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Infant Mortality clinical trials

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NCT ID: NCT04658680 Recruiting - Infant Mortality Clinical Trials

Can BCG Vaccination at First Health-facility Contact Reduce Early Infant Mortality?

CS-BCG
Start date: February 25, 2021
Phase: Phase 4
Study type: Interventional

Bacillus Calmette-Guérin (BCG) vaccination is recommended at birth to protect against tuberculosis (TB) in countries with high TB burden. BCG is supplied in multidose vials with limited durability after reconstitution. In Guinea-Bissau, this has led to a practice of only opening a BCG vial at specific days, and only if sufficient children are present. Therefore, BCG vaccination is frequently delayed. Accumulating evidence indicates that BCG has beneficial effects on survival beyond the specific protection against tuberculosis, so called non-specific effects (NSEs). The hypothesis of this study is that increasing the availability of BCG and vaccinating children at the first health-facility contact can reduce early infant non-accidental mortality by 25%. In a cluster-randomised crossover trial, 23 health facilities (HFs) in three rural regions in Guinea-Bissau will be randomised to either continue with current practice (typically BCG vaccination once a week if a sufficient number of children are present for vaccination); or to offer additional BCG vaccines to make BCG available every day and open a vial of BCG if there is just one eligible child present. All children born in the three regions and registered during the study period, will be eligible for inclusion into the trial 1 day after birth. If consent is given by the mother, the child will be followed until day 42 after birth, when other vaccines are scheduled to be given. The primary outcome will be non-accidental mortality, secondary outcomes are non-accidental hospital admissions, non-accidental neonatal mortality and cost-effectiveness of making BCG available at the first health-facility contact.

NCT ID: NCT04100577 Completed - Mental Health Clinical Trials

Today Not Tomorrow Pregnancy and Infant Support Program (TNT- PISP)

Start date: October 3, 2019
Phase: N/A
Study type: Interventional

This pilot project aims to implement and investigate the feasibility and acceptability of a unique community based prenatal care and support model for African American women and infants in Dane County. The model, the "Today Not Tomorrow Pregnancy and Infant Support Program (TNT-PISP)" builds on emerging evidence about how to effectively implement and sustain prenatal care in black communities. It combines three approaches-community-based doula programs; group-based models of prenatal care, such as Centering Pregnancy; and community-based pregnancy support groups-into once monthly group sessions held during the prenatal and immediate postpartum period. The project is based at the Today Not Tomorrow Family Resource Center in Madison's East Side Community Center, and carried out in close collaboration with Project Babies, Harambee Village Doulas, and the African American Breastfeeding Alliance of Dane County, Inc.

NCT ID: NCT03400878 Completed - Vaccine Reaction Clinical Trials

Comparing Morbidity and Mortality Effects of Two Different Strains of BCG

Start date: October 14, 2017
Phase: Phase 4
Study type: Interventional

Background: Investigators at Bandim Health Project (BHP, www.bandim.org) in Guinea-Bissau have shown in several randomized trials that the Bacille-Calmette-Guérin (BCG) vaccine against tuberculosis (TB) is associated with reduced mortality in the first months of life. BCG is a live attenuated vaccine, which means that it consists of active tuberculosis bacteria that are not capable of infecting a human with TB. BCG has been grown and maintained at many different laboratories all over the world using slightly different laboratory techniques. Due to the accumulation of genetic mutations in the different BCG strains, many variants of the vaccine exists today. These have different properties when it comes to immune response, side effects, protection against TB and scar formation. The BCG scar status after vaccination is a good marker for the non-specific effects of the vaccine; among BCG-vaccinated infants, those with a BCG scar have improved survival. The investigators hypothesize that the different types of BCG vary in terms of the strength of the non-specific effects and thus the impact on overall morbidity and mortality. In the trial, the investigators will compare the two most widely used BCG strains in the world, BCG-Russia and BCG-Japan, with respect to their non-specific effects on morbidity and mortality. As an addition, the investigators will study the effect of maternal BCG vaccination on the subsequent effect of BCG-vaccination in the offspring, since there are indications that the maternal BCG scar status primes for a stronger non-specific response in the offspring.

