Clinical trials: Infant Asphyxia
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
Asphyxia
Resuscitation of Late-preterm Infants by Using Room Air or 100% Oxygen
In this randomized control trial, the investigators hypothesize that late-preterm infants resuscitated with a "low oxygen delivery" strategy (initiation of resuscitation with room air) will result in a significant reduction in…
- Trial name
- NCT01305031
- Testing
- Resuscitation, 100% oxygen
- Where
- China
- Volunteers
- 70 people
- Sponsor
- Nanjing Medical University
Neonatal Encephalopathy
CoolCap Followup Study-Coordination of Participating Centers
This observational study will assess long-term functional outcome of survivors from neonatal encephalopathy who were previously treated with either head cooling or with conventional care in a randomized clinical trial.
- Trial name
- NCT00581581
- Where
- United States
- Volunteers
- 62 people
- Sponsor
- University of Rochester
Neonatal Asphyxia
Asphyxia at Birth : Causes and Neonatal Outcome
This is an historic cohort study based on the birth and delivery register of the HFME maternity ward. This study aim at understanding the evolution of asphyxia at birth, at all gestational ages, identifying causes and describing…
- Trial name
- ABC-NEO (NCT03227536)
- Where
- France
- Volunteers
- 61,448 people
- Sponsor
- Hospices Civils de Lyon
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
Hypoxic-Ischemic Encephalopathy, Pain
The Effect of Maternal Scent and Knitted Octopus Application on Pain in Infants Diagnosed With Neonatal Asphyxia and Receiving Therapeutic Hypothermia Treatment
This study was designed to determine the effects of maternal scent and knitted octopus application on pain in infants born with asphyxia beyond 36 weeks' gestation and receiving Therapeutic Hypothermia (TH) treatment in the…
- Trial name
- Pain in HIE (NCT07526233)
- Testing
- scent
- Where
- Turkey (Türkiye)
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Alev Sivasli
Neonatal Asphyxia, Intrapartum Fetal Distress
Intrapartum Sildenafil in Laboring Mothers
The goal of this feasibility pilot clinical trial is to learn if sildenafil citrate 50mg orally, up to three times during labor, can be appropriately administered, with limited clinical side effects, to laboring mothers to…
- Conditions
- Neonatal Asphyxia, Intrapartum Fetal Distress, Development, Infant, Intrapartum Asphyxia
- Trial name
- PRISM (NCT06377098)
- Testing
- Sildenafil 50 mg Oral Tablet
- Where
- 3 sites in Cameroon, Kenya and 1 more
- Sponsor
- University of Alabama at Birmingham
Hypoxia Neonatal, Premature
Pulse Oximetry Measurement and Transfusions
The primary purpose of this observational study was to determine if pRBC transfusions decrease the frequency of intermittent hypoxia events in very low birth weight infants (VLBW) during the first six weeks of life.
- Conditions
- Hypoxia Neonatal, Premature, Blood Transfusion
- Trial name
- POMAT (NCT04249193)
- Testing
- Transfusion
- Where
- 3 sites in United States
- Volunteers
- 75 people
- Sponsor
- Christiana Care Health Services
Hypoxic-Ischemic Encephalopathy, Cell Damage
Use of Melatonin for Neuroprotection in Asphyxiated Newborns
Protection of brain development is a major aim in the Neonatal Intensive Care Unit. Hypoxic-Ischemic Encephalopathy (HIE) occurs in 3-5 per 1000 births. Only 47% of neonates have normal outcomes.
- Conditions
- Hypoxic-Ischemic Encephalopathy, Cell Damage, Asphyxia Perinatal
- Trial name
- MELPRO (NCT03806816)
- Testing
- Melatonin
- Where
- 6 sites in Holy See, Italy
- Volunteers
- 100 people
- Sponsor
- University Hospital of Ferrara
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
Birth Asphyxia, Neonatal Resuscitation
The Baby-Saver Kit: Clinical Testing of a Device for Neonatal Resuscitation With Intact Cord in Uganda
To examine the usability, safety and acceptability of the BabySaver kit: a novel device for neonatal resuscitation in a low-income region in Africa
- Conditions
- Birth Asphyxia, Neonatal Resuscitation, Maternal Distress
- Trial name
- BabySaver (NCT03885492)
- Where
- Uganda
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Sanyu Africa Research Institute
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.
