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Infant Morbidity clinical trials

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NCT ID: NCT04372667 Completed - HIV/AIDS Clinical Trials

Adaptation and Evaluation of the PMTCT CSC in Dedza and Ntcheu Districts, Malawi

Start date: June 7, 2017
Phase: N/A
Study type: Interventional

This CDC-funded study sought to evaluate the effect of an adapted Community Score Card Approach on maternal retention in ART, maternal retention across the PMTCT service cascade, and the uptake of early infant diagnosis services in Malawi. The study also estimated the cost of the implementation of the Community Score Card Approach.

NCT ID: NCT04206878 Completed - HIV Infections Clinical Trials

Evaluating the Feasibility of Point of Care Birth Testing in Eswatini

Start date: June 1, 2017
Phase:
Study type: Observational

This study aims to assess the feasibility and utility of birth testing using point-of-care (POC) testing in maternity settings in Eswatini.

NCT ID: NCT04206241 Completed - HIV Infections Clinical Trials

Assessing the Feasibility, Acceptability and Effects Of HIV Birth Testing In Maternity Settings In Zimbabwe

Start date: January 1, 2018
Phase:
Study type: Observational

This study aims to assess the feasibility and, acceptability and effects of implementing HIV testing at birth testing using point-of-care (POC) HIV nucleic acid testing (NAT) in maternity settings.

NCT ID: NCT04049526 Completed - Infant Behavior Clinical Trials

The Effects of Different Music Genres on Heart Rate Variability in Extremely and Very Low Birth Weight Newborns

Start date: February 1, 2019
Phase:
Study type: Observational

AIM: to investigate the influence of different music genres on Heart Rate Variability (HRV) of preterm infants. Neonates undergo a daily randomized music listening program. An electrocardiogram is performed to evaluate HRV parameters in each neonate with and without music exposure.

NCT ID: NCT03824067 Completed - HIV/AIDS Clinical Trials

Impact of Point-of-Care EID for HIV-Exposed Infants

POC-EID
Start date: August 1, 2017
Phase: N/A
Study type: Interventional

This mixed methods study will utilize a randomized step-wedge design to assess the impact of point-of-care (POC) versus conventional early infant diagnosis (EID) on key outcomes including timely return of results to caregivers and time to initiation on treatment for HIV-infected infants. Data will be collected through longitudinal clinical follow-up and medical chart extraction of routine records and lab forms. Feasibility and acceptability data will be collected through interviews with mothers/caregivers of HIV-exposed infants, and community focus groups.

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: NCT02716935 Completed - Growth Retardation Clinical Trials

Prebiotics and Microbiota Composition and Functionality in Rural Burkinabe Infants

Start date: March 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the effect of a mixture of prebiotics included in a food supplement on microbiota diversity and functionality, and to explore its subsequent effects on linear growth velocity and morbidity.

NCT ID: NCT02484495 Completed - Infant Morbidity Clinical Trials

Extended Pilot Project Community Based Production of Complementary Food in Ethiopia

Start date: March 2015
Phase: N/A
Study type: Interventional

The purpose of the study is to evaluate the impact of a package of interventions including production and distribution of locally produced complementary foods (via so-called "Grain-banks") and Micronutrient Powders (MNPs) supplementation, and optimized food based Complementary Feeding Recommendation, on growth and micronutrient status of infants and young children. The impact of the intervention package will be evaluated in a quasi-experimental matched-control cluster design in infants and young children between 6 - 29 months of age. The impact, outcome, and output indicators of infants/children will be assessed in cross-sectional samples at baseline, after 9 and 18 months. A total of60 pair clusters are selected in which 15 households per cluster will be identified from the eligible population. A total of 1800 children from intervention and match-controlled clusters, will be sampled in the target age groups. Qualitative and quantitative data will be collected to gather information on Knowledge, Attitude and Practice (KAP), Infant and Young Child Feeding practices, anthropometry and anemia, following the impact pathway developed for the study. Research questions to be answered in this program evaluation are: 1. What impact does the extended pilot (implementation of local complementary food production and MNP) have on: 1. Growth in children 17-29 months of age 2. Infant and Young Child Feeding practices in children (6-23m), and 3. Anemia status in children 11-23 m? 2. What are determining factors for the impact/no impact related to: 1. Immediate outcomes: skills and capacity; knowledge, attitude and practices; and improved access 2. Intermediate outcomes: utilization; provision, and ensuring enabling environment 3. Program performance as measured by program monitoring data on output and activities?

NCT ID: NCT02479815 Completed - Infant Morbidity Clinical Trials

Impact of Low Dose Iron-containing Micronutrient Powders on Iron Status and Morbidity of Young Children in Ethiopia

Start date: March 2015
Phase: N/A
Study type: Interventional

The purpose of the study is to assess the safety of iron supplementation in MNPs. A quasi-experimental matched-control cluster design will be used in, purposely selected, 18 intervention and 18 matched-control clusters of Oromia and South Nations Nationalities and People (SNNP) regions of Ethiopia. A total of 2340 infants 6-11 months of age, from intervention and non-intervention clusters will be enrolled and followed longitudinally for 12 months. Morbidity data using standardized questionnaire, will be collected at baseline, and every two weeks for a period of 12 months Research questions to be answered in this study are: 1. Is the provision of low dose iron-containing Micronutrient Powders (MNPs) to young children with or without iron deficiency safe, as assessed by their morbidity from infectious diseases? 2. What is the impact of the provision of low dose iron-containing Micronutrient Powders (MNPs) to young children on (body) iron status? Morbidity data will be collected at baseline, and every two weeks in the same cohort of children. Body iron status will be assessed at baseline and endline as measured by serum ferritin, serum transferrin receptor, hemoglobin concentration, CRP and AGP. In addition data on the following outcomes will be collected in these children: 1. Anthropometry (weight, height, MUAC) every 4 months 2. Breastfeeding status and consumption of processed complementary food portions in the previous week -every 4 months 3. Compliance to study intervention.

NCT ID: NCT01839812 Completed - Infant Morbidity Clinical Trials

Adrenal Responsiveness During the Perioperative Period in Children Undergoing Congenital Cardiac Surgery

Start date: March 2009
Phase: Phase 1
Study type: Interventional

Our objective was to determine whether a standard 1mg/kg intraoperative dose of dexamethasone results in similar drug levels for all patients and to characterize the relationship between these drug levels and the innate stress response following infant Cardiopulmonary Bypass (CPB). The investigators hypothesized that postoperative dexamethasone levels are highly variable, and that the infant stress response is inversely related to the amount of dexamethasone measured in the blood. To test this theory the investigators simultaneously measured blood levels of dexamethasone and cortisol at critical time points during the perioperative period for infants undergoing CPB for CHD surgery.