Preterm BirthPREEMINCT03923023
Impact of the PREEMI Package on Neonatal Mortality
An observational study of Preterm Birth and Preterm Labor, run by University of Alabama at Birmingham at 2 sites in Zambia.
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. Read more about this study
- Who is it for?
- Ages 10 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth, Preterm Labor, Neonatal Death
- How many people
- 11,195 participants
- Where
- 2 sitesZambia
- Study dates
- 1 Nov 2014to 30 Jun 2018
- How long will I take part?
- 42 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Pregnant women who seek antenatal care and delivery services at the selected 3 health facilities.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Zambia2 sites
Chawama 1st Level Hospital, Chipata 1st Level Hospital, and George Clinic
Lusaka, 10101
University Teaching Hospital
Lusaka, 10101
About this study
Official title: Preterm Resources, Education, and Effective Management for Infants
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.
Read the 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.
- Conditions
- Preterm Birth, Preterm Labor, Neonatal Death
- Keywords
- Facility delivery, Neonatal mortality, Preterm delivery, Preterm birth, Perinatal mortality
- Medical subject headings
- Premature Birth, Obstetric Labor, Premature, Perinatal Death
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to 36 months
Secondary outcomes (2)
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
Measured: 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.
Number of study participants who delivered at home and at a health facility
Measured: Baseline to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2019
- Study start1 Nov 2014
- Primary completion31 Oct 2017
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11,195 participants (actual)
- Target duration
- 42 Days
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Centre for Infectious Disease Research in Zambia
- Responsible party
- Principal investigator, Albert Manasyan, University of Alabama at Birmingham
- Investigators
- Albert Manasyan, MD, MPH, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03923023
- Sponsor's protocol ID
- 14-F0023
- Acronym
- PREEMI
- Status last verified
- May 2022
- First submitted
- 15 Apr 2019
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study data will be shared upon a reasonable request to the study PI.
Publications
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.
PubMed 36048848Tembo 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.
PubMed 33176718
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preterm Resources, Education, and Effective Management for Infants
- ClinicalTrials.gov ID
- NCT03923023
- Acronym / sponsor ID
- PREEMI / 14-F0023
- Conditions
- Preterm Birth, Preterm Labor, Neonatal Death
- Keywords
- Facility delivery, Neonatal mortality, Preterm delivery, Preterm birth, Perinatal mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11,195 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Centre for Infectious Disease Research in Zambia
- Study start
- 1 Nov 2014 (actual)
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 22 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 42 Days
Who may qualify
- Ages
- 10 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant women who seek antenatal care and delivery services at the selected 3 health facilities.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
20% relative risk reduction in all-cause 7-day neonatal mortality in preterm infants
Time frame: 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.
Time frame: Baseline to 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
- Derived from this study: PubMed 36048848Muttau 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.
- Derived from this study: PubMed 33176718Tembo 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.
- Individual participant dataSharing planned: Yes. The study data will be shared upon a reasonable request to the study PI.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Albert Manasyan, MD, MPH principal investigator
University of Alabama at Birmingham
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Birth and Preterm Labor, run by University of Alabama at Birmingham at 2 sites in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
10% relative risk reduction in 28-day neonatal mortality rate in preterm infants (time frame: Baseline to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03923023, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2022.