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

NCT03890211 | Unknown DMC

• 1 other identifier: IRB-P00030705
• Study Type: interventional
• Target: 3,179
• 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, 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.

Conditions

Hypothermia Neonatal

Keywords

Hypothermia; Infant Warmer

Outcome Measures

Primary Outcomes (2)

• Ability to regulate infant body temperature

  The infant warmer will be evaluated on its ability to 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. Infants temperature will be measured, using a thermometer to ensure the body temperature will increase but not exceed 37.5°C.

  up to 6 months

• Incidence of adverse events as assessed by staff observation

  The investigators will assess the safety of the infant warmer by observing any adverse reactions such as skin irritations or higher than usual patient temperature (\>37.5°C). The safety of the warmer will be measured by study staff observation, measuring the temperature of the warmer with a thermistor instrument, measuring the infant's temperature with a thermometer, as well an investigator-developed Observer Audit Form. The Observer Audit Form is a battery of nine questions which includes eight yes/no questions and one free response. The questions evaluate such topics as whether the warmer was cleaned, the infant was positioned correctly, if adverse events were present, etc.

  up to 6 months

Secondary Outcomes (2)

• Studying the practicality of applying the device in a clinical setting

  up to 6 months

• Functionality

  up to 6 months

Study Arms (2)

Non-Electric Infant Warmer

EXPERIMENTAL

In line with current recommended practice, the mother will be encouraged to provide KMC whenever possible. For hypothermic infants, if the temperature is not rising by ½°C per hour with KMC alone, the Infant Warmer will be offered as an addition. In these cases, the heat will be provided by placing the Infant Warmer over the infant's back while the mother provides KMC. If the mother is not available for KMC at any time, the infant will be warmed exclusively with the Infant Warmer by being placed directly on the warmer as it lies flat. Use of hat and socks will be encouraged by additional clothes will only be added in addition to the warmer per caregiver request, as it reduces heat transfer.

Device: Non-Electric Infant Warmer

Control

NO INTERVENTION

Data such as infant temperature, date of birth, etc. will be collected from those who enroll in the control group. No experimental intervention will be administered.

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: 0 Days - 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 not available for KMC, or KMC is not adequate (less than 0.5°C/hour rise in temperature):
• Axillary temperature \< 36.5 °C
• a) If an electric warmer is available and the infant's temperature is \< 35°C, then the infant will start by being warmed on the electric warmer until the infant's temperature reaches 36°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 the 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 KMC (medical instability) and electrical heating source available.
• Any infant with initial temperature \< 35°C and electrical heating source available.
• Infants requiring phototherapy.
• Infants with significant skin condition.
• Stop Criteria:
• If an electric heating source is available, the infant will be taken off of the study and warmed with an appropriate source of electric heat if the infant:
• If an electric heating source is available, the infant will be taken off of the study and warmed with an appropriate source of electric heat if the infant:
• i. Has temp \< 36 °C while receiving maximum non-electric heat exposure and temperature decreases on any measurement ii. Has temp \< 36 °C while receiving maximum non-electric heat exposure and temperature does not begin to rise within 30 minutes iii.Has temp \< 36 °C while receiving maximum non-electric heat exposure and not heating at a rate of \> ½ °C per hour until temperature \>36.5°C iv.Has a temperature that falls below 36°C despite maximum non-electric heat exposure
• Definition of maximum non-electric heat exposure:
• IW, KMC, hat; if KMC available
• IW, blanket, hat; if KMC not available
• Blanket, hat; while seeking caregiver for KMC and/or preparing IW if KMC and IW not available
• Has temperature \> 37.5 °C

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Ministry of Health, Rwanda: collaborator
• Rwandan Biomedical Counsel (RBC): collaborator
• Harvard Medical School (HMS and HSDM): collaborator
• Partners in Health: collaborator
• Rwanda National Ethics Committee (RNEC): collaborator
• Lawrence Berkeley National Laboratory: collaborator

Study Sites (1)

Dr Evrard Nahimana

Rwinkwavu, Rwanda

Location

Related Publications (1)

• Uwamariya J, Mazimpaka C, May L, Nshimyiryo A, Feldman HA, Sayinzoga F, Umutesi S, Gadgil A, Rapp VH, Nahimana E, Hansen A. Safety and effectiveness of a non-electric infant warmer for hypothermia in Rwanda: A cluster-randomized stepped-wedge trial. EClinicalMedicine. 2021 Apr 16;34:100842. doi: 10.1016/j.eclinm.2021.100842. eCollection 2021 Apr.

  PMID: 33997734 DERIVED

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

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

Study Officials

• Anne Hansen, MD, MPH

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director of Neonatal Intensive Care Unit

Study Record Dates

• First Submitted: March 21, 2019
• First Posted: March 26, 2019
• Study Start: November 11, 2019
• Primary Completion: July 19, 2020
• Study Completion: January 1, 2022
• Last Updated: February 11, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

RW (1)