Clinical trials: Neonatal Hypothermia
Hypoxic Encephalopathy, Birth Asphyxia
Passive Cooling Versus Blanket-Roll III on The Myocardial Function of Asphyxiated Neonates
Studying the effect of passive versus Blanket roll III modality of therapeutic hypothermia (TH)on myocardial function of asphyxiated neonates through using tissue Doppler (TD).
- Conditions
- Hypoxic Encephalopathy, Birth Asphyxia, Neonatal Encephalopathy, Hypothermia, Newborn
- Trial name
- NCT05652738
- Testing
- Passive cooling application, cooling using Blanket roll III
- Where
- Egypt
- Volunteers
- 100 people
- Sponsor
- Alexandria University
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
Encephalopathy, Hypoxic Ischemic
Neurodevelopmental Outcome in Newborn With Hypoxic-ischemic Encephalopathy Treated With Therapeutic Hypothermia
The goal of this observational study is to identify early signs of poor neurodevelopmental outcome by performing specific neurological, neurophysiological and neuroimaging assessments in newborns with hypoxic-ischemic…
- Trial name
- NCT05767476
- Testing
- Clinical and instrumental neurological assessment
- Where
- 2 sites in Italy
- Volunteers
- 70 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Hypoxic Ischaemic Encephalopathy
Xenon and Cooling Therapy in Babies at High Risk of Brain Injury Following Poor Condition at Birth
This study examines the effect of inhaled xenon gas in the treatment of newborn infants with hypoxic-ischemic encephalopathy (HIE) in combination with cooling, which is the standard treatment for this condition.
- Trial name
- CoolXenon2 (NCT01545271)
- Testing
- xenon gas, Whole body cooling
- Where
- United Kingdom
- Volunteers
- 32 people
- Sponsor
- University Hospitals Bristol and Weston NHS Foundation Trust
Newborn; Vitality, Iron Deficiency Anemia
The Importance of Delayed Cord Clamping
After birth, the umbilical cord is usually clamped and separated from the placenta within the first 30 seconds. Although the exact time to clamp the umbilical cord is unknown, allowing placental transfusion after birth has many…
- Trial name
- NCT06405867
- Testing
- delayed cord clamping (> 60 sec)
- Where
- Turkey (Türkiye)
- Volunteers
- 316 people, healthy volunteers welcome
- Sponsor
- Goztepe Prof Dr Suleyman Yalcın City Hospital
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
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
Effect of Reflexology, Hypoxic-Ischemic Encephalopathy, Neonatal
Foot Reflexology in Neonates With Hypoxic-Ischemic Encephalopathy
This randomized controlled trial aims to evaluate the effect of foot reflexology on comfort levels and physiological parameters in neonates with hypoxic-ischemic encephalopathy undergoing therapeutic hypothermia.
- Conditions
- Effect of Reflexology, Hypoxic-Ischemic Encephalopathy, Neonatal, Foot Reflexology, Therapeutic Hypothermia
- Trial name
- NCT07549789
- Testing
- Foot reflexology, Standard care
- Where
- Turkey (Türkiye)
- Volunteers
- 84 people
- Sponsor
- Istanbul Nisantasi University
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
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, 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
Preterm Infant, Low Birth Weight Infant
m-Health System for Tracking Kangaroo Mother Care and Temperature in Southern India
The product innovation is a wearable device that (combined with a smartphone and back-end analytics system) acts as a sensor, processor and actuator, and is therefore designed to identify critical parameters (Kangaroo Mother Care…
- Conditions
- Preterm Infant, Low Birth Weight Infant, Kangaroo Mother Care, Hypothermia, Newborn
- Trial name
- NCT04929977
- Testing
- Wearable device with smart mobile phone
- Where
- India
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- St. John's Research Institute
Hypoxic-ischemic Encephalopathy (HIE)
The PROTECT-HIE Pilot Trial
Some babies experience a lack of oxygen and blood flow around the time of birth. This can lead to a serious condition called hypoxic-ischemic encephalopathy (HIE), which can injure the brain and other organs, including the heart.
- Trial name
- PROTECT-HIE (NCT07406477)
- Testing
- Dobutamine, TnECHO
- Where
- 2 sites in Canada
- Volunteers
- 40 people
- Sponsor
- University of Alberta
Necrotizing Enterocolitis
Therapeutic Controlled Hypothermia in the Treatment of Neonates With Severe Necrotizing Enterocolitis
Hypothesis: Controlled hypothermia to 33.5C for 48 hours reduces the severity of critical illness in neonates with severe necrotizing enterocolitis.
- Trial name
- CoolNEC (NCT01330576)
- Testing
- cooling blanket/mattress, Standard treatment of care at normothermia
- Where
- United Kingdom
- Volunteers
- 13 people
- Sponsor
- Great Ormond Street Hospital for Children NHS Foundation Trust
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
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
HIE - Perinatal Hypoxic - Ischemic Encephalopathy
NVD in Hypothermic HIE Neonates
Neonatal hypoxic ischemic (HI) injury is an unpredictable neurologic injury with devastating, long term consequences for parents who are expecting a normal child.
- Trial name
- NCT04643821
- Testing
- N-acetylcysteine, NAC, and calcitriol
- Volunteers
- 30 people
- Sponsor
- Medical University of South Carolina
Hypoxic Ischemic Encephalopathy of Newborn, Feeding Patterns
Continuous Versus Bolus Feeding in Neonates With Hypoxic Ischemic Encephalopathy
Therapeutic hypothermia (TH) is accepted worldwide as a standard of care for infants born at or beyond 36 weeks gestational age with moderate-to-severe hypoxic ischaemic encephalopathy (HIE).
- Trial name
- NCT06447155
- Testing
- Bolus feeding, Continuous feeding
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people
- Sponsor
- Istanbul Training and Research Hospital
Hypoxic Ischemic Encephalopathy
Topiramate in Neonates Receiving Whole Body Cooling for Hypoxic Ischemic Encephalopathy
The goal is to see whether topiramate (an anti-epileptic agent) improves the outcome of babies with neonatal hypoxic encephalopathy who are receiving whole body cooling.
- Trial name
- NCT01765218
- Testing
- Topiramate
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Kristin R Hoffman
Hypothermia, Newborn
Kangaroo Mother Care to Prevent Hypothermia in Term 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
- NCT02189759
- Testing
- Continuous Kangaroo Mother Care to one hour after birth, Standard Kangaroo Mother Care to one hour after birth, Continuous Kangaroo Mother Care to discharge
- Where
- Zambia
- Volunteers
- 375 people
- Sponsor
- University of Alabama at Birmingham