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Birth Asphyxia clinical trials

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NCT ID: NCT05275725 Recruiting - Birth Asphyxia Clinical Trials

Finding Solutions to Thrive After Birth Asphyxia in Africa

SANE-Uganda
Start date: July 1, 2022
Phase: Phase 1
Study type: Interventional

Neonatal encephalopathy (NE) is the third leading cause of under 5-year mortality and contributes substantially to long-term neurological morbidity worldwide. In low-income countries (LICs), families often lack the resources to care for affected children. For those with disabilities, stigma is high, and social and emotional impacts are substantial. Improving our understanding of NE in LICs is crucial if intervention strategies are developed. Providing access to an affordable and easy-to-administer treatment after birth may improve survival, early brain development and later outcome, maximizing developmental potential. The primary objective of this study is to investigate the feasibility, safety and tolerability of administering sildenafil as a neuroprotective/neurorestorative strategy to improve early brain development in a cohort of children with NE in Uganda.

NCT ID: NCT04043299 Recruiting - Birth Asphyxia Clinical Trials

Effect of Intrapartum Oxygen Administration on Fetal and Early Neonatal Outcomes

Intra-O
Start date: March 16, 2020
Phase: Phase 3
Study type: Interventional

Introduction Birth asphyxia is one of leading causes of neonatal mortality in Uganda. It is associated with long term neuro-developmental complications among the babies that survive. Preventive measures for birth asphyxia intrauterine are not clearly understood and thus the need for this study. The aim of the study is to assess the effect of intrapartum oxygen administration on fetal and early neonatal outcomes. Methods A double-blind randomized clinical trial which will be conducted in Gulu regional referral and Kawempe National referral hospitals in Uganda. A total sample size of 1108 women in labour will be enrolled with 554 participants per group. The intervention will include administration of 10 L/min of 100% oxygen for 15 minutes to women in established labor who have signs of fetal distress with fetal heart rate of less than 120 or above 160 beats per minute. The control group will receive medical air (21% oxygen) using the same criteria. Women and babies will be followed up until 7 days after birth to document the outcomes. Statistical analysis to identify difference in outcomes between the control and intervention groups will be performed. Ethical considerations Ethical approval and permission was received from relevant research and ethics committees. Informed consent will be sought from the participants. A data and safety monitoring board will be set up to review periodically the progress of the clinical trial study. Participants will be monitored for adverse events and severe adverse events; reporting will be done according to the research and ethics committee guidelines.

NCT ID: NCT03682042 Recruiting - Clinical trials for Hypoxic-Ischemic Encephalopathy

Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries Developmental Follow Up

CORDMILK-FU
Start date: October 17, 2022
Phase: N/A
Study type: Interventional

An extension of the CORDMILK trial, the CORDMILK follow-up trial will evaluate the neurodevelopmental outcomes at 22-26 months age of term/late preterm infants who were non-vigorous at birth and received umbilical cord milking (UCM) or early cord clamping (ECC).

NCT ID: NCT03657394 Recruiting - Clinical trials for Hypoxic-Ischemic Encephalopathy

Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries

CORDMILK
Start date: October 17, 2022
Phase: N/A
Study type: Interventional

The investigators will conduct a study on non-vigorous infants at birth to determine if umbilical cord milking (UCM) results in lower rate of moderate to severe hypoxic ischemic encephalopathy (HIE) or death than early clamping and for infants who are non-vigorous at birth and need immediate resuscitation.

NCT ID: NCT03577054 Recruiting - Neonatal Death Clinical Trials

Development of a Mobile Application for HBB Prompt Study

HBB-Prompt
Start date: May 14, 2018
Phase: N/A
Study type: Interventional

This study applies an iterative user-centred design approach involving frontline birth attendants to create a mobile application ("HBB Prompt") to improve skills retention after initial newborn stabilization training through the Helping Babies Breathe (HBB) program. HBB Prompt will then be piloted at one site after HBB training and skills retention will be compared with a control site without HBB Prompt after HBB training.