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Impact of the PREEMI Package on Neonatal Mortality (PREEMI)

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ClinicalTrials.gov Identifier: NCT03923023
Recruitment Status : Completed
First Posted : April 22, 2019
Last Update Posted : April 23, 2019
Sponsor:
Collaborator:
Centre for Infectious Disease Research in Zambia
Information provided by (Responsible Party):
Albert Manasyan, University of Alabama at Birmingham

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
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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 11195 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 42 Days
Official Title: Preterm Resources, Education, and Effective Management for Infants
Actual Study Start Date : November 1, 2014
Actual Primary Completion Date : October 31, 2017
Actual Study Completion Date : June 30, 2018



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



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant women who seek antenatal care and delivery services at the selected 3 health facilities.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03923023


Locations
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Zambia
Chawama 1st Level Hospital, Chipata 1st Level Hospital, and George Clinic
Lusaka, Zambia, 10101
Sponsors and Collaborators
University of Alabama at Birmingham
Centre for Infectious Disease Research in Zambia
Investigators
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Principal Investigator: Albert Manasyan, MD, MPH University of Alabama at Birmingham
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Albert Manasyan, Assistant Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03923023    
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Albert Manasyan, University of Alabama at Birmingham:
Facility delivery
Neonatal mortality
Preterm delivery
Preterm birth
Perinatal mortality
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Perinatal Death
Obstetric Labor Complications
Pregnancy Complications
Death
Pathologic Processes