Clinical trials: Hypothermia, Preterm Infants
Neonatal Hypothermia, Brown Adipose Tissue
Investigation of the Mechanisms of the Tendency to Hypothermia in Newborns and Premature Neonates
Newborns have thermoregulatory mechanisms that differ from those of adults. Instead of producing heat through shivering, newborns primarily rely on non-shivering thermogenesis by the brown adipose tissue.
- Conditions
- Neonatal Hypothermia, Brown Adipose Tissue, Preterm and Term Infants, Neonate
- Trial name
- NCT06803069
- Where
- 2 sites in Hungary
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University of Pecs
Infant, Newborn, Hypoxia, Brain
Preemie Hypothermia for Neonatal Encephalopathy
This study is a randomized, controlled trial to assess safety and effectiveness of whole body hypothermia for 72 hours in preterm infants 33-35 weeks gestational age (GA) who present at <6 hours postnatal age with moderate to…
- Conditions
- Infant, Newborn, Hypoxia, Brain, Hypoxia-Ischemia, Brain, Encephalopathy, Hypoxic-Ischemic
- Trial name
- NCT01793129
- Testing
- Hypothermia, Normothermic Control
- Where
- 18 sites in United States
- Volunteers
- 168 people
- Sponsor
- NICHD Neonatal Research Network
Hypoxic Ischemic Encephalopathy
Pilot Study of Head Cooling in Preterm Infants With Hypoxic Ischemic Encephalopathy
The hypothesis is that premature infants' can have enough cooling applied to cool their brain to decrease CNS injury without cooling their body.
- Trial name
- NCT00620711
- Testing
- Olympic Cool Cap
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Vanderbilt University
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
Neonatal Encephalopathy
Transcutaneous Carbon Dioxide Monitoring in Neonates Receiving Therapeutic Hypothermia for Neonatal Encephalopathy
The aim of our study is to evaluate the feasibility of applying transcutaneous CO2 monitoring (tcPCO2) in neonates receiving therapeutic hypothermia and to quantify the agreement between tcPCO2 and PCO2 in this population with or…
- Trial name
- NCT04603547
- Testing
- Transcutaneous Carbon Dioxide Monitoring
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- Brigham and Women's Hospital
Hypothermia, Preterm Infant
Heat Loss Prevention in Very Preterm Infants in Delivery Rooms: A Multicenter, Randomized, Controlled Trial of Polyethylene Occlusive Total Body Skin Wrapping
Hypothermia after delivery is a world-wide problem associated with morbidity and mortality. The conventional approach of drying the baby with a pre-warmed towel and radiant warmers is unsuccessful in a large proportion of very…
- Trial name
- NCT01671241
- Testing
- Polyethylene wrap
- Where
- Italy
- Volunteers
- 80 people
- Sponsor
- University of Padova
Transfusion Related Complication, Premature
Warmed Blood Transfusion in Premature Infants
Premature babies have to deal with many problems from the moment they are born due to the immature of their organs. Their clinical condition is unstable, especially in the first few weeks, and they are greatly affected by…
- Trial name
- NCT06425783
- Testing
- Warmed Blood Transfusion
- Where
- Turkey (Türkiye)
- Volunteers
- 50 people
- Sponsor
- Goztepe Prof Dr Suleyman Yalcın City Hospital
Respiratory Distress, Hypoglycemia
Observational Study of Infants Born at 34 to 37 Weeks of Gestation Until the Age of 1 Year
Late preterm infants are at an increased risk for short and long term morbidity (during the 1st year of life, their neurodevelopmental status may also be delayed as compared to infants born at term).
- Conditions
- Respiratory Distress, Hypoglycemia, Feeding Intolerance, Jaundice
- Trial name
- NCT00550069
- Where
- Israel
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Sheba Medical Center
Neonatal Hypothermia
Hypothermia Prevention in Low Birthweight and Preterm Infants
Preterm birth complications are the leading cause of neonatal mortality and account for over one million neonatal deaths annually.
- Trial name
- NCT04364204
- Testing
- Kangaroo Mother Care and BEMPU bracelet, Kangaroo Mother Care
- Where
- 6 sites in Ghana
- Volunteers
- 380 people
- Sponsor
- University of South Carolina
Hypothermia
Clinical Performance of the Embrace Isothermal Mattress
The purpose of this pilot study is to evaluate the performance of a new warming technology (Embrace Isothermal Mattress) during the thermal weaning of premature infants from incubators to open cribs.
- Trial name
- KBW (NCT01425086)
- Testing
- Embrace, PCM, warming blanket
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Stanford University
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, Anemia
Delayed Cord Clamping in Premature Infants
Delayed cord clamping has been shown to decrease the risk of bleeding in the brain of premature infants. However this procedure is not standard due to concerns that the premature infant will get too cold.
- Trial name
- NCT01018576
- Testing
- Delayed cord clamping
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- University of California, Davis
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
Hypothermia, Preterm Infants
Heat Loss Prevention in Delivery Room Using a Polyethylene Cap
It is apparent that the head of a preterm infant should not be left uncovered, however it remains unclear whether covering the head of a preterm baby with plastic wrapping is effective in preventing heat loss.
- Trial name
- NCT00930917
- Testing
- Polyethylene cap, Polyethylene wrap, conventional treatment
- Volunteers
- 96 people
- Sponsor
- University of Padova
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
Preterm Birth, Blood Transfusion Complication
Blood Warming in Preterm Infants to Decrease Hypothermia
Background/significance: Over 100,000 early preterm infants are born annually in the United States and suffer morbidity and mortality during hospitalization in a neonatal intensive care unit. One such condition is hypothermia.
- Conditions
- Preterm Birth, Blood Transfusion Complication, Hypothermia
- Trial name
- NCT05170633
- Testing
- Ranger blood warmer (3M Healthcare, Oakdale, Minnesota)
- Where
- United States
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- University of South Carolina
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
Preterm Infants
Weaning Preterm Infants at 1500 Grams From Incubators
Background: The weight at which infants are weaned from incubators varies among neonatal units. Objective: To determine the effect on weight gain, temperature stability and resting energy expenditure (REE) of weaning infants at…
- Trial name
- NCT01083303
- Testing
- Weaning Preterm Infants from an incubator
- Where
- Israel
- Volunteers
- 21 people
- Sponsor
- Tel-Aviv Sourasky Medical Center
Preterm Infant, Hypothermia, Newborn
Early Kangaroo Mother Care in Gambian Hospitalised Unstable Neonates
The mortality effect of kangaroo mother care in stable newborns <2000g is well established but mortality effect in unstable newborns is not conclusively known.
- Conditions
- Preterm Infant, Hypothermia, Newborn, Death, Kangaroo Mother Care
- Trial name
- eKMC (NCT03555981)
- Testing
- Early Kangaroo Mother Care, Standard care
- Where
- The Gambia
- Volunteers
- 279 people
- Sponsor
- London School of Hygiene and Tropical Medicine
Prematurity, Neonatal Encephalopathy
Evaluating the NeoTree in Malawi and Zimbabwe
Neonatal mortality remains unacceptably high. Globally, the majority of mothers now deliver in health facilities in low resource settings where quality of newborn care is poor.
- Conditions
- Prematurity, Neonatal Encephalopathy, Neonatal Sepsis, Neonatal Death
- Trial name
- NCT05127070
- Testing
- Neotree
- Where
- 5 sites in Malawi, Zimbabwe
- Volunteers
- 19,000 people
- Sponsor
- University College, London