Clinical trials: Newborn Asphyxia
Birth Asphyxia
Sildenafil to Repair Brain Injury Secondary to Birth Asphyxia
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.
- Trial name
- SANE-02 (NCT04169191)
- Testing
- Sildenafil Citrate
- Where
- Canada
- Volunteers
- 20 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Hypoxia Neonatal
Owlet Smart Sock 3 Accuracy on Infants
The purpose of this research study is to evaluate the Owlet Smart Sock 3 wireless pulse oximeter performance in assessing the heart rate and oxygen saturation in neonatal population, while measuring the same parameter with a…
- Trial name
- NCT05635513
- Testing
- Owlet OSS V3
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Owlet Baby Care, Inc.
Hypoxic-Ischemic Encephalopathy, Birth Asphyxia
Umbilical Cord Milking in Neonates Who Are Depressed at Birth-Developmental Follow Up (MIDAB-FU)
An extension of the MIDAB trial, the MIDAB-Follow-up trial will evaluate the neurodevelopmental outcomes at 22-26 months age of term/late preterm infants who were depressed at birth and received umbilical cord milking (UCM) or…
- Trial name
- MIDAB-FU (NCT03681314)
- Testing
- Umbilical Cord Milking
- Where
- 3 sites in India
- Sponsor
- Nemours Children's Clinic
Neonatal Hypoxia
Citicoline as Neuroprotector in Neonates Exposed to Hypoxia
Citicoline as neuroprotector in neonates exposed to hypoxia: A randomized controlled trial
- Trial name
- NCT03949049
- Testing
- Citicoline
- Where
- Egypt
- Volunteers
- 40 people
- Sponsor
- Sherief Abd-Elsalam
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
Hypoxic-Ischaemic Encephalopathy, Neonatal Encephalopathy
Intranasal Breast Milk Therapy in HIE
This is an open-label prospective single-center randomized controlled trial to evaluate the effect of intranasal breast milk in hypoxic-ischemic encephalopathic neonates receiving therapeutic hypothermia on long term…
- Conditions
- Hypoxic-Ischaemic Encephalopathy, Neonatal Encephalopathy, Perinatal Asphyxia, Neonatal Hypoxic Ischemic Encephalopathy
- Trial name
- NEO-BRIGHT (NCT06746532)
- Testing
- Intranasal breast milk
- Where
- Hungary
- Volunteers
- 80 people
- Sponsor
- Semmelweis University
Hypoxic-Ischemic Encephalopathy, Neonatal Asphyxia
Assess Safety and Efficacy of Sovateltide in Hypoxic-ischemic Encephalopathy
Sovateltide (PMZ-1620; IRL-1620) is targeted to be used as a "Treatment for hypoxic-ischemic encephalopathy in neonates," which is a life-threatening condition.
- Conditions
- Hypoxic-Ischemic Encephalopathy, Neonatal Asphyxia, Neonatal Encephalopathy
- Trial name
- NCT05514340
- Testing
- Normal Saline along with standard treatment, Sovateltide along with standard treatment
- Where
- 4 sites in India
- Volunteers
- 40 people
- Sponsor
- Pharmazz, Inc.
Hypoxic-Ischemic Encephalopathy, Acute Kidney Injury
Renal and Cerebral NIRS and Early Acute Kidney Injury in Cooled Neonates With Birth Asphyxia
This prospective, single-center observational cohort study evaluated whether continuous cerebral and bilateral renal near-infrared spectroscopy (NIRS) monitoring during therapeutic hypothermia distinguishes term neonates with…
- Conditions
- Hypoxic-Ischemic Encephalopathy, Acute Kidney Injury, Hypoxic-Ischemic Encephalopathy, Neonatal, Asphyxia Neonatorum
- Trial name
- NCT07743099
- Testing
- 1- Continuous Cerebral Near-Infrared Spectroscopy, 2- Continuous Bilateral Renal Near-Infrared Spectroscopy
- Where
- Turkey (Türkiye)
- Volunteers
- 46 people
- Sponsor
- Agah Bahadır Öztürk,MD
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
Birth Asphyxia
First-day High Dose Vitamin C, E in Severe Birth Asphyxia
To study the role of first-day high dose oral vitamin C and first-day single high dose oral vitamin E in hypoxic-ischemic encephalopathy in newborns, in the reduction of morbidity and adverse neurodevelopmental sequelae.