Cerebral Palsy, Infant Development
Associations Between General Movements Assessments and Cognitive Development
High risk infant is defined as infant with a negative history of environmental and biological factors, which can lead to neuromotor development problems.
- Conditions
- Cerebral Palsy, Infant Development, Cognitive Dysfunction, Cognitive Developmental Delay
- Trial name
- GMs (NCT05217056)
- Testing
- measurements
- Where
- Turkey (Türkiye)
- Volunteers
- 63 people
- Sponsor
- Kahramanmaras Sutcu Imam University
Perinatal Mortality
Global Network Implementation of Helping Babies Breathe (HBB)
The primary purpose of this pre-post evaluation is to test the impact on perinatal mortality (fresh stillbirths or early neonatal deaths) among births > 1500g of training birth attendants at health facilities in the Helping…
- Trial name
- NCT01681017
- Testing
- HBB/ENC Training and Equipment, HBB/ENC supplies
- Where
- 3 sites in India, Kenya
- Volunteers
- 70,704 people
- Sponsor
- NICHD Global Network for Women's and Children's Health
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
Death, Neurodevelopmental Impairment
Apgar-Score in Asphyxiated Infants Under Resuscitation
The specified Apgar-Score in combination with the AAP-Score predicts the morbidity and mortality of asphyxiated newborns.
- Trial name
- NCT01193751
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- Technische Universität Dresden
Infant, Newborn, Hypoxia, Brain
Late Hypothermia for Hypoxic-Ischemic Encephalopathy
This study is a randomized, placebo-controlled, clinical trial to evaluate whether induced whole-body hypothermia initiated between 6-24 hours of age and continued for 96 hours in infants ≥ 36 weeks gestational age with…
- Conditions
- Infant, Newborn, Hypoxia, Brain, Hypoxia-Ischemia, Brain, Encephalopathy, Hypoxic-Ischemic
- Trial name
- NCT00614744
- Testing
- Hypothermia, Normothermic Control
- Where
- 22 sites in United States
- Volunteers
- 168 people
- Sponsor
- NICHD Neonatal Research Network
Hypoxic Encephalopathy, Birth Asphyxia
Passive Cooling Versus Blanket-Roll III on The Myocardial Function of Asphyxiated Neonates
Studying the effect of passive versus Blanket roll III modality of therapeutic hypothermia (TH)on myocardial function of asphyxiated neonates through using tissue Doppler (TD).
- Conditions
- Hypoxic Encephalopathy, Birth Asphyxia, Neonatal Encephalopathy, Hypothermia, Newborn
- Trial name
- NCT05652738
- Testing
- Passive cooling application, cooling using Blanket roll III
- Where
- Egypt
- Volunteers
- 100 people
- Sponsor
- Alexandria University
Cerebral Palsy, Reliability
Turkish Validity And Reliability Of The Hammersmith Infant Neurological Evaluation (Hine)
The high risk of infants are defined as having a negative environmental and biological factor history, where these factors can lead to neuromotor development problems.
- Conditions
- Cerebral Palsy, Reliability, Infant Development, Infant, Premature, Diseases
- Trial name
- Hine (NCT04259177)
- Testing
- Scale
- Where
- Turkey (Türkiye)
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Sanko University
Birth Asphyxia
Finding Solutions to Thrive After Birth Asphyxia in Africa
Neonatal encephalopathy (NE) is the third leading cause of under 5-year mortality and contributes substantially to long-term neurological morbidity worldwide.
- Trial name
- SANE-Uganda (NCT05275725)
- Testing
- Sildenafil
- Where
- Uganda
- Volunteers
- 18 people
- Sponsor
- Pia Wintermark