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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/24/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/24/2021.

Impact of the PREEMI Package on Neonatal Mortality

Clinicaltrials.gov identifier NCT03923023

Recruitment Status Completed

First Posted April 22, 2019

Last update posted April 23, 2019

Study Description

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.

  • Condition or Disease:Neonatal Death
    Preterm Birth
    Preterm Labor
  • Intervention/Treatment:
  • Phase: N/A
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 Design
  • Study Type: Observational [Patient Registry]
  • Actual Enrollment: 11195 participants
  • Observational Model: Cohort
  • Time Perspective: Prospective
  • Official Title: Preterm Resources, Education, and Effective Management for Infants
  • Actual Study Start Date: November 2014
  • Actual Primary Completion Date: October 2017
  • Actual Study Completion Date: June 2018
Outcome Measures
  • Primary Outcome Measures: 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 Outcome Measures: 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
Eligibility Criteria
  • Ages Eligible for Study: 10 Years and older (Child, Adult, Older Adult)
  • Sexes Eligible for Study: Female
  • Accepts Healthy Volunteers: Yes
  • Sampling Method: Non-Probability Sample
  • Study Population: Pregnant women who seek antenatal care and delivery services at the selected 3 health facilities.
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

Contacts and Locations
Contacts
Locations

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

Sponsors and Collaborators

University of Alabama at Birmingham

Centre for Infectious Disease Research in Zambia

Investigators

Principal Investigator: Albert Manasyan, MD, MPH University of Alabama at Birmingham

More Information
  • Responsible Party: University of Alabama at Birmingham
  • ClinicalTrials.gov Identifier: NCT03923023 History of Changes
  • Other Study ID Numbers: 14-F0023
  • First Posted: April 22, 2019 Key Record Dates
  • Last Update Posted: April 23, 2019
  • Last Verified: April 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Yes
  • Plan Description: Should there arise interest for the study data to be reviewed and analyzed, a Material Transfer Agreement between Ministry of Health and the implementing partner (CIDRZ) needs to be approved before data is exported from Zambia.
  • Supporting Materials: Study Protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)
  • Time Frame: Dependent on the need and time it'll take to receive a Material Transfer Agreement from Ministry of Health.
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by University of Alabama at Birmingham: Facility delivery
    Neonatal mortality
    Preterm delivery
    Preterm birth
    Perinatal mortality
  • Additional relevant MeSH terms: Premature Birth
    Obstetric Labor, Premature
    Perinatal Death