Hypothermia Neonatal
Conditions
Keywords
Hypothermia, Infant Warmer
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.
Detailed 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, 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. The primary aim of Phase 1 is to determine if the infant warmer is a safe, effective, usable and functional addition to KMC. This is planned in a convenience sample of patients in two district hospitals, one in a relatively warm environment, and one in a colder setting using quantitative methods and observer audits of usability and functionality. After determination of safety and effectiveness and making any necessary modifications to the warmer, Phase 2 aims to study the warmer in rural health centers and transport, as this is where we ultimately aim to use the electricity free devices due to the limited access to functioning and stable electricity in these settings. The overall goal of the project is dissemination of the study results, and ultimately the infant warmer to the district and national level for key policy makers and stakeholders, as well as globally via publication.
Interventions
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.
Sponsors
Ministry of Health, Rwanda
Rwandan Biomedical Counsel (RBC)
Harvard Medical School (HMS and HSDM)
Institute for Transformative Technologies (ITT)
Brigham and Women's Hospital
Partners in Health
Boston Children's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 3 Months
Healthy volunteers
No
Inclusion criteria
* 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). 1. 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 2. Infants at-risk for hypothermia (criteria: estimated post-menstrual age of \< 35 weeks or current body weight of \< 2.5 kg)
Exclusion criteria
1. Any infant whose family is unwilling to consent to study. 2. Mothers who are critically ill at the time of infant eligibility or deemed not medically stable by nursing staff to be approached for consent. 3. Any infant with a contraindication to Kangaroo Mother Care (medical instability) and electrical heating source available. 4. Any infant with initial temperature \< 35 degrees C and electrical heating source available. 5. Infants within the first hour of admission to neonatal unit or first hour of life in maternity. 6. Infants requiring phototherapy 7. Infants with significant skin condition 8. 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: 1. Is hypothermic and temperature decreases on any measurement 2. Is hypothermic and temperature does not begin to rise within 30 minutes 3. Is hypothermic and not heating at a rate of \> ½ degree C per hour until temperature is \>36.5 degrees C 4. Has a temperature that falls below 36 degrees C despite maximum exposure to the heat source 5. Is ever considered to be too severely ill by the medical team to be safely cared for in the non-electric infant warmer. 6. The warmer will be removed once its temperature drops below 36 degrees, and/or the phase change material begins to harden.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Temperature/Effectiveness | Up to 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Usability | Up to 6 months | The investigators will use observation to evaluate the usability of the warmer by assessing whether or not the infant warmer was used in a way that deviated from its recommended use. |
| Functionality | Up to 6 months | The functionality will be assessed by whether or not there appeared to be wear and tear on the infant warmer based on repeated use. |
| Qualitative Survey | Up to 1 year | The same as primary outcome and secondary outcome as described above with the setting being clinic and transport based rather than in a hospital, and with the addition of qualitative questions for mother and nurse regarding infant warmer use. |
Countries
Rwanda
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Non-Electric Infant Warmer 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 \[soft, semisoft, or hardened\]). | 130 |
| Total | 130 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Infant removed by maternal request | 1 |
Baseline characteristics
| Characteristic | Non-Electric Infant Warmer | — |
|---|---|---|
| Age at First Encounter 1-7 days | 29 Participants | — |
| Age at First Encounter 32 days or more | 8 Participants | — |
| Age at First Encounter 8-31 days | 16 Participants | — |
| Age at First Encounter On Birthday | 77 Participants | — |
| Age, Customized >=37 weeks gestation | 51 Participants | — |
| Age, Customized <37 weeks Gestation | 21 Participants | — |
| Age, Customized Missing/Not Known | 58 Participants | — |
| Birth Weight ≤1000 g | 1 Participants | — |
| Birth Weight 1001 g to ≤1500 g | 15 Participants | — |
| Birth Weight 1501 g to ≤2500 g | 96 Participants | — |
| Birth Weight ≥2500 g | 15 Participants | — |
| Birth Weight Missing | 3 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Rwanda | 130 Participants | — |
| Sex/Gender, Customized Sex/Gender Unknown | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 130 |
| other Total, other adverse events | 0 / 130 |
| serious Total, serious adverse events | 0 / 130 |
Outcome results
Primary
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.
Time frame: Up to 6 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non-Electric Infant Warmer | Temperature/Effectiveness | Successfully reaches/maintains healthy temperature | 179 Number of infant warmer uses |
| Non-Electric Infant Warmer | Temperature/Effectiveness | Fails to reach/maintain healthy temperature | 4 Number of infant warmer uses |
| Non-Electric Infant Warmer | Temperature/Effectiveness | Not recorded | 21 Number of infant warmer uses |
Secondary
Functionality
The functionality will be assessed by whether or not there appeared to be wear and tear on the infant warmer based on repeated use.
Time frame: Up to 6 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non-Electric Infant Warmer | Functionality | Showed wear and tear | 5 infant warmers |
| Non-Electric Infant Warmer | Functionality | No wear and tear | 7 infant warmers |
Secondary
Qualitative Survey
The same as primary outcome and secondary outcome as described above with the setting being clinic and transport based rather than in a hospital, and with the addition of qualitative questions for mother and nurse regarding infant warmer use.
Time frame: Up to 1 year
Population: Zero participants were analyzed as the investigators ultimately decided not collect qualitative data.
Secondary
Usability
The investigators will use observation to evaluate the usability of the warmer by assessing whether or not the infant warmer was used in a way that deviated from its recommended use.
Time frame: Up to 6 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non-Electric Infant Warmer | Usability | Deviation from recommended use | 0 Encounters with non-electric warmer |
| Non-Electric Infant Warmer | Usability | No deviation from recommended use | 204 Encounters with non-electric warmer |