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Clinical Trials/ISRCTN14899342
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

Sponsor
mOm Incubators limited

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