Clinical trials: Hypothermia, Preterm Infants
Preterm Birth, Hypothermia, Newborn
Kangaroo Mother Care With Plastic Bag (Trials 1A & 1B)
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
- NCT03141736
- Testing
- KMC & WHO protocol (0-1 hour), KMC, WHO protocol & bag (0-1 hour), KMC & WHO protocol (1-24 hours)
- Sponsor
- University of Alabama at Birmingham
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
Hypothermia
mOm Incubator Pilot Study
The mOm Incubator is a collapsible infant incubator designed to provide a level of thermoregulation that meets the standards set for conventional incubators whilst being low cost and space-saving.
- Trial name
- NCT03450668
- Testing
- mOm incubator, standard incubator
- Where
- United Kingdom
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- mOm incubators
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
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
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
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
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
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
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
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, 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
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
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, 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
Hypothermia, Newborn
Efficacy of A Novel in Prevention of Neonatal Hypothermia
The research was carried out to determine the effect of baby warmer swaddle, which has a heating system used after the birth of preterm babies, on the development of hypothermia.
- Conditions
- Hypothermia, Newborn, Preterm Birth
- Trial name
- NCT05729698
- Testing
- Baby warmer swaddle, polyethylene bag
- Where
- Turkey (Türkiye)
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- Istanbul University - Cerrahpasa
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
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
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