NCT ID: NCT02504203 Terminated - Infant Mortality Clinical Trials

Can Earlier BCG Vaccination Reduce Early Infant Mortality? A Randomised Trial

BCGR
Start date: November 2015
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether BCG vaccination shortly after birth can reduce early infant mortality in a rural and an urban setting.

NCT ID: NCT02331082 Recruiting - Infant Mortality Clinical Trials

Integrating Pediatric Care Delivery in Rural Healthcare Systems

Start date: November 1, 2014
Phase: N/A
Study type: Interventional

Globally, over seven million children under the age of five die each year, although a suite of interventions—safe delivery care, neonatal care and resuscitation, and management of childhood diarrhea, malnutrition, and pneumonia—can prevent many of these deaths when implemented within functioning health systems. This study will include a quasi experimental, stepped wedge, cluster-controlled trial of a mobile health care coordination and quality improvement intervention designed to facilitate comprehensive health systems strengthening. It will do this through training and equipping community-level health care clinics to manage chronic diseases through use of the Chronic Care Model, structured quality improvement sessions to promote clinical mentorship, and use of an integrated electronic medical record to provide real-time data for disease surveillance. The investigators hypothesize that improving upon the health system in these ways will lead to a 25% reduction in under-two mortality through improved services for the citizens of Achham, Nepal.

NCT ID: NCT02189265 Completed - Premature Birth Clinical Trials

Assessing the Impact of Smoke-free Legislation on Perinatal Health in the Netherlands

Start date: January 2000
Phase: N/A
Study type: Observational

The purpose of this study is to investigate whether there has been a change in perinatal outcomes following the phased smoking ban introduction (January 2004 for workplaces; July 2008 for bars and restaurants) workplaces in the Netherlands.

NCT ID: NCT02185625 Completed - Clinical trials for Postpartum Hemorrhage

Reduction of Adverse Pregnancy Outcomes With a Smartphone Application in Ghana

Start date: July 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether use of the Safe Delivery smartphone application by midwives can reduce excess blood loss from bleeding, and infant death during childbirth in Ghanaian women. Moreover, it will be investigated whether the Safe Delivery application can increase midwives' knowledge and skills in managing childbirth. Fifteen hospitals in Greater Accra, Ghana, will be cluster randomized to either use the Safe Delivery application (intervention), or to no intervention (control). In the intervention hospitals, midwives will be educated in the use of Safe Delivery. Pregnant women will be enrolled at delivery and followed until 7 days postpartum. Data collection will begin July 2014 and is expected to be finished by October 2014.

NCT ID: NCT02039583 Completed - Stillbirth Clinical Trials

Impact of Smoke-free Legislation on Early-life Mortality and Low Birth Weight in England

Start date: January 1995
Phase: N/A
Study type: Observational

The purpose of this study is to investigate whether there has been a change in low birth weight and perinatal and infant mortality following the July 2007 introduction of a ban on smoking in public places and workplaces in England.

NCT ID: NCT00860470 Completed - Preterm Birth Clinical Trials

Antenatal Micronutrient Supplementation and Infant Survival

JiVitA-3
Start date: January 2008
Phase: Phase 3
Study type: Interventional

The purpose of this community-based randomized trial is to examine whether a daily antenatal and postnatal multiple micronutrient supplement given to women will enhance newborn and infant survival and health and other birth outcomes in a rural setting in northwestern Bangladesh.

NCT ID: NCT00198822 Completed - Clinical trials for Vitamin A Deficiency

Impact of Maternal Vitamin A or Beta-Carotene Supplementation on Maternal and Infant Mortality in Bangladesh

Start date: August 2001
Phase: Phase 3
Study type: Interventional

The purpose of this trial is to determine whether providing women with a weekly oral supplement of vitamin A, either preformed or as beta-carotene, at a dosage equivalent to a recommended intake from early pregnancy through three months postpartum, can reduce the risk of maternal mortality, fetal loss, or infant mortality.