Clinical trials: Hypothermia Neonatal
Infant, Premature, Hypothermia, Newborn
Cardboard Cot in Neonatal Thermoregulation: A Randomized Cross Over Trial
This study will determine whether the efficacy of Mylar-lined cardboard cots is equivalent to traditional incubators in their ability to prevent hypothermia (axillary temperature < 36° C) in preterm neonates <36 6/7 weeks…
- Trial name
- CCot (NCT03344978)
- Testing
- Cardboard Cot Care, Incubator Care
- Sponsor
- University of Alabama at Birmingham
Thermoregulation Impairment, Hypothermia
Incidence and Prevention of Hypothermia in Newborns Bonding During Caesarean Section
This study should evaluate whether newborns during cesarean section are endangered to get hypothermic while bonding on the mothers chest.
- Conditions
- Thermoregulation Impairment, Hypothermia, Postoperative Shivering
- Trial name
- THER5 (NCT01793558)
- Testing
- Forced-air warming
- Where
- Germany
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- University Hospital Schleswig-Holstein
Neonatal Hypothermia
Effect of a Servo-control System on Heat Loss in Very Low Birth Weight Infants at Birth
Hypothermia in preterm infants during the immediate postnatal phase is associated with morbidity and mortality and remains an unresolved, worldwide challenge.
- Trial name
- SCOPRI (NCT03844204)
- Testing
- Thermal servo-controlled system
- Where
- Italy
- Volunteers
- 440 people
- Sponsor
- University Hospital Padova
Thermoregulation, Neonatal Hypothermia
Effect of Thermoregulation Bundle Applied at Birth on Neonatal Physiological Parameters and Breastfeeding
Maintaining neonatal body temperature (thermoregulation), particularly during the first hour after birth, is critical for survival and successful adaptation to the extrauterine environment.
- Conditions
- Thermoregulation, Neonatal Hypothermia, Neonatal Adaptation
- Trial name
- NCT07453264
- Testing
- Thermoregulation bundle, routine care
- Where
- Turkey (Türkiye)
- Volunteers
- 140 people
- Sponsor
- Istanbul University - Cerrahpasa
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
Newborn, Infant
Placing Preterm Infants in Polyethylene Bags Immediately After Birth
Primary objective: To determine if placing preterm infants in a polyethylene bag (PB) immediately after birth, before the umbilical cord is clamped, will increase the number of preterm infants with a normal temperature on…
- Conditions
- Newborn, Infant, Hypothermia, Premature
- Trial name
- NCT04463511
- Testing
- Polyethylene bag before the umbilical cord is clamped
- Where
- Ireland
- Volunteers
- 194 people, healthy volunteers welcome
- Sponsor
- University College Dublin
Ischemic-Hypoxic Encephalopathy
Long Term Prognostic of Neonatal Hypoxic Ischemic Encephalopathy With Hypothermia Treatment
The primary objective is to evaluate neonatal characteristics, and biological and clinical investigations as predictive factors of death, or of severe and moderate neurodevelopmental disability at 3 years, in a large…
- Trial name
- LyTONEPAL (NCT02676063)
- Where
- 22 sites in France
- Volunteers
- 800 people
- Sponsor
- University Hospital, Grenoble
Neonatal Respiratory Failure
Hypothermia During ECMO to Decrease Brain Injury
Newborn infants with severe respiratory failure are treated with extracorporeal membrane oxygenation (ECMO), a modified form of cardiopulmonary bypass.
- Trial name
- NCT01675388
- Testing
- Hypothermia
- Where
- United States
- Sponsor
- Sood, Beena G., MD, MS
Neonatal Hypothermia
Evaluation of a Novel Neonatal Temperature Monitor
A team of researchers at Rice University and Queen Elizabeth Central Hospital (QECH) are working to develop a low-cost temperature sensor that can continuously monitor an infant's temperature (NTM).
- Trial name
- NCT03866122
- Testing
- NTM Monitoring
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- William Marsh Rice University
Hypoxic-Ischemic Encephalopathy
A Study of a Blood Marker in Newborns With Brain Injury Caused by Lack of Oxygen at Birth
Perinatal asphyxia is a significant health problem with an incidence of 1 to 8 per 1,000 live births and can lead to serious morbidity and mortality during the neonatal period.
