Clinical trials: Hypothermia, Newborn
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
Hypoxic Ischemic Encephalopathy, Cerebral Infarction
Neuroprotective Effect of Autologous Cord Blood Combined With Therapeutic Hypothermia Following Neonatal Encephalopathy
This study examines the effect of cord blood in the treatment of newborn infants with neonatal encephalopathy in combination with hypothermia, which is the standard treatment for this condition.
- Trial name
- NCT02551003
- Testing
- Autologous cord blood, Hypothermia
- Where
- China
- Sponsor
- Children's Hospital of Fudan University
Newborn; Hyperthermia
Randomised Controlled Trial on Using Active Warming to Prevent Newborn Hypothermia After Caesarean Delivery
Despite the enormous advantages that skin-to-skin contact (STSC) and Delaying Cord Clamping (DCC) bring, newborns can lose heat quickly if they are not thermally protected.
- Trial name
- NCT06532266
- Testing
- TechTrade Ready Heat Half Body Temperature Management Blankets, Control
- Where
- China
- Volunteers
- 120 people
- Sponsor
- The University of Hong Kong
Hypoxic-Ischemic Encephalopathy
Safety and Efficacy of Hypothermia to Treat Neonatal Hypoxic-Ischemic Encephalopathy
The purpose of this study is to investigate the effectiveness and safety of selective head cooling (SHC) in neonatal hypoxic-ischemic encephalopathy (HIE).
- Trial name
- NCT00890409
- Testing
- Cooling cap (YJW608-04B)
- Where
- China
- Volunteers
- 256 people
- Sponsor
- Fudan University
Anesthesia; Hypothermia, Congenital Heart Disease
Evaluation of a Novel Patient Warming System During MRI
Patients under deep sedation and general anesthesia lose heat to their surrounding environment. Hypothermia after anesthesia is associated with worse patient outcomes, including increased number of infections and cardiovascular…
- Trial name
- NCT03150953
- Testing
- MRI-safe bore covering
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Andrew Matisoff
Asphyxia Neonatorum, Hypoxia
TOBY (TOtal Body hYpothermia): a Study of Treatment for Perinatal Asphyxia
Hypothesis: Prolonged whole body cooling in term infants with perinatal asphyxial encephalopathy reduces death and severe neurodevelopmental disability.
- Conditions
- Asphyxia Neonatorum, Hypoxia, Encephalopathy, Seizures
- Trial name
- NCT00147030
- Testing
- Whole body mild induced hypothermia
- Where
- United Kingdom
- Volunteers
- 325 people
- Sponsor
- Imperial College London
Preterm Birth, Hypothermia, Newborn
Kangaroo Mother Care With Plastic Bag (Trials 1A & 1B)
The purpose of this study is to determine whether the combination of Kangaroo Mother Care (KMC) as continuously as possible together with the use of a plastic bag in combination with routine World Health Organization (WHO)…
- Trial name
- NCT03141736
- Testing
- KMC & WHO protocol (0-1 hour), KMC, WHO protocol & bag (0-1 hour), KMC & WHO protocol (1-24 hours)
- Sponsor
- University of Alabama at Birmingham
Hypoxic-Ischemic Encephalopathy Mild, Neonatal Encephalopathy
TIME Study: Therapeutic Hypothermia for Infants With Mild Encephalopathy
The TIME study is a randomized, controlled trial to evaluate impact on early measures of neurodevelopment and the safety profile of therapeutic hypothermia in term neonates with Mild Hypoxic-Ischemic Encephalopathy who are < 6…
- Trial name
- TIME (NCT04176471)
- Testing
- Therapeutic Hypothermia, Normothermia
- Where
- 5 sites in United States
- Volunteers
- 68 people
- Sponsor
- Stanford University
Congenital Heart Disease, Hypoplastic Left Heart Syndrome
Cold Heart Study: A Randomized Pilot Trial of Surfactant Therapy
This clinical trial is being done to see if giving surfactant (Curosurf®) will decrease the number of days that infants will need a breathing tube, decrease the days in the critical care unit and decrease the number of days…
- Trial name
- NCT04181255
- Testing
- Curosurf
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- University of Michigan
Hypothermia
Pharmacokinetics of Ampicillin in Neonates With Moderate to Severe Hypoxic-Ischemic Encephalopathy
Controlled Hypothermia has become the standard of care for neonates with moderate to severe HIE. Ampicillin and aminoglycosides are drugs that are universally used for the treatment of suspected neonatal sepsis, which may or may…
- Trial name
- NCT03129620
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Drexel University
Preterm, Low Birthweight
Low-Cost and Reusable Thermal Jacket for Managing Preterm or Low Birth Weight Neonates.
