locations

Country	Name	City	State
Zambia	Chawama 1st Level Hospital, Chipata 1st Level Hospital, and George Clinic	Lusaka
Zambia	University Teaching Hospital	Lusaka

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Centre for Infectious Disease Research in Zambia

Country where clinical trial is conducted

Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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