- Trial name
- NCT07292220
- Where
- Turkey (Türkiye)
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Mustafa Gürkan
Therapeutic Hypothermia, Neonatal Hypoxic-Ischemic Encephalopathy
Continuous Monitoring of Body Temperature in Neonates During Therapeutic Hypothermia
This prospective observational pilot study aims to evaluate the feasibility, accuracy, and safety of the SteadyTemp® wireless adhesive thermometer for continuous, non-invasive body temperature monitoring in neonates undergoing…
- Conditions
- Therapeutic Hypothermia, Neonatal Hypoxic-Ischemic Encephalopathy, Neonatal Thermal Management
- Trial name
- MonT HT (NCT07756892)
- Testing
- continous temperature measurement
- Where
- Austria
- Volunteers
- 10 people
- Sponsor
- Medical University of Graz
Neonatal Encephalopathy
Magnetic Resonance Biomarkers in Neonatal Encephalopathy
N-acetylaspartate (NAA) is a surrogate neuronal marker and its proton magnetic resonance spectroscopy (1H MRS) signal decreases with increasing neuronal mortality associated with cerebral hypoxia-ischaemia.
- Trial name
- MARBLE (NCT01309711)
- Where
- United Kingdom
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Imperial College London
Hypoxic Ischemic Brain Injury, Neonatal Encephalopathy
Dexmedetomidine Versus Morphine During Cooling Therapy in Neonates
About ~3/ 1000 live-born newborns may suffer from brain injury due to a transient drop in oxygen supply to the brain during the birth process.
- Conditions
- Hypoxic Ischemic Brain Injury, Neonatal Encephalopathy, Perinatal Anoxic-ischemic Brain Injury
- Trial name
- COOL-SED (NCT06985290)
- Testing
- Dexmedetomidine Infusion, Morphine Infusion
- Where
- Canada
- Volunteers
- 50 people
- Sponsor
- Ipsita Goswami
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
Newborn Hypothermia
A Study of Effects of Delay in the First Bathing Time of Body Temperature and the Rate of Exclusive Breastfeeding
Using delaying the first bathing by 8 hours as an interventional measure, considering the consistent effect of physiological maturity, newborns with a gestational age of ≥37 weeks were selected as the subjects in the nursery…
- Trial name
- NCT05425394
- Testing
- Delay first bath
- Where
- Taiwan
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Cardinal Tien Hospital
Infant, Newborn, Hypoxia, Brain
Preemie Hypothermia for Neonatal Encephalopathy
This study is a randomized, controlled trial to assess safety and effectiveness of whole body hypothermia for 72 hours in preterm infants 33-35 weeks gestational age (GA) who present at <6 hours postnatal age with moderate to…
- Conditions
- Infant, Newborn, Hypoxia, Brain, Hypoxia-Ischemia, Brain, Encephalopathy, Hypoxic-Ischemic
- Trial name
- NCT01793129
- Testing
- Hypothermia, Normothermic Control
- Where
- 18 sites in United States
- Volunteers
- 168 people
- Sponsor
- NICHD Neonatal Research Network
Hypothermia
Evaluation of Use of Plastic Bags to Prevent Neonatal Hypothermia-Part IV
The overall hypothesis is that plastic bags used in combination with WHO thermoregulation care will reduce the incidence of hypothermia in preterm/low birth weight and full term infants when compared to routine WHO…
- Trial name
- NCT01604447
- Testing
- Hypothermia prevention with plastic bag, Hypothermia prevention without plastic bag
- Where
- Zambia
- Volunteers
- 118 people
- Sponsor
- University of Alabama at Birmingham
Hypothermia, Newborn
Evaluation of Use of Plastic Bags to Prevent Neonatal Hypothermia-Part V
The overall hypothesis is that plastic bags used in combination with WHO thermoregulation care will reduce the incidence of hypothermia in preterm/low birth weight and full term infants when compared to routine WHO…
- Trial name
- NCT01604460
- Testing
- Resuscitation with torso plastic bag, Resuscitation-no plastic bag
- Where
- Zambia
- Volunteers
- 275 people
- Sponsor
- University of Alabama at Birmingham
Neonatal Encephalopathy
Transcutaneous Carbon Dioxide Monitoring in Neonates Receiving Therapeutic Hypothermia for Neonatal Encephalopathy
The aim of our study is to evaluate the feasibility of applying transcutaneous CO2 monitoring (tcPCO2) in neonates receiving therapeutic hypothermia and to quantify the agreement between tcPCO2 and PCO2 in this population with or…
- Trial name
- NCT04603547
- Testing
- Transcutaneous Carbon Dioxide Monitoring
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- Brigham and Women's Hospital
Neonatal Hypoxic-Ischemic Encephalopathy (HIE)
CoolCap Trial, Treatment of Perinatal Hypoxic-Ischemic Encephalopathy
This is a research study of head cooling. Its goal is to determine whether cooling babies' heads can reduce or prevent brain damage that may have resulted from temporarily reduced oxygen supply to the brain.
- Trial name
- NCT00383305
- Testing
- Cool-Cap
- Where
- 27 sites in United States, Canada and 2 more
- Volunteers
- 235 people
- Sponsor
- Olympic Medical