Hypothermia NeonatalNCT03890211
Trial of a Non Electric Infant Warmer for Prevention and Treatment of Hypothermia in Rwanda
A study testing Non-Electric Infant Warmer in people with Hypothermia Neonatal, run by Boston Children's Hospital at 1 site in Rwanda.
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. Read more about this study
- Who is it for?
- Ages 0 days to 3 months
- Conditions the study is for
- Hypothermia Neonatal
- What is being tested?
- Non-Electric Infant Warmer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,179 participants
- Where
- 1 siteRwanda
- Study dates
- 11 Nov 2019to 1 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
- 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).
Who cannot join
- 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.
Show all 17Show fewer
- 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:
- 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
- Is ever considered to be too severely ill by the medical team to be safely cared for in the non-electric Infant Warmer.
- The warmer will be removed once its temperature drops below phase change temperature as assessed by noting that the material begins to harden and turn white and is no longer warm in area under where baby is lying.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stepped Wedge Randomized Control Trial of a Non Electric Infant Warmer for Prevention and Treatment of Hypothermia in Rwanda
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.
Read the 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, 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.
- Conditions
- Hypothermia Neonatal
- Being tested
- Non-Electric Infant Warmer
- Keywords
- Hypothermia, Infant Warmer
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Electric Infant WarmerDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: up to 6 months
Secondary outcomes (2)
Studying the practicality of applying the device in a clinical setting
The investigators will use observation to evaluate the usability of the warmer by assessing the way that the infant is placed on the warmer and any adverse effects of infant warmer use. This will be measured by study staff observation 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.
Measured: up to 6 months
Functionality
The functionality will be assessed by the way that the warmer is prepared and cleaned, as well as any wear and tear on the warmer based on repeated use. Functionality will be measured by study staff observation as well an investigator-developed Observer Audit Form. The Observer Audit Form is a battery of eight questions which includes seven 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.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start11 Nov 2019
- Primary completion19 Jul 2020
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypothermia NeonatalStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Rwanda, Rwandan Biomedical Counsel (RBC), Harvard Medical School (HMS and HSDM), Partners in Health, Rwanda National Ethics Committee (RNEC), Lawrence Berkeley National Laboratory
- Responsible party
- Principal investigator, Anne Hansen, Boston Children's Hospital
- Investigators
- Anne Hansen, MD, MPH, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03890211
- Sponsor's protocol ID
- IRB-P00030705
- Status last verified
- Feb 2021
- First submitted
- 21 Mar 2019
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33997734
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stepped Wedge Randomized Control Trial of a Non Electric Infant Warmer for Prevention and Treatment of Hypothermia in Rwanda
- ClinicalTrials.gov ID
- NCT03890211
- Acronym / sponsor ID
- IRB-P00030705
- Conditions
- Hypothermia Neonatal
- Keywords
- Hypothermia, Infant Warmer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,179 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health, Rwanda, Rwandan Biomedical Counsel (RBC), Harvard Medical School (HMS and HSDM), Partners in Health, Rwanda National Ethics Committee (RNEC), Lawrence Berkeley National Laboratory
- Study start
- 11 Nov 2019 (actual)
- Primary completion
- 19 Jul 2020 (actual)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 26 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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, 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
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Electric Infant Warmer | Experimental | Device: Non-Electric Infant WarmerIn 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. |
| 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. |
Who may qualify
- Ages
- 0 days to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
- Infants at-risk for hypothermia (criteria: estimated post-menstrual age of < 35 weeks or current body weight of < 2.5 kg).
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Electric Infant WarmerElectric 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. | Device | Non-Electric Infant Warmer |
Primary outcome
Ability to regulate infant body temperature
Time frame: up to 6 months
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.
Incidence of adverse events as assessed by staff observation
Time frame: up to 6 months
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.
2 secondary outcomes
Studying the practicality of applying the device in a clinical setting
Time frame: up to 6 months
Functionality
Time frame: up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- Derived from this study: PubMed 33997734Uwamariya 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Hansen, MD, MPH principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Electric Infant Warmer in people with Hypothermia Neonatal, run by Boston Children's Hospital at 1 site in Rwanda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Rwanda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability to regulate infant body temperature (time frame: up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03890211, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2021.