Globally, over 15 million neonates are born preterm each year. They account for approximately 30% of global neonatal deaths and 19% of total neonatal deaths in Bangladesh.
- Conditions
- Preterm, Low Birthweight, Hypothermia Neonatal
- Trial name
- NCT06277843
- Testing
- Thermal Jacket
- Where
- Bangladesh
- Volunteers
- 10 people
- Sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
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
Kangaroo Mother Care, Preterm Infant
Kangaroo Mother Care Before Stabilisation Amongst Low Birth Weight Neonates in Africa
We will conduct an individually randomised, controlled, superiority trial with two parallel groups; an intervention arm allocated to receive KMC and a control arm receiving 'standard' care.
- Conditions
- Kangaroo Mother Care, Preterm Infant, Death; Neonatal, Hypothermia, Newborn
- Trial name
- OMWaNA (NCT02811432)
- Testing
- Kangaroo mother care, Standard care
- Where
- 4 sites in Uganda
- Volunteers
- 2,221 people
- Sponsor
- London School of Hygiene and Tropical Medicine
Hypothermia
mOm Incubator Pilot Study
The mOm Incubator is a collapsible infant incubator designed to provide a level of thermoregulation that meets the standards set for conventional incubators whilst being low cost and space-saving.
- Trial name
- NCT03450668
- Testing
- mOm incubator, standard incubator
- Where
- United Kingdom
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- mOm incubators
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
Hypothermia Neonatal, Premature Birth
Polyethylene Bag vs Prewarmed Blanket for Preventing Neonatal Hypothermia During Transfer
Premature babies can lose body heat quickly after birth, which can lead to serious health problems. This study compared two methods to keep premature babies warm while they were being moved from the delivery room to the neonatal…
- Conditions
- Hypothermia Neonatal, Premature Birth, Neonatal
- Trial name
- NCT07661511
- Testing
- Neonatal Polyethylene Bag, Prewarmed Blanket
- Where
- Mexico
- Volunteers
- 67 people
- Sponsor
- Mario Adrián Tienda Vázquez
Asphyxia Neonatorum
Fentanyl and Clonidine for Analgesia During Hypothermia in Term Asphyxiated Infants
A prospective pharmacokinetic (PK), pharmacodynamic (PD) and pharmacogenetic (PG) observation study, including the PK/PD/PG relationship, in fentanyl and clonidine administered for analgesia and sedation to term newborn…
- Trial name
- SANNI 1 (NCT03177980)
- Testing
- Fentanyl, Fentanyl and clonidine
- Where
- 2 sites in Sweden
- Volunteers
- 49 people
- Sponsor
- Region Skane
Hypothermia
Neonatal Warming to Prevent Hypothermia
Researchers are proposing a pilot randomized controlled trial evaluating the benefit of immediately warming preterm babies using a warming mattress and a plastic wrap, while delaying clamping the umbilical cord at the time of…
- Trial name
- NCT04827394
- Testing
- Neonatal warming mattress, Sterile polyethylene wrap
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- University of Oklahoma
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
Acute Kidney Injury, Hypoxic-Ischemic Encephalopathy
PK and Safety of Caffeine in Neonates With Hypoxic Ischemic Encephalopathy Receiving Therapeutic Hypothermia
A phase 1 study investigating the tolerability and pharmacokinetics of caffeine citrate in neonates with hypoxic ischemic encephalopathy receiving therapeutic hypothermia.
- Conditions
- Acute Kidney Injury, Hypoxic-Ischemic Encephalopathy, Caffeine
- Trial name
- NCT05295784
- Testing
- Caffeine citrate
- Where
- 2 sites in United States
- Sponsor
- University of Arkansas