Clinical trials: Neonatal Hypothermia
Hypothermia; Anesthesia
Evaluation of the Active Warming Effects on Maternal and Neonatal Outcome During Cesarean Delivery
A prospective randomized study of healthy term parturients undergoing cesarean delivery was designed to assess the impact of the active warming on perioperative and postoperative temperature.
- Trial name
- NCT03473470
- Testing
- forced air warming and warmed intravenous fluids, warmed intravenous fluids
- Where
- Italy
- Volunteers
- 165 people, healthy volunteers welcome
- Sponsor
- University of Foggia
Preterm Less Than 32wks With IVH, WMI/PVL, Late Preterm or Term (37-42wks) With Neonatal Encephalopathy Treated With Hypothermia for HIE
Cerebral/ Cortical Visual Impairment: Screening, Identification and Outcome Prediction in Neonates
Cerebral/Cortical Visual Impairment (CVI) is the leading cause of childhood visual impairment in the United States and other industrialized countries.
- Trial name
- CVI (NCT07275021)
- Testing
- Prospective Clinical and Neurodevelopmental Data Collection
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Brigham and Women's Hospital
Hypoxic-Ischemic Encephalopathy, Pain
Dexmedetomidine Use in Infants Undergoing Cooling Due to Neonatal Encephalopathy (DICE Trial)
Management of neonatal pain and sedation often includes opioid therapy. A growing body of evidence suggests long-term harm associated with neonatal opioid exposure.
- Trial name
- DICE (NCT04772222)
- Testing
- Dexmedetomidine Hydrochloride, Morphine Sulfate
- Where
- 5 sites in United States
- Volunteers
- 50 people
- Sponsor
- University of Utah
Hypothermia; Anesthesia, Hypothermia, Newborn
Perioperative Warming Measures in Cesarean Delivery
The purpose of this study is to evaluate the best method for keeping patients warm during cesarean deliveries and the effect of temperature change on the patient and baby
- Conditions
- Hypothermia; Anesthesia, Hypothermia, Newborn, Hypothermia, Sequela
- Trial name
- NCT05015582
- Testing
- Pre op upper body forced air warming (32˚C), Pre op lower body forced air warming (32˚C), Pre op fluids (45˚C)
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- The University of Texas Health Science Center, Houston
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
Hypothermia
Plastic Hat Trial to Prevent Hypothermia in Preterm Newborns in the Delivery Room
The purpose of this research project is to ascertain the effectiveness of plastic head covering in prevention of hypothermia. Hypothermia is defined by body temperature <36.5º Celsius by the World Health Organization.
- Trial name
- NCT00904228
- Testing
- placement of plastic cap during delivery room stabilization, placement of routine cap during delivery room stabilization
- Where
- United States
- Volunteers
- 260 people, healthy volunteers welcome
- Sponsor
- University of Texas Southwestern Medical Center
Hypoxic Ischemic Encephalopathy
Whole Body Cooling Using Phase Changing Material
A prospective randomized control trial to examine safety and effectiveness of whole body cooling to a rectal temperature of 33.5 C using phase changing material in neonatal encephalopathy.
- Trial name
- NCT01138176
- Testing
- Cooling
- Where
- India
- Volunteers
- 35 people
- Sponsor
- Robertson, Nicola, M.D.
Hypoxic-Ischemic Encephalopathy, Asphyxia
Hydrocortisone Therapy Optimization During Hypothermia Treatment in Asphyxiated Neonates
This is a prospective, single center, pharmacokinetic study of intravenous hydrocortisone therapy for systemic low blood pressure during hypothermia treatment in asphyxiated newborns.
- Conditions
- Hypoxic-Ischemic Encephalopathy, Asphyxia, Hypotension, Circulatory Failure Neonatal
- Trial name
- UniCort (NCT05836610)
- Testing
- Hydrocortisone
- Where
- Hungary
- Volunteers
- 50 people
- Sponsor
- Semmelweis University
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, 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
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
Hypothermia
Evaluation of Use of Plastic Bags to Prevent Neonatal Hypothermia-Part III
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
- NCT01604434
- Testing
- Incubator-torso bag, Incubator-no plastic bag
- Where
- Zambia
- Sponsor
- University of Alabama at Birmingham
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
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
Acute Kidney Injury, HIE
Theophylline Prophylaxis During Hypothermia to Limit Neonatal Nephron Damage
Acute kidney injury is a significant complication for infants who experience hypoxic ischemic encephalopathy, being associated with increased rates of death and prolonged hospitalization.
- Trial name
- TheoPHyLNNe (NCT05853601)
- Testing
- Single Dose Theophylline, Repeat Dose Theophylline
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Medical College of Wisconsin
Hypoxic Ischemic Encephalopathy (HIE)
Severity of Hypoxic Ischemic Encephalopathy and Neurological Pupil Index in Neonates
The goal of this observational study is to learn if the reactivity of a newborn's eye to light (measured as an index, using a new device -pupillometer) reflect the health of their brain recovering from disruption of blood/oxygen…
- Trial name
- SHINE (NCT07024771)
- Testing
- Automated Pupillometer
- Where
- Canada
- Volunteers
- 25 people
- Sponsor
- University of Calgary
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
Hypoxic Ischemic Encephalopathy
Safety and Efficacy of Topiramate in Neonates With Hypoxic Ischemic Encephalopathy Treated With Hypothermia
The purpose of this study is to determine whether the administration of topiramate to newborns with hypoxic-ischemic encephalopathy potentiates the neuroprotective effect of treatment with hypothermia.
- Trial name
- NeoNATI (NCT01241019)
- Testing
- Topiramate in newborns with hypoxic ischemic encephalopathy treated with therapeutic hypothermia
- Where
- 2 sites in Italy
- Volunteers
- 64 people
- Sponsor
- Meyer Children's Hospital IRCCS
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
Neonatal Encephalopathy
Hypothermia for Encephalopathy in Low and Middle-Income Countries Trial
Neonatal Encephalopathy is a serious condition arising from unexpected lack of cerebral blood flow and oxygen supply to the foetal brain at the time of birth.
- Trial name
- HELIX (NCT02387385)
- Testing
- Whole body cooling (Tecotherm)
- Where
- 9 sites in Bangladesh, India and 1 more
- Volunteers
- 408 people
- Sponsor
- Thayyil, Sudhin