Clinical trials: Hypothermia Neonatal
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
Newborn Hypoxic-Ischemic Encephalopathy
Evaluation of a PCM Mattress to Treat HIE Infants During Transport
Background the research proposed herein is in line with the Swedish Research Council's current focus on International collaborations and postdoctoral work abroad.
- Trial name
- PCMhypo (NCT05361473)
- Testing
- The NeoHilda Point of care method, Traditional evaluation
- Where
- Vietnam
- Volunteers
- 140 people
- Sponsor
- Karolinska Institutet
Hypoxic-Ischemic Encephalopathy
Systemic Hypothermia Improves Outcome of Hypoxic-Ischemic Encephalopathy
Perinatal asphyxia-induced brain injury is one of the most common causes of morbidity and mortality in term and preterm neonates.
- Trial name
- NCT00817401
- Testing
- hypothermia
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Zhengzhou University
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
Infant, Premature
Cardboard Cot: Prevention of Moderate or Severe Hypothermia in Preterm Infants Assigned to Open Crib
Infants with an estimated gestational age < 36 6/7 weeks at delivery who have been in an incubator in the newborn ICU for at least 24 hours in settings where an incubator is available, or who are delivered in a setting where an…
- Trial name
- NCT03344991
- Testing
- Cardboard Cot Care, Open Crib
- Sponsor
- University of Alabama at Birmingham
Hypothermia
Evaluation of Use of Plastic Bags to Prevent Neonatal Hypothermia-Part II
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
- NCT01604421
- Testing
- Thermoregulation-standard care, Thermoregulation with plastic bag
- Where
- Zambia
- Sponsor
- University of Alabama at Birmingham
Hypothermia, Newborn
Influence of Duration Since Birth Until Admission to Well-baby Nursery on Neonatal Temperature at Admission
The investigators will collect the time interval from birth to arrival to WBN or NICU, the time interval from arrival to nurse admission, the first measured temperature, and the week of birth.
- Trial name
- NCT05505903
- Testing
- Temerature measurement
- Where
- Israel
- Volunteers
- 2,412 people, healthy volunteers welcome
- Sponsor
- Hillel Yaffe Medical Center
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 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.
Asphyxia Neonatorum, Morbidity;Newborn
Effects of Probiotic Mixture Supplementation and Evaluation of Intestinal Mucosal Tolerance and Gut Microbiome in Newborns With Perinatal Asphyxia Receiving Hypothermic Treatment
The VISNAT trial is a PILOT STUDY due to absence of previous evidences in literature on using probiotic in newborns with perinatal asphyxia.
- Trial name
- VISNAT (NCT04145713)
- Testing
- Probiotic mixture
- Where
- Italy
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Policlinico Hospital
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
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
Hypothermia, Newborn, Body Temperature Changes
Early Weaning From Incubator To Crib
The purpose of this study is to determine the safety and feasibility of weaning from the incubator at a lower post-natal weight at 1600 grams.
- Conditions
- Hypothermia, Newborn, Body Temperature Changes, Newborn Thermal Injury
- Trial name
- NCT06230172
- Testing
- Weaning incubator (heat) at an lower postnatal weight
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Augusta University
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
Hypoxic-Ischemic Encephalopathy
Sildenafil Plus Hypothermia to Treat Neonatal Encephalopathy
The main objective of this study is to assess pharmacokinetics features of IV sildenafil in neonates with hypoxic-ischemic encephalopathy and treated by controlled hypothermia.
- Trial name
- SHINE1 (NCT06810284)
- Testing
- Sildenafil Citrate (IV)
- Where
- France
- Volunteers
- 24 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Neonatal Encephalopathy
Enteral Feeding and Splanchnic NIRS Values in Infants With Neonatal Encephalopathy (NE)
The research team plans to administer trophic enteral feeds to infants with Neonatal Encephalopathy that are undergoing therapeutic hypothermia.
- Trial name
- NCT05471336
- Testing
- Enteral Feeding
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- NYU Langone Health
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
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
Hypothermia, Neonatal Outcome
Hypothermia and the Effect of Ambient Temperature 2
Neonatal hypothermia is associated with increased risk of mortality as well as multiple morbidities. The prior HEAT study conducted at our institution showed a difference in neonatal hypothermia with a change in ambient operating…
- Conditions
- Hypothermia, Neonatal Outcome, Cesarean Section
- Trial name
- HEAT2 (NCT03008577)
- Testing
- Change in ambient operating room temperature
- Where
- United States
- Volunteers
- 5,221 people, healthy volunteers welcome
- Sponsor
- University of Texas Southwestern Medical Center