Electricity-free Infant Warmer for Newborn Thermoregulation in Rwanda

NCT03031431 | Completed Results DMC

• 1 other identifier: IRB-P00016205
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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, 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.

Conditions

Hypothermia Neonatal

Keywords

Hypothermia; Infant Warmer

Outcome Measures

Primary Outcomes (1)

• Temperature/Effectiveness

  The infant warmer will be evaluated on the number of time is able to successfully achieve and maintain a normal body temperature for patients who are hypothermic and those patients at risk of hypothermia because of a \< 2.5 kg birth weight or \< 35 week gestational age.

  Up to 6 months

Secondary Outcomes (3)

• Usability

  Up to 6 months

• Functionality

  Up to 6 months

• Qualitative Survey

  Up to 1 year

Study Arms (1)

Non-Electric Infant Warmer

EXPERIMENTAL

In line with current recommended practice, mothers will be encouraged to provide Kangaroo Mother Care (KMC) whenever possible. If an infant's temp is not rising by ½ degree C per hour with KMC alone, the infant warmer will be offered as an addition by the study team. If the mother is not available for KMC at any time, the infant will be warmed exclusively with the warmer. Bundling in clothes will only be used in addition to the warmer per carer preference. Temp measurement of the infant, warmer, and ambient air will be measured every 15 mins for the first hr, then hrly and as needed for the remainder of use or until warmer endpoint is reached (warmer temp below 36 degrees or phase-change material hardens \[soft, semisoft, or hardened\]).

Device: Non-Electric Infant Warmer

Interventions

Non-Electric Infant Warmer DEVICE

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.

Non-Electric Infant Warmer

Eligibility Criteria

• Age: Up to 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Any infant with the following criteria for whom caregiver is not available for Kangaroo Mother Care, or Kangaroo Mother Care is not adequate (less than ½ degree Celsius per hour rise in temperature).
• axillary temperature \< 36 degrees C and ≥35 degrees C 1a) If an electric warmer is available and the infant's temperature is \< 35 degrees C, then the infant would start by being warmed on the electric warmer until the infant's temperature reaches 36 degrees C, then can start non-electric infant warmer use
• Infants at-risk for hypothermia (criteria: estimated post-menstrual age of \< 35 weeks or current body weight of \< 2.5 kg)

You may not qualify if:

• Any infant whose family is unwilling to consent to study.
• Mothers who are critically ill at the time of infant eligibility or deemed not medically stable by nursing staff to be approached for consent.
• Any infant with a contraindication to Kangaroo Mother Care (medical instability) and electrical heating source available.
• Any infant with initial temperature \< 35 degrees C and electrical heating source available.
• Infants within the first hour of admission to neonatal unit or first hour of life in maternity.
• Infants requiring phototherapy
• Infants with significant skin condition
• Infants with Hypoxic Ischemic Encephalopathy (HIE)
• Stopping Criteria:
• If an electric heating source is available, the infant will be taken off the study and warmed with an appropriate source of electric heat if the infant:
• Is hypothermic and temperature decreases on any measurement
• Is hypothermic and temperature does not begin to rise within 30 minutes
• Is hypothermic and not heating at a rate of \> ½ degree C per hour until temperature is \>36.5 degrees C
• Has a temperature that falls below 36 degrees C despite maximum exposure to the heat source
• Is ever considered to be too severely ill by the medical team to be safely cared for in the non-electric infant warmer.

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Ministry of Health, Rwanda: collaborator
• Rwandan Biomedical Counsel (RBC): collaborator
• Harvard Medical School (HMS and HSDM): collaborator
• Institute for Transformative Technologies (ITT): collaborator
• Brigham and Women's Hospital: collaborator
• Partners in Health: collaborator

Study Sites (1)

Dr Evrard Nahimana

Rwinkwavu, Rwanda

Location

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Anne Hansen
• Organization: Boston Children's Hospital

Anne.Hansen@childrens.harvard.edu

(617)-355-6027

Study Officials

• Anne Hansen, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 13, 2016
• First Posted: January 25, 2017
• Study Start: July 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: July 1, 2019
• Last Updated: January 13, 2020
• Results First Posted: January 13, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

RW (1)