ISRCTN14899342Completed未知
Comparison of the mOm incubator with a standard incubator for the maintenance of thermal stability in infants in infants (=6 kg)
mOm Incubators limited0 sites43 target enrollmentStarted: April 16, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 43
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Current inclusion criteria as of 29/11/2021:
- •1. Parent/legal guardian is willing and able to give informed consent for participation in the study
- •2. Parent/legal guardian is aged 16 years or above
- •3. Participant considered clinically stable from a cardiorespiratory point of view
- •4. Participant requires incubator care but do not require additional humidification
- •5. Participant requires incubator care for at least 48 hours.
- •6. Participant is at least 30 weeks gestational age.
- •7. Participant weighs 6 kg or less
- •Previous inclusion criteria:
- •1. Parent/legal guardian is willing and able to give informed consent for participation in the study
- •2. Parent/legal guardian is aged 16 years or above
- •3. Participant considered clinically stable from a cardiorespiratory point of view
- •4. Participant requires incubator care but do not require additional humidification
- •5. Participant requires incubator care for at least 48 hours.
- •6. Participant is at least 30 weeks gestational age.
- •7. Participant is less than 8 kg in weight
Exclusion Criteria
- •1. Parent/legal guardian with learning disabilities or mental illness and are considered unable to give informed consent
- •2. Parent/legal guardian is a prisoner or young offender
- •3. Parent/legal guardian is considered to have a particularly dependent relationship with the investigator(s)
- •4. Parent/legal guardian is deemed to belong to a vulnerable group
Investigators
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