Trial Outcomes & Findings for Electricity-free Infant Warmer for Newborn Thermoregulation in Rwanda (NCT NCT03031431)
NCT ID: NCT03031431
Last Updated: 2020-01-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
130 participants
Primary outcome timeframe
Up to 6 months
Results posted on
2020-01-13
Participant Flow
Unit of analysis: Encounters
Participant milestones
| Measure |
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 \[soft, semisoft, or hardened\]).
|
|---|---|
|
Overall Study
STARTED
|
130 204
|
|
Overall Study
COMPLETED
|
129 203
|
|
Overall Study
NOT COMPLETED
|
1 1
|
Reasons for withdrawal
| Measure |
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 \[soft, semisoft, or hardened\]).
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|---|---|
|
Overall Study
Infant removed by maternal request
|
1
|
Baseline Characteristics
Sex/Gender was not obtained or assessed
Baseline characteristics by cohort
| Measure |
Non-Electric Infant Warmer
n=130 Participants
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 \[soft, semisoft, or hardened\]).
|
|---|---|
|
Age, Customized
<37 weeks Gestation
|
21 Participants
n=130 Participants
|
|
Age, Customized
>=37 weeks gestation
|
51 Participants
n=130 Participants
|
|
Age, Customized
Missing/Not Known
|
58 Participants
n=130 Participants
|
|
Sex/Gender, Customized
Sex/Gender Unknown
|
0 Participants
Sex/Gender was not obtained or assessed
|
|
Region of Enrollment
Rwanda
|
130 Participants
n=130 Participants
|
|
Birth Weight
≥2500 g
|
15 Participants
n=130 Participants
|
|
Birth Weight
1501 g to ≤2500 g
|
96 Participants
n=130 Participants
|
|
Birth Weight
1001 g to ≤1500 g
|
15 Participants
n=130 Participants
|
|
Birth Weight
≤1000 g
|
1 Participants
n=130 Participants
|
|
Birth Weight
Missing
|
3 Participants
n=130 Participants
|
|
Age at First Encounter
1-7 days
|
29 Participants
n=130 Participants
|
|
Age at First Encounter
8-31 days
|
16 Participants
n=130 Participants
|
|
Age at First Encounter
32 days or more
|
8 Participants
n=130 Participants
|
|
Age at First Encounter
On Birthday
|
77 Participants
n=130 Participants
|
PRIMARY outcome
Timeframe: Up to 6 monthsThe 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.
Outcome measures
| Measure |
Non-Electric Infant Warmer
n=204 Encounters
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 \[soft, semisoft, or hardened\]).
|
|---|---|
|
Temperature/Effectiveness
Successfully reaches/maintains healthy temperature
|
179 Number of infant warmer uses
|
|
Temperature/Effectiveness
Fails to reach/maintain healthy temperature
|
4 Number of infant warmer uses
|
|
Temperature/Effectiveness
Not recorded
|
21 Number of infant warmer uses
|
SECONDARY outcome
Timeframe: Up to 6 monthsThe 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.
Outcome measures
| Measure |
Non-Electric Infant Warmer
n=204 Encounters
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 \[soft, semisoft, or hardened\]).
|
|---|---|
|
Usability
Deviation from recommended use
|
0 Encounters with non-electric warmer
|
|
Usability
No deviation from recommended use
|
204 Encounters with non-electric warmer
|
SECONDARY outcome
Timeframe: Up to 6 monthsThe functionality will be assessed by whether or not there appeared to be wear and tear on the infant warmer based on repeated use.
Outcome measures
| Measure |
Non-Electric Infant Warmer
n=12 Infant Warmers
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 \[soft, semisoft, or hardened\]).
|
|---|---|
|
Functionality
Showed wear and tear
|
5 infant warmers
|
|
Functionality
No wear and tear
|
7 infant warmers
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Zero participants were analyzed as the investigators ultimately decided not collect qualitative data.
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.
Outcome measures
Outcome data not reported
Adverse Events
Non-Electric Infant Warmer
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place