Clinical trials: Neonatal Asphyxia
Hypoxic-Ischemic Encephalopathy
Systemic Hypothermia Improves Outcome of Hypoxic-Ischemic Encephalopathy
Perinatal asphyxia-induced brain injury is one of the most common causes of morbidity and mortality in term and preterm neonates.
- Trial name
- NCT00817401
- Testing
- hypothermia
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Zhengzhou University
Neonatal Oxygen Desaturation, Premature
Non-Invasive Neurally Adjusted Ventilatory Assist (NAVA) Prone vs Supine in Premature Infants
This research study is being done to investigate the effect of changing an infant's body position on how hard the baby works to breathe, the baby's oxygen level, the baby's carbon dioxide level, the baby's lung volume, the baby's…
- Conditions
- Neonatal Oxygen Desaturation, Premature, Ventilator Lung; Newborn, Apnea of Prematurity
- Trial name
- NCT05968586
- Testing
- Body positioning
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Milton S. Hershey Medical Center
Heart Arrest, Birth Asphyxia
SI + CC Versus 3:1 C:V Ratio During Neonatal CPR
Research question In newborn infants requiring CPR, does CC superimposed by sustained inflation compared to 3:1 compression to ventilation ratio improves return of spontaneous circulation? Overall objective: CC superimposed by…
- Conditions
- Heart Arrest, Birth Asphyxia, Bradycardia
- Trial name
- SURV1VE (NCT02858583)
- Testing
- CC+SI, 3:1 C:V
- Where
- 4 sites in Austria, Canada
- Volunteers
- 27 people
- Sponsor
- University of Alberta
Swallowing Disorder, Perinatal Asphyxia
Effect of Non-nutritive Sucking on Transition to Oral Feeding in Infants With Asphyxia
The transition period to full oral feeding in infants with perinatal asphyxia is important in predicting long-term outcomes. The transition to independent oral feeding is accepted as a discharge criterion by the American Academy…
- Conditions
- Swallowing Disorder, Perinatal Asphyxia, Feeding; Difficult, Newborn, Feeding Disorder of Infancy or Early Childhood
- Trial name
- NCT05687708
- Testing
- Non-Nutritive Sucking
- Where
- Turkey (Türkiye)
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Medipol University
Asphyxia Neonatorum, Birth Asphyxia
Augmented Infant Resuscitator (AIR): Transitioning a Novel Behavior Change Innovation to Drive Newborn Ventilation Skills Enhancement
Augmented Infant Resuscitator (AIR) is an inexpensive add-on, compatible with nearly every existing bag-valve mask and many types of ventilation equipment.
- Conditions
- Asphyxia Neonatorum, Birth Asphyxia, Perinatal Asphyxia
- Trial name
- NCT05349175
- Testing
- Augmented Infant Resuscitator (AIR)
- Where
- United States
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
Newborn Morbidity, Newborn Asphyxia
Cluster Randomized Controlled Trial Applying Helping Baby Breathe in Nepal
The cluster randomized controlled trial will be conducted in the selected health facilities/birthing centers of Sarlahi district in Nepal. Further from the selected health facilities.
- Conditions
- Newborn Morbidity, Newborn Asphyxia, Delivery Preterm
- Trial name
- SaLiN (NCT06213207)
- Testing
- Simulator based training to manage asphyxia and essential newborn care using neonatalie
- Where
- Nepal
- Volunteers
- 95 people
- Sponsor
- Integrated Development Foundation Nepal
Asphyxia Neonatorum, Morbidity;Newborn
Effects of Probiotic Mixture Supplementation and Evaluation of Intestinal Mucosal Tolerance and Gut Microbiome in Newborns With Perinatal Asphyxia Receiving Hypothermic Treatment
The VISNAT trial is a PILOT STUDY due to absence of previous evidences in literature on using probiotic in newborns with perinatal asphyxia.
- Trial name
- VISNAT (NCT04145713)
- Testing
- Probiotic mixture
- Where
- Italy
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Policlinico Hospital
Heart; Arrest, Newborn, Birth Asphyxia
Does Higher (100% Oxygen) Versus Lower (21% Oxygen) During CC+SI During CPR of Asphyxiated Newborns Improve Time to ROSC
When newborn babies are born without a heartbeat the clinical team has to provide breathing and chest compressions (what is call cardiopulmonary resuscitation) to the newborn baby.
- Conditions
- Heart; Arrest, Newborn, Birth Asphyxia, Bradycardia Neonatal
- Trial name
- SURV1VE-O2 (NCT03902652)
- Testing
- Intervention (21% oxygen during CC+SI), Intervention (100% oxygen during CC+SI)
- Where
- Canada
- Sponsor
- University of Alberta
Postpartum Hemorrhage, Neonatal Asphyxia
Saving Lives at Birth in Uganda: Building and Sustaining Capacity of Frontline Health Workers - A Program Evaluation
The study aims are to evaluate the impact of supportive follow-up strategies for a novel twinned training and capacity-sustaining program among frontline health workers (providers) attending facility-based births in remote and…
- Trial name
- NCT03254628
- Testing
- Helping Mothers Survive - Bleeding After Birth training, Helping Babies Breathe, Mentor
- Volunteers
- 3,440 people
- Sponsor
- Jhpiego
Hypoxic-Ischemic Encephalopathy, Asphyxia
Hydrocortisone Treatment In Systemic Low Blood Pressure During Hypothermia in Asphyxiated Newborns
This is a prospective, randomized, double-blind, placebo controlled, single center study to compare low dose hydrocortisone vs placebo in systemic low blood pressure during hypothermia treatment in asphyxiated newborns.