- Trial name
- CEBA (NCT01743742)
- Testing
- Vitamin E, Vitamin C
- Where
- India
- Volunteers
- 95 people
- Sponsor
- Sir Takhtasinhji General Hospital
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
Hypoxic-ischemic Encephalopathy
Neonatal Erythropoietin in Asphyxiated Term Newborns
The purpose of this study is to determine the safety and pharmacokinetics of moderate to high doses of erythropoietin in newborn infants with birth asphyxia.
- Trial name
- NEAT (NCT00719407)
- Testing
- erythropoietin
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- University of California, San Francisco
Sudden Unexplained Infant Death, Apnea of Newborn
Advanced Wireless Sensors for Neonatal Care in the Delivery Room
The goals of this observational study is to assess whether a new advanced wireless skin sensor vital sign monitoring system can effectively monitor the vital signs of healthy newborn infants (≥ 35 weeks gestational age).
- Conditions
- Sudden Unexplained Infant Death, Apnea of Newborn, Newborn Morbidity, Newborn Asphyxia
- Trial name
- AWARD (NCT06693817)
- Testing
- Wireless skin sensors vital sign monitoring system, Wired vital sign monitoring system
- Where
- 5 sites in Brazil, Canada and 2 more
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Guilherme Sant'Anna, MD
Mortality
Lufwanyama Neonatal Survival Project
We seek to determine whether we can reduce day 28 mortality in Zambian newborns by training traditional birth attendants a modified version of the neonatal resuscitation protocol (NRP) and by improving their abiltiy to identify…
- Trial name
- LUNESP (NCT00518856)
- Testing
- Neonatal resuscitation protocol, Standard of care
- Volunteers
- 3,559 people, healthy volunteers welcome
- Sponsor
- Boston University
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
Infant, Newborn, Hypoxia, Brain
Optimizing (Longer, Deeper) Cooling for Neonatal Hypoxic-Ischemic Encephalopathy(HIE)
The Optimizing Cooling trial will compare four whole-body cooling treatments for infants born at 36 weeks gestational age or later with hypoxic-ischemic encephalopathy: (1) cooling for 72 hours to 33.5°C; (2) cooling for 120…
- Conditions
- Infant, Newborn, Hypoxia, Brain, Hypoxia-Ischemia, Brain, Encephalopathy, Hypoxic-Ischemic
- Trial name
- NCT01192776
- Testing
- Whole-body Cooling
- Where
- 19 sites in United States
- Volunteers
- 364 people
- Sponsor
- NICHD Neonatal Research Network
Hypoxic-Ischemic Encephalopathy, Hypoxia Neonatal
Feasibility and Safety of Umbilical Cord Blood Transfusion in the Treatment of Neonatal Cerebral Ischemia and Anemia
The study is to investigate the feasibility and safety of autologous umbilical cord blood transfusion to treat the newborn infants with presence of clinical indications of neonatal hypoxic-ischemia encephalopathy (HIE) and…
- Conditions
- Hypoxic-Ischemic Encephalopathy, Hypoxia Neonatal, Cerebral Ischemia of Newborn, Anemia, Neonatal
- Trial name
- NCT03352310
- Testing
- autologous umbilical cord blood (UCB), standard care
- Where
- Hong Kong
- Volunteers
- 40 people
- Sponsor
- Mononuclear Therapeutics Ltd.
Neonatal Encephalopathy, Cell Damage
Inflammation and Metabolic Acidosis at Birth (AGAIN: AutophaGy AcIdosis Newborn)
Protection of brain development is a major aim in the Neonatal Intensive Care Unit. Neonatal encephalopathy (NE) occurs in 1.8 to 7.7 infants per 1000 births.
- Conditions
- Neonatal Encephalopathy, Cell Damage, Metabolic Acidosis, Inflammation
- Trial name
- AGAIN (NCT03897101)
- Where
- 2 sites in Italy
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- University Hospital of Ferrara
Infant, Premature, Diseases, Congenital Abnormalities
Esophageal Motility and Airway Defenses Among Infants
Feeding difficulties and airway related consequences contribute significantly to the infant mortality and morbidity. Some of these problems may be dependent on neural control and muscular function.
- Conditions
- Infant, Premature, Diseases, Congenital Abnormalities, Perinatal Asphyxia
- Trial name
- NCT00062452
- Where
- United States
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)