Birth Asphyxia Clinical Trial
Official title:
Treatment of Neonatal Encephalopathy With Oral Sildenafil Suspension to Repair Brain Injury Secondary to Birth Asphyxia: An Open-label Dose-finding Clinical Trial (Phase Ib Study)
The investigators will determine the maximum tolerable dose of sildenafil and establish the pharmacokinetic and pharmacodynamic profile of sildenafil in human asphyxiated neonates treated with hypothermia. They will use a 3+3 design to escalate the sildenafil dose up to 6 mg/kg/day (3mg/kg/dose q12h) in asphyxiated neonates demonstrating brain injury despite hypothermia treatment and assess whether we observe any beneficial effects of sildenafil on their brain and cardiopulmonary hemodynamics, without causing serious adverse events
n/a
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01913340 -
Neonatal Erythropoietin And Therapeutic Hypothermia Outcomes in Newborn Brain Injury (NEATO)
|
Phase 1/Phase 2 | |
Completed |
NCT02858583 -
SI + CC Versus 3:1 C:V Ratio During Neonatal CPR
|
N/A | |
Recruiting |
NCT03657394 -
Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries
|
N/A | |
Recruiting |
NCT03682042 -
Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries Developmental Follow Up
|
N/A | |
Withdrawn |
NCT03681314 -
Umbilical Cord Milking in Neonates Who Are Depressed at Birth-Developmental Follow Up (MIDAB-FU)
|
N/A | |
Completed |
NCT02862925 -
Introducing Fetal Scalp Stimulation as an Adjunct to Intermittent Auscultation in Low-Resource Settings.
|
N/A | |
Completed |
NCT01751945 -
Improved Accessibility of EmONC Services for Maternal and Newborn Health: a Community Based Project
|
N/A | |
Terminated |
NCT03885492 -
The Baby-Saver Kit: Clinical Testing of a Device for Neonatal Resuscitation With Intact Cord in Uganda
|
||
Completed |
NCT01743742 -
First-day High Dose Vitamin C, E in Severe Birth Asphyxia
|
Phase 4 | |
Completed |
NCT05946681 -
Sildenafil Citrate to Improve Maternal and Neonatal Outcomes in Low-resource Settings
|
||
Recruiting |
NCT03577054 -
Development of a Mobile Application for HBB Prompt Study
|
N/A | |
Active, not recruiting |
NCT05854745 -
Comparison of Virtual Training to In-Person Training of Helping Babies Breathe in Ethiopia
|
N/A | |
Not yet recruiting |
NCT05707962 -
Neuroprotective Efficacy of Postnatal Magnesium Sulphate in Term Infants With Birth Asphyxia
|
N/A | |
Completed |
NCT01869582 -
Safer Births - Reducing Perinatal Mortality
|
N/A | |
Completed |
NCT01350765 -
Naushero Feroze Neonatal Survival Project
|
N/A | |
Recruiting |
NCT04043299 -
Effect of Intrapartum Oxygen Administration on Fetal and Early Neonatal Outcomes
|
Phase 3 | |
Completed |
NCT01865656 -
A Skills and Drills Intervention for Emergency Obstetrics and Neonatal Care at First Referral Units of North Karnataka
|
N/A | |
Active, not recruiting |
NCT04714502 -
Asphyxia Associated Metabolite Biomarker Investigation 2
|
||
Recruiting |
NCT05275725 -
Finding Solutions to Thrive After Birth Asphyxia in Africa
|
Phase 1 | |
Completed |
NCT04820504 -
Augmented Infant Resuscitator to Enhance Newborn Ventilation
|
N/A |