Clinical trials: Perinatal Asphyxia
Perinatal Arterial Ischemic Stroke, Perinatal Asphyxia
Intranasal Stem Cells to Treat Perinatal Brain Injury to Combat Cerebral Palsy
Hypoxic-ischemic brain injury (HIBI) is a leading cause of death and lifelong disability in near-term and term infants, most often caused by perinatal arterial ischemic stroke (PAIS, incidence approximately 1:5000 live births) or…
- Conditions
- Perinatal Arterial Ischemic Stroke, Perinatal Asphyxia, Hypoxic-Ischemic Brain Injury, PAIS
- Trial name
- iSTOP-CP (NCT07831746)
- Testing
- MSC, marrow
- Volunteers
- 162 people
- Sponsor
- UMC Utrecht
Hypoxic-Ischemic Encephalopathy, Perinatal Asphyxia
EEG-Based Decision-Support Algorithm for Hypoxic-Ischemic Encephalopathy in Term Newborns
This retrospective, multicenter, observational study evaluates how well a decision-support algorithm can tell apart mild forms of hypoxic-ischemic encephalopathy (HIE) from moderate or severe forms in full-term newborns born…
- Conditions
- Hypoxic-Ischemic Encephalopathy, Perinatal Asphyxia, Neonatal Brain Injury
- Trial name
- COOLDECIDE (NCT07764315)
- Volunteers
- 310 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Perinatal Asphyxia
Optimization of Routine Obstetric and Neonatal Care in the Management of Severe Perinatal Asphyxia in Term or Near-term Newborns: Analysis of Sub-optimal Care
The purpose of this study is to identify and analyze suboptimal perinatal (obstetric-pediatric) care in the occurrence and management of severe perinatal asphyxia or death of the newborn at or near term.
- Trial name
- OptiNeoCare (NCT06322732)
- Where
- France
- Volunteers
- 336 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Hypoxic-Ischemic Encephalopathy, Asphyxia Perinatal
Identification of a Pool of miRNA to Improve Early Management of Perinatal Asphyxia and Hypoxic Ischemic Encephalopathy
Hypoxic-ischemic encephalopathy is the most common cause of neurological damage in the neonatal period. It has an incidence of about 1.5-2.5% of livebirths in developed countries.
- Trial name
- NCT05986994
- Testing
- Metabolic acidosis, microRNA, Hypothermia
- Where
- 2 sites in Italy
- Volunteers
- 45 people
- Sponsor
- Ospedale Buon Consiglio Fatebenefratelli
Hypothermia Neonatal, Haemodynamic Instability
Evaluation of Haemodynamic in Neonates Treated With Hypothermia"
Perinatal hypoxia in the form of hypoxic-ischaemic encephalopathy (HIE) is a frequent cause of cerebral impairment in neonates. HIE occurs in 3 to 5 of 1000 neonates in developed countries and is significantly higher in…
- Conditions
- Hypothermia Neonatal, Haemodynamic Instability, Perinatal Asphyxia
- Trial name
- NCT05574855
- Where
- 4 sites in Poland
- Volunteers
- 113 people
- Sponsor
- Princess Anna Mazowiecka Hospital, Warsaw, Poland
Shock, Preterm Birth Complication
Early Hydrocortisone Versus Regular Treatment in Shock in Extremely Preterm Neonates - an Open Randomized Controlled Trial
The goal of this clinical trial is to determine the effectiveness of early use of hydrocortisone (since the diagnosis of shock) for its resolution within the first 72 hours in premature infants under 1,500 g.
- Conditions
- Shock, Preterm Birth Complication, Preterm Intraventricular Hemorrhage, Asphyxia Perinatal
- Trial name
- NCT07248761
- Testing
- Intravascular Hydrocortisone (stress dosage): 1 mg/k/dose each 8 hours for 5 days, Vasoactive drug therapies
- Where
- Mexico
- Volunteers
- 76 people
- Sponsor
- Coordinación de Investigación en Salud, Mexico
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
Hypoxic Ischaemic Encephalopathy (HIE), Hypoxic Ischemic Encephalopathy of Newborn
Feasibility and Safety of Intranasally Administered Breast Milk in HIE
This is a prospective intervention single center study to evaluate the feasibility and safety of intranasal breast milk in hypoxic-ischaemic encephalopathic neonates receiving therapeutic hypothermia.
- Conditions
- Hypoxic Ischaemic Encephalopathy (HIE), Hypoxic Ischemic Encephalopathy of Newborn, Neonatal Encephalopathy, Neonatal Hypoxic Ischemic Encephalopathy
- Trial name
- F-NEO-BRIGHT (NCT06747260)
- Testing
- Intranasal breast milk
- Where
- Hungary
- Volunteers
- 10 people
- Sponsor
- Semmelweis University
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
Neonatal Death, Birth Asphyxia
Comparison of Virtual Training to In-Person Training of Helping Babies Breathe in Ethiopia
Helping Babies Breathe (HBB) is a program that teaches providers in low- and middle-income countries about neonatal resuscitation. Historically, HBB training was delivered in person.
