Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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. The Infant Warmer the investigators propose to study has previously been tested in 2 pilot studies totaling 204 uses, occurring in 2 district hospitals and 4 health centers in rural Rwanda. The combined results of these pilot studies were extremely encouraging. This study will be 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. A total of 10 district hospitals will participate in the study. All 10 hospitals will start with a 2 week period of observation in which "pre" data will be collected. Hospitals will then receive the warmer and be transitioned to the "post" period at a rate of one every two weeks. The primary study aim is to assess the safety, efficacy and feasibility of the Infant Warmer as an addition to KMC, and to achieve and maintain euthermia when KMC is inadequate or unavailable. The study will be conducted across a wide range of district hospitals with control data coming from pre-intervention period and treatment data coming from post intervention period, with the intervention being the introduction of the Infant Warmer. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03890211
Study type Interventional
Source Boston Children's Hospital
Contact
Status Active, not recruiting
Phase N/A
Start date November 11, 2019
Completion date January 1, 2022

See also
  Status Clinical Trial Phase
Active, not recruiting NCT03409770 - Optimising the Duration of Cooling in Mild Encephalopathy N/A
Active, not recruiting NCT06141252 - Benefit of Hypothermia in OHCA Complicating AMI N/A
Completed NCT03141723 - Kangaroo Mother Care With Plastic Bag (Trials 2A & 2B) N/A
Completed NCT06277843 - Low-Cost and Reusable Thermal Jacket for Managing Preterm or Low Birth Weight Neonates. Early Phase 1
Completed NCT03031431 - Electricity-free Infant Warmer for Newborn Thermoregulation in Rwanda N/A
Recruiting NCT05574855 - Evaluation of Haemodynamic in Neonates Treated With Hypothermia"