Clinical trials: Hypothermia Neonatal
Congenital Heart Defects, Hypoplastic Left Heart Syndrome
Cerebral Perfusion During Neonatal Cardiac Surgery
Neonates with a congenital heart defect are often in need of early cardiac surgery. In complex congenital heart defects, cardiopulmonary bypass is usually employed, with or without deep hypothermic circulatory arrest (DHCA).
- Conditions
- Congenital Heart Defects, Hypoplastic Left Heart Syndrome, Aortic Coarctation
- Trial name
- NCT01032876
- Testing
- Deep Hypothermic Circulatory Arrest, Antegrade Cerebral Perfusion
- Where
- Netherlands
- Volunteers
- 37 people
- Sponsor
- UMC Utrecht
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, Newborn
Evaluate the Use of Plastic Bags in Preventing and Treating Hypothermia in Neonates
The overall hypothesis is that placing infants 1000-2500 grams in plastic bags when compared to routine care will reduce the risk of hypothermia (< 36.5 degrees C) without increasing hyperthermia (> 37.5 degrees C).
- Trial name
- NCT01403623
- Testing
- Resuscitation and post resuscitation care with plastic bag, Resuscitation- no plastic bag for temperature regulation
- Where
- Zambia
- Volunteers
- 106 people
- Sponsor
- University of Alabama at Birmingham
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
Preterm Infant, Hypothermia Neonatal
Kangaroo Mother Care With Plastic Bag (Trials 2A & 2B)
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
- NCT03141723
- Testing
- KMC & WHO protocol (0-1 hour), KMC, WHO protocol & bag (0-1 hour), KMC & WHO protocol (1-24 hours)
- Where
- Zambia
- Volunteers
- 423 people
- Sponsor
- University of Alabama at Birmingham
Hypoxic Ischemic Brain Injury, Neonatal Encephalopathy
Dexmedetomidine Versus Morphine During Cooling Therapy in Neonates
About ~3/ 1000 live-born newborns may suffer from brain injury due to a transient drop in oxygen supply to the brain during the birth process.
- Conditions
- Hypoxic Ischemic Brain Injury, Neonatal Encephalopathy, Perinatal Anoxic-ischemic Brain Injury
- Trial name
- COOL-SED (NCT06985290)
- Testing
- Dexmedetomidine Infusion, Morphine Infusion
- Where
- Canada
- Volunteers
- 50 people
- Sponsor
- Ipsita Goswami
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, 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, Immature Newborn
Evaluation of Use of Plastic Bags to Prevent Neonatal Hypothermia-Part I
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
- NCT01604317
- Testing
- Resuscitation-torso plastic bag, Resuscitation-partial-head plastic bag
- Where
- Zambia
- Volunteers
- 182 people
- Sponsor
- University of Alabama at Birmingham
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
Neonatal Encephalopathy
Telemedicine to Improve Use of Therapeutic Hypothermia in Rural Settings
This pilot intervention trial will assess the feasibility of a live consultation between community hospital providers and tertiary care providers employing a novel teleconsult platform, Maine Neonatal Encephalopathy Teleconsult…
- Trial name
- NCT03706417
- Testing
- Telemedicine consult
- Where
- United States
- Volunteers
- 115 people
- Sponsor
- MaineHealth
Music Therapy, Pain
Music Therapy During Hypothermia in the NICU
Background: Hypoxic-ischemic encephalopathy (HIE) is a neurological condition caused by poor oxygenation during the peripartum period.
- Conditions
- Music Therapy, Pain, Allodynia, Neonates
- Trial name
- NCT06951269
- Testing
- Live entrained music therapy
- Where
- Colombia
- Volunteers
- 22 people
- Sponsor
- Fundación Santa Fe de Bogota
Cardiac, Aortic Arch Surgery
Brain Vascular Reactivity to Hypothermic Circulatory Arrest With Antegrade Cerebral Perfusion During Aortic Arch Surgery
Many neonates and infants who undergo complex cardiac surgery are affected by neurological developmental delays. Whilst catastrophic events are immediately identifiable from clinical examination or by macro changes on MRI or CT…
- Conditions
- Cardiac, Aortic Arch Surgery, Brain Vascular, Neonates
- Trial name
- NCT03047876
- Testing
- aortic arch surgery
- Where
- United Kingdom
- Volunteers
- 20 people
- Sponsor
- Alder Hey Children's NHS Foundation Trust
Newborn Asphyxia
Is Feeding During Therapeutic Hypothermia Safe and Can Improve Outcomes in Infants With Hypoxic-ischaemic Encephalopathy
Therapeutic hypothermia (TH) is the standard of care for newborns with moderate to severe hypoxic-ischaemic encephalopathy (HIE) born at 35 weeks or more of gestation.
- Trial name
- NCT06394453
- Testing
- enteral feeding with mother milk or human donor breast milk
- Where
- Poland
- Volunteers
- 104 people
- Sponsor
- Nutricia Foundation
Hyperthermia, Hypothermia
Testing A Visual Thermometer in Newborns and Young Infants
"Severe neonatal jaundice and acute bilirubin encephalopathy are a major cause of death and disability among newborns in LMICs. Filtered sunlight phototherapy (FSPT) was developed, tested and shown to be safe and efficacious in…
- Trial name
- NCT05609292
- Testing
- observational
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- University of Minnesota
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
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
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
Newborn, Infant
Placing Preterm Infants in Polyethylene Bags Immediately After Birth
Primary objective: To determine if placing preterm infants in a polyethylene bag (PB) immediately after birth, before the umbilical cord is clamped, will increase the number of preterm infants with a normal temperature on…
- Conditions
- Newborn, Infant, Hypothermia, Premature
- Trial name
- NCT04463511
- Testing
- Polyethylene bag before the umbilical cord is clamped
- Where
- Ireland
- Volunteers
- 194 people, healthy volunteers welcome
- Sponsor
- University College Dublin
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