- Trial name
- NCT05854745
- Testing
- HBB Virtual Training, HBB In-person Training
- Where
- Ethiopia
- Volunteers
- 262 people, healthy volunteers welcome
- Sponsor
- Stanford University
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
Perinatal Asphyxia, Hypothermia Treatment
Quantification of Brain and Kidney Perfusion Before, During, and After Hypothermia Treatment in Neonates With Perinatal Asphyxia Using Contrast-enhanced Ultrasound
In this clinical study vascular dynamics in the neonatal brain and kidney will be monitored by CUES and ULM before, during and after hypothermia treatment in neonates with asphyxia.
- Conditions
- Perinatal Asphyxia, Hypothermia Treatment, Gestational Age Min. 36SSW
- Trial name
- NCT06611254
- Testing
- Contrast enhanced ultrasound imaging (CEUS) and post processing with ULM
- Where
- Germany
- Volunteers
- 20 people
- Sponsor
- University of Erlangen-Nürnberg Medical School
Hypoxic-Ischemic Encephalopathy, Perinatal Asphyxia
Umbilical Cord Milking Versus Immediate Cord Clamping in Full Term Neonates (≥ 37 Weeks) Requiring Resuscitation
The objective of the study is to compare the incidence of Hypoxic ischemic encephalopathy (all stages) among singleton term neonates (≥ 37 weeks) requiring resuscitation who will undergo Umbilical cord milking as compared to…
- Trial name
- NCT06090968
- Testing
- Umbilical cord milking, Immediate cord clamping
- Where
- India
- Volunteers
- 200 people
- Sponsor
- Lady Hardinge Medical College
Fetal Distress, Perinatal Asphyxia
Sildenafil Citrate to Improve Maternal and Neonatal Outcomes in Low-resource Settings
The PRISM pilot feasibility study consists of two phases to determine: 1) to delivery practices, rates of primary and secondary outcomes, and feasibility of enrollment rates, and 2) to assess the feasibility and acceptability of…
- Conditions
- Fetal Distress, Perinatal Asphyxia, Birth Asphyxia, Stillbirth
- Trial name
- PRISM (NCT05946681)
- Where
- Zambia
- Volunteers
- 1,017 people, healthy volunteers welcome
- Sponsor
- NICHD Global Network for Women's and Children's Health
Pregnancy Complications, Maternal Death
Nutrition Optimalization Among Pregnant Women to Improve Maternal and Neonatal Outcome in DKI Jakarta
The goal of this MONAS Study is to learn about comprehensive monitoring and nutritional intervention among pregnant women in order to improve maternal and neonatal outcomes. The main questions it aims to answer are: 1.
- Conditions
- Pregnancy Complications, Maternal Death, Preeclampsia, Intrauterine Infection
- Trial name
- MONAS (NCT06268509)
- Testing
- Nutritional panel laboratory examination, Pregnancy supplements (other than provided by Ministry of Health), Fetomaternal ultrasound
- Where
- Indonesia
- Volunteers
- 245 people
- Sponsor
- Dr Cipto Mangunkusumo General Hospital
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
Hypoxic-Ischaemic Encephalopathy, Perinatal Asphyxia
Hypoxic-Ischemic Encephalopathy Therapy Optimization in Neonates for Better Neuroprotection With Inhalative CO2
This is a Phase I, open-label, single center trial to evaluate the feasibility and safety of low concentration CO2 gas mixture (5% CO2 + 95% air) inhalation in asphyxiated, cooled, mechanically ventilated newborns at risk of…
- Conditions
- Hypoxic-Ischaemic Encephalopathy, Perinatal Asphyxia, Hypocapnia
- Trial name
- HENRIC (NCT02700854)
- Testing
- 5% carbon-dioxide inhalation
- Where
- Hungary
- Volunteers
- 10 people
- Sponsor
- Semmelweis University
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
Perinatal Asphyxia
Determination of Heart Rate in Infants Needing Resuscitation at Birth
Algorithms for neonatal resuscitation adapted to low resource settings include HR evaluation by auscultation or umbilical cord palpation at about one minute of life.
- Trial name
- NCT03854435
- Testing
- Heart rate assessment (stethoscope), Heart assessment (umbilical cord palpation)
- Where
- 2 sites in Ethiopia, Italy
- Volunteers
- 60 people
- Sponsor
- University Hospital Padova
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