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Hypothermia Neonatal clinical trials

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NCT ID: NCT06277843 Completed - Preterm Clinical Trials

Low-Cost and Reusable Thermal Jacket for Managing Preterm or Low Birth Weight Neonates.

Start date: June 13, 2022
Phase: Early Phase 1
Study type: Interventional

Globally, over 15 million neonates are born preterm each year. They account for approximately 30% of global neonatal deaths and 19% of total neonatal deaths in Bangladesh. They usually die because they cannot maintain normal temperature due to their weight, immature skin and underdeveloped thermal regulatory capacity of the brain. Maintaining continuous KMC for at least 16-20 hours/day, is sometimes not feasible for mothers or caregivers. In addition, we also have the challenge of keeping preterm or LBW neonates warm during transportation. The scientists at icddr,b, Johns Hopkins University, and George Mason University developed the re-usable thermal jacket for keeping preterm or low-birth-weight neonate warm. We propose to build on previous work by systematically testing the safety of the 'thermal jacket' among preterm or low birthweight (LBW) neonates. Objective of this study is to conduct clinical safety trial of the thermal jacket to test whether the thermal jacket can retain euthermia of preterm or LBW neonates for 2 hours.

NCT ID: NCT06141252 Active, not recruiting - Clinical trials for Out-Of-Hospital Cardiac Arrest

Benefit of Hypothermia in OHCA Complicating AMI

Hypothermia
Start date: November 15, 2023
Phase: N/A
Study type: Interventional

To determine the clinical effectiveness of hypothermia treatment in patients with out-of-hospital cardiac arrest complicating acute myocardial infarction.

NCT ID: NCT05574855 Recruiting - Perinatal Asphyxia Clinical Trials

Evaluation of Haemodynamic in Neonates Treated With Hypothermia"

Start date: August 1, 2021
Phase:
Study type: Observational [Patient Registry]

Perinatal hypoxia in the form of hypoxic-ischaemic encephalopathy (HIE) is a frequent cause of cerebral impairment in neonates. HIE occurs in 3 to 5 of 1000 neonates in developed countries and is significantly higher in developing countries at 25 of 1000 neonates. Despite developments in medicine, increasing understanding of HIE pathophysiology and progress in neonatal intensive care as well as treatment of moderate or severe perinatal asphyxia, HIE continues to be associated with significant mortality and late neurological sequelae. Episodes of ischaemia-hypoxia in the perinatal period as well as the changes in the redistribution of blood may lead to decreased perfusion and ischaemia of the cardiac muscle. Additionally, there is a negative impact from the reduced contractility of the cardiac muscle secondary to acidosis and hypoxia. Therapeutic hypothermia (TH) improves the late effects in moderate and severe cases of hypoxia-ischaemia encephalopathy (HIE). The direct impact of TH on the cardiovascular system includes moderate bradycardia, increased pulmonary vascular resistance (PVR), inferior filling of the left ventricle (LV) and LV stroke volume. The above-mentioned consequences of TH and episodes of HI in the perinatal period are therefore exacerbation of respiratory and circulatory failure. The impact of the warming phase on the cardiovascular system is not well researched and currently few data has been published on this topic. Physiologically, warming increases heart rate, improves cardiac output and increases systemic pressure. The effect of TH and the warming phase on the cardiovascular values has a decisive impact on the metabolism of drugs, including vasopressors / inotropics, which in turn affects the choice of medication and fluid therapy

NCT ID: NCT03890211 Active, not recruiting - Clinical trials for Hypothermia Neonatal

Trial of a Non Electric Infant Warmer for Prevention and Treatment of Hypothermia in Rwanda

Start date: November 11, 2019
Phase: N/A
Study type: Interventional

Hypothermia contributes to a significant portion of neonatal deaths. Kangaroo Mother Care (KMC) is a safe and effective method of warming; however, it is not always feasible, for example in settings such as resuscitation or clinical instability. Electric warmers are the standard of care in developed countries, but are extremely costly, complicated with risk of causing both hypo and hyperthermia with misuse, and often not reliable in settings without stable electricity. After two encouraging pilot studies totaling 204 uses in 2 district hospitals and 4 health centers in rural Rwanda, the investigators aim to further study the warmer in a stepped wedge prospective controlled trial in hospital setting to assess safety and efficacy of the Infant Warmer based on clinical observation and feasibility based on observer audits.

NCT ID: NCT03409770 Active, not recruiting - Clinical trials for Neonatal Encephalopathy

Optimising the Duration of Cooling in Mild Encephalopathy

COMET
Start date: October 10, 2019
Phase: N/A
Study type: Interventional

Phase II randomised control trial of whole body cooling in mild neonatal encephalopathy.

NCT ID: NCT03141723 Completed - Preterm Infant Clinical Trials

Kangaroo Mother Care With Plastic Bag (Trials 2A & 2B)

Start date: May 19, 2017
Phase: N/A
Study type: Interventional

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) thermoregulation care reduces the incidence of moderate (32-36° C) or severe (<32.0° C) hypothermia in term infants ≥ 37 0/7 weeks of gestational age (GA) when compared to KMC as continuously as possible together with routine WHO thermoregulation care.

NCT ID: NCT03031431 Completed - Clinical trials for Hypothermia Neonatal

Electricity-free Infant Warmer for Newborn Thermoregulation in Rwanda

Start date: July 2016
Phase: N/A
Study type: Interventional

Hypothermia contributes to a significant portion of neonatal deaths. Kangaroo mother care (KMC) is a safe and effective method of warming; however, it is not always feasible, and not possible in settings such as resuscitation or clinical instability. Electric warmers are the standard of care in developed countries, but are extremely costly, complicated with risk of causing both hypo and hyperthermia with misuse, and often not feasible in settings without stable electricity. Through a multi-institutional collaboration, the investigators have developed an electricity-free infant warmer. After laboratory based prototype testing for safety and efficacy, the investigators aim to study the supervised use of the warmer under routine implementation conditions in a resource-limited setting.