- Trial name
- CORTISoL (NCT02700828)
- Testing
- Hydrocortisone
- Where
- Hungary
- Volunteers
- 32 people
- Sponsor
- Semmelweis University
Encephalopathy, Erythropoietin
Erythropoietin for Neonatal Encephalopathy in LMIC (EMBRACE Trial)
One million babies die, and at least 2 million survive with lifelong disabilities following neonatal encephalopathy (NE) in low and middle-income countries (LMICs), every year.
- Conditions
- Encephalopathy, Erythropoietin, Newborn Asphyxia
- Trial name
- EMBRACE (NCT05395195)
- Testing
- Erythropoietin, Supportive neonatal intensive care
- Where
- 10 sites in Bangladesh, India and 1 more
- Volunteers
- 504 people
- Sponsor
- Imperial College London
Hypoxic-Ischemic Encephalopathy, Birth Asphyxia
Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries Developmental Follow Up
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…
- Trial name
- CORDMILK-FU (NCT03682042)
- Testing
- Umbilical Cord Milking
- Where
- 9 sites in India
- Volunteers
- 3,442 people
- Sponsor
- Nemours Children's Clinic
Asphyxia Neonatorum, Birth Asphyxia
Augmented Infant Resuscitator to Enhance Newborn Ventilation
Augmented Infant Resuscitator (AIR) is an inexpensive add-on, compatible with nearly every existing bag-valve mask and many types of ventilation equipment.
- Conditions
- Asphyxia Neonatorum, Birth Asphyxia, Perinatal Asphyxia
- Trial name
- AIR (NCT04820504)
- Testing
- Augmented Infant Resuscitator (AIR), AIR device without feedback
- Volunteers
- 270 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
Preterm Birth, Low Birth Weight
Perinatal Conditions Influencing Morbidity, Mortality, and Medical Care in Newborns
This study focuses on understanding the conditions that affect newborn health and survival from pregnancy to the first weeks of life at the Isidro Ayora Hospital.
- Conditions
- Preterm Birth, Low Birth Weight, Intrauterine Growth Restriction (IUGR), Perinatal Asphyxia
- Trial name
- UCE (NCT06653374)
- Testing
- Infant, Premature
- Where
- Ecuador
- Volunteers
- 26,000 people
- Sponsor
- HOSPITAL GINECO OBSTETRICO ISIDRO AYORA
Maternal Death, Neonatal Death
Evaluating the Effects of SMS Text Messaging Support System Among Frontline Health Workers in Ghana
Introduction Maternal and neonatal mortality continue to be to be prominent public health issues in sub Saharan Africa including Ghana, with slow progress made towards attainment of Millennium Development Goals (MDG) 4 \& 5.
- Conditions
- Maternal Death, Neonatal Death, Postpartum Haemorrhage, Pre-eclampsia
- Trial name
- Accelerate (NCT02468310)
- Testing
- Maternal and neonatal emergency protocols
- Where
- Ghana
- Volunteers
- 65,831 people, healthy volunteers welcome
- Sponsor
- Hannah Brown Amoakoh
Asphyxia Neonatorum
Neonatal Resuscitation With Supraglottic Airway Trial
Mortality rates from birth asphyxia in low-income countries remain very high. Face mask ventilation (FMV) is the most common method of resuscitating neonates in such settings.
- Trial name
- NeoSupra (NCT03133572)
- Testing
- Supraglottic airway, Face-mask
- Where
- Uganda
- Volunteers
- 1,163 people
- Sponsor
- Centre For International Health
Birth Asphyxia, Very Low Birth Weight Baby
Naushero Feroze Neonatal Survival Project
The present study will be carried out in close collaboration with the National Program for Lady Health Workers, a Ministry of Health program with 100,000 Lady Health Workers covering 60% of the rural population of Pakistan.
- Conditions
- Birth Asphyxia, Very Low Birth Weight Baby, Neonatal Sepsis
- Trial name
- AKU (NCT01350765)
- Testing
- Intervention, Control
- Where
- Pakistan
- Volunteers
- 37,201 people, healthy volunteers welcome
- Sponsor
- Aga Khan University
Infant Development, Sensory Disorder
The Prechtl's General Movement Assessment, Hammersmith Infant Neurological Examination and Sensory Profile-2
In the Neonatal Intensive Care Unit (NICU), infants encounter many sensory stimuli (excessive noise, bright lights, painful medical applications, etc.) that are not present in the uterus.
- Conditions
- Infant Development, Sensory Disorder, Sensory Processing Disorder, Motor Delay
- Trial name
- highrisk (NCT05217199)
- Testing
- Measurements
- Where
- Turkey (Türkiye)
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Kahramanmaras Sutcu Imam University
Hypoxic-Ischemic Encephalopathy
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of RLS-0071 in Newborns With Moderate or Severe Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia
Hypoxic-ischemic encephalopathy (HIE) affects approximately 4,000 to 12,000 persons annually in the United States. Mortality from HIE has been reported up to 60%, with at least 25% of survivors left with significant…
- Trial name
- STAR (NCT05778188)
- Testing
- RLS-0071
- Where
- 15 sites in United States
- Volunteers
- 70 people
- Sponsor
- ReAlta Life Sciences, Inc.
Sepsis, Pneumonia
Improved Accessibility of EmONC Services for Maternal and Newborn Health: a Community Based Project
The purpose of this study is to determine whether an integrated EmONC package (community mobilization, training of community-based health care providers and a maternal and neonatal health pack) reduce perinatal and neonatal…
- Conditions
- Sepsis, Pneumonia, Omphalitis, Birth Asphyxia
- Trial name
- EmONC (NCT01751945)
- Testing
- EmONC package
- Where
- Pakistan
- Volunteers
- 12,000 people, healthy volunteers welcome
- Sponsor
- Aga Khan University