None listed
Conditions
Brief summary
Humidified incubators are currently widely used in the care of premature infants to assist with thermal stability however, hypothermia continues to be a problem, as optimal thermal weaning practices remain unclear through lack of evidence The primary aim of this trial will be to compare ceasing humidification at day 8 of life versus a gradual weaning protocol on maintaining body temperatures between 36.5°C – 37.5°C. We suspect that premature infants may benefit from being nursed in a humidified environment for longer than the standard one week which is currently provided.
Interventions
Humidification of an incubator= adding sterile water to an incubator/ baby's enclosed cot. Humidity is used to maintain temperature and electrolyte stability
Current Practice: Preterm infants aged less than 28 weeks gestation are currently placed in a humidified incubator (at 80% humidity) from birth to approximately seven days of age. The bedside nursing clinician caring for the infant each shift will be responsible for administering and maintaining humidification into the incubator. Both the s
Humidification of an incubator= adding sterile water to an incubator/ baby's enclosed cot. Humidity is used to maintain temperature and electrolyte stability Current Practice: Preterm infants aged less than 28 weeks gestation are currently placed in a humidified incubator (at 80% humidity) from birth to approximately seven days of age. The bedside nursing clinician caring for the infant each shift will be responsible for administering and maintaining humidification into the incubator. Both the set and actual humidification levels are recorded by the bedside nurse every hour. Humidification is ceased on day eight of life. On the first set of observations on day 8 (00:01) the bedside nurse will cease or wean humidification as per the protocol (of 5% per day). In this study infants will be randomised to have their -humidification ceased completely on day 8 after completing 7 days of humidification and care as usual. - or to have their humidification weaned gradually (by 5% each day) from day 8 to day 14 when humidification will be ceased and care as usual. Members of the research team will offer extensive education about this study prior to commencement of the study. Consistency is currently being achieved with all preterm infants (less than 28 weeks) being nursed in 80% for the full first seven days of life. Research nurses allocated to this study, team leaders and the principal investigator will check each day to see which infants need to have their humidification levels changed at midnight and follow up with notes to the bedside nurse to ensure adherence to the protocol
Sponsors
Gillion Noreiks
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to 7 Days
Healthy volunteers
No
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.
Outcome results
None listed