Humidification weaning practices may impact infants born prematurely: a randomised controlled trial. (HUMIDITY Trial)

Not Applicable

Completed

• Conditions: Hypothermia in premature infants; Hypernatraemia in premature infants; Reproductive Health and Childbirth - Complications of newborn

• Registration Number: ACTRN12619000266167
• Lead Sponsor: Gillion Noreiks

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-21
• Study Completion: 2022-08-17
• Last Update Posted: 19 September 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

Be aged greater than or equal to 23 weeks’ gestation but less than or equal to 27.6 weeks’ gestation,
Be no more than seven completed days of age at the time of recruitment,
Be nursed in an incubator,
Commence the planned intervention on day eight,
Be either inborn at the RBWH or out born,
Be expected to survive the first 14 days of life,
Have parents who can communicate effectively in the English language,
Have parents who will be provided with a patient information consent form (PICF) outlining the study at an appropriate time prior to day seven of life.

Exclusion Criteria

Those with known or suspected chromosomal abnormalities,
Those with major congenital abnormalities,
Those with significant surgical conditions- specifically abdominal wall defects,
Those that need to be transferred out of the incubator to an open care system for ongoing management,
Those who have parents who have declined to permit participation,
Those infants considered too sick to seek parental consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified