Justifying humidification management options for infants delivered extremely premature- when and why? A randomised controlled trial. (Y HUMIDIFY).

Humidification of an incubator- adding sterile water into an incubator (baby's enclosed cot) to increase the ambient relative humidity within. Current practice: Premature infants aged less than 28 weeks gestation are currently placed in a humidified incubator (at 80% humidity) from birth to 168 hours of life (seven full days). 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 at 168 hours of life and care as usual. In this study, infants will be nursed in 80% incubator humidity from birth and then if parents’ consent to their participation in the trial, they will be randomised to one of three different treatment groups/ arms for managing their incubator humidification -Arm 1 (the control arm) incubator humidification will be ceased at 168 hours (7 days) of life (current practice) and care as usual -Arm 2 (an intervention arm) incubator humidification will be ceased at 96 hours (4 days) of life and care as usual -Arm 3 ( an intervention arm) incubator humidification will be weaned by 10% daily from 96 hours of life to 168 hours of life and then ceased with care as usual. Members of the research team will offer extensive education about this study to neonatal intensive care staff prior to commencement of the study. Consistency is currently being achieved with all premature infants born less than 28 weeks' gestation being nursed in 80% incubator humidity for the first 168 hours of life. Research nurses allocated to this study, team leaders and/or the principal investigator will check each day to see which infants need their humidification levels changed and follow up with written notes to the bedside nurse to ensure adherence to the protocol. They will also determine if any new admissions meet the eligibility criteria to participate in the trial. Parental consent will be sought to permit eligible premature infants to participate in this trial. If parents do not which for their infant to participate in this trial the infant will be nursed in 80% incubator humidity for 168 hours as this is current practice. The maximum number of participants that will be asked to participate in this study is 378. To ensure compliance to the protocol and adherence to the intervention the following is planned: Each individual bedside clinician will be provided with one-on-one education about the trial and the details of each intervention will be explained in detail Individual and group education sessions and in-service will be provided to improve compliance with the protocol and permit questions to be answered. Beside each enrolled infant will be a folder containing • the protocol • the enrolment schema describing the three treatment arms • the relevant documentation and cot cards for the treatment arm the infant has been randomised to. Plus research staff will check each day to ensure adherence to the protocol by reviewing the bedside observation chart, reminding the bedside nurse of the planned intervention. Team leaders on each shift will examine the eligible participants randomisation and ensure the proposed intervention is being adhered to.