Clinical trials: Hypothermia, Newborn
Hypothermia, Newborn, Preterm Birth Complication
Umbilical or Peripheral Catheter Insertion for Preterm Infants on Admission to the NICU
Preterm infants are at risk of hypothermia following delivery and in the first few hours of life. Hypothermia in extremely low birth weight infants' is an independent risk factor for death.
- Conditions
- Hypothermia, Newborn, Preterm Birth Complication, Neonatal Hypothermia
- Trial name
- UP (NCT04761484)
- Testing
- Vascular access on admission
- Where
- Ireland
- Volunteers
- 116 people, healthy volunteers welcome
- Sponsor
- University College Dublin
Neonatal Encephalopathy, Feeding; Difficult, Newborn
OMT to Improve Feeding After Hypothermia
The goal of this study is to determine if infants with neonatal encephalopathy will achieve full oral feeds faster after therapeutic hypothermia has completed if they are treated with osteopathic manipulative treatment.
- Trial name
- NCT03380013
- Testing
- Osteopathic Manipulative Treatment (OMT)
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- MaineHealth
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
Hypothermia
Impact of Active Heating on Maternal and Neonatal Well-being
This study was conducted to determine the effects of actively warming the patient and using warmed intravenous (IV) fluid during cesarean section on maternal and infant well-being
- Trial name
- NCT06259942
- Testing
- İntervention 1 group (underbody heater group only), İntervention 2 group (group using both underbody heater and heated iv liquid), Control Group
- Where
- Turkey (Türkiye)
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- TC Erciyes University
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
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
Neonatal Asphyxial Encephalopathy, Hypoxic Ischemic Encephalopathy
Moderate Hypothermia in Neonatal Hypoxic Ischemic Encephalopathy
This study was a multicenter, randomized, controlled pilot trial of moderate systemic hypothermia (33°C) vs normothermia (37°C) for 48 hours in infants with neonatal encephalopathy instituted within 6 hours of birth or…
- Trial name
- NCT02826941
- Testing
- hypothermia, normothermia
- Volunteers
- 65 people
- Sponsor
- Medical University of South Carolina
Hypoxic-Ischemic Encephalopathy, Neonatal Encephalopathy
The Impact of Holding on Stress and Bonding in Mother-Infant Pairs During Therapeutic Hypothermia
This research is being done to try to improve the experience of mothers and babies during therapeutic hypothermia. Currently, mothers are not able to hold their baby during hypothermia treatment.
- Trial name
- NCT03837717
- Testing
- Holding, Saliva collection, No Holding
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- MaineHealth
Hypoxic-ischemic Encephalopathy, Neonatal Encephalopathy
Neonatal Erythropoietin And Therapeutic Hypothermia Outcomes in Newborn Brain Injury (NEATO)
Hypoxic-ischemic encephalopathy (HIE), a condition of reduced blood and oxygen flow to a baby's brain near the time of birth, may cause death or neurologic disability.
- Conditions
- Hypoxic-ischemic Encephalopathy, Neonatal Encephalopathy, Birth Asphyxia
- Trial name
- NEATO (NCT01913340)
- Testing
- Erythropoietin, Normal saline
- Where
- 7 sites in United States
- Volunteers
- 50 people
- Sponsor
- University of California, San Francisco
Out-Of-Hospital Cardiac Arrest, Myocardial Infarction, Acute
Benefit of Hypothermia in OHCA Complicating AMI
To determine the clinical effectiveness of hypothermia treatment in patients with out-of-hospital cardiac arrest complicating acute myocardial infarction.
- Conditions
- Out-Of-Hospital Cardiac Arrest, Myocardial Infarction, Acute, Hypothermia Neonatal
- Trial name
- Hypothermia (NCT06141252)
- Testing
- Hypothermia
- Where
- South Korea
- Volunteers
- 2,925 people
- Sponsor
- Yonsei University
Hypothermia Neonatal
Electricity-free Infant Warmer for Newborn Thermoregulation in Rwanda
Hypothermia contributes to a significant portion of neonatal deaths. Kangaroo mother care (KMC) is a safe and effective method of warming; however, it is not always feasible, and not possible in settings such as resuscitation or…
- Trial name
- NCT03031431
- Testing
- Non-Electric Infant Warmer
- Where
- Rwanda
- Volunteers
- 130 people
- Sponsor
- Boston Children's Hospital
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
Neonatal Hypothermia
Pilot Clinical Assessment of Low-cost Infant Incubator in Monitoring Temperature and Treating Hypothermia in Infants
A team of researchers at Rice University and Queen Elizabeth Central Hospital (QECH) are working to develop a low-cost infant incubator called "IncuBaby" that consists of two components: a temperature sensor that can continuously…
- Trial name
- NCT03965312
- Testing
- Continuous temperature monitor, Neonatal Incubator, Patient monitor
- Where
- Malawi
- Volunteers
- 150 people
- Sponsor
- William Marsh Rice University
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
Hypoxic-ischemic Encephalopathy (HIE)
Therapeutic Hypothermia for Neonatal Hypoxic-Ischemic Encephalopathy in Vietnam
This study aims to evaluate the effectiveness of therapeutic hypothermia in neonates diagnosed with hypoxic-ischemic encephalopathy (HIE).
- Trial name
- HIE-TH Vietnam (NCT07555652)
- Testing
- Therapeutic Hypothermia
- Where
- Vietnam
- Volunteers
- 120 people
- Sponsor
- National Children's Hospital, Vietnam
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
Neonatal Hypothermia
Active Warming Versus Non Active Warming During Caesarean Section for Preventing Neonatal Hypothermia
Peri-operative warming is well established for general operations, but there is limited literature on the active warming of pregnant women undergoing caesarean section (CS).
- Trial name
- NeoHyp (NCT03316716)
- Testing
- active warming
- Where
- Ireland
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Aliona Vilinsky-Redmond
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
Hypothermia, Newborn
Kangaroo Mother Care to Prevent Hypothermia in Preterm Infants
The overall hypothesis is that better adherence to Kangaroo Mother Care (KMC) in combination with existing WHO thermoregulation care will reduce the incidence of moderate hypothermia (32-36 degrees C) or severe hypothermia (<32.0…
- Trial name
- NCT02189746
- Testing
- Continuous Kangaroo Mother Care to 1 hour after birth, Standard Kangaroo Mother Care to 1 hour after birth, Continuous Kangaroo Mother Care to discharge
- Where
- Zambia
- Volunteers
- 140 people
- Sponsor
- University of Alabama at Birmingham
Preterm Neonates
Polyethylene Bag: a Way of Preventing Hypothermia During Central Venous Catheter Placement in Preterm Neonates?
Particular attention is paid to thermal management of preterm neonates in neonatal intensive care units because of the major risk of morbidity associated with hypothermia.
- Trial name
- PSac (NCT02798926)
- Testing
- polyethylene bag
- Where
- France
- Volunteers
- 63 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens