None listed
Conditions
Brief summary
The purpose of the study is to investigate whether specific positioning of the preterm baby’s head in the first 72 hours of life will reduce brain bleeds and lead to improved developmental outcomes. The first stage is to determine whether this study is acceptable to parents and whether it is possible to recruit preterm babies in the first four hours of life when the delivery is often an emergency situation. We hypothesize that the study will be acceptable to parents and that it will be possible to recruit babies within the four hour time frame. Babies born less than 29 weeks gestation will receive either usual positioning practice for the first 72 hours or the optimal positioning group. For the usual positioning group, there is currently no standard way to position the preterm baby for the first 72 hours. Babies in the optimal positioning group will be placed on a slightly tilted surface, on their back and with their head in the centre, for 72 hours. The head will be placed on a special pillow designed to mould to the baby’s head and keep the position stable during this time. Brain oxygen levels and presence of brain bleeds will be measured.
Interventions
Intervention studied is optimal head positioning practice for preterm infants in the first 72 hours of life in the Neonatal Intensive Care Unit.
This is a pilot study to determine the feasibility of a randomised controlled trial in terms of whether the recruitment and consenting process is acceptable to parents and practical within fours of delivery which is frequently an emergency situation.
Infants will be nursed on a tilted surface up to 30° (ie. full tilt of Giraffe incubator tray plus pos
Intervention studied is optimal head positioning practice for preterm infants in the first 72 hours of life in the Neonatal Intensive Care Unit. This is a pilot study to determine the feasibility of a randomised controlled trial in terms of whether the recruitment and consenting process is acceptable to parents and practical within fours of delivery which is frequently an emergency situation. Infants will be nursed on a tilted surface up to 30° (ie. full tilt of Giraffe incubator tray plus positioning pillow determined at nurses discretion) and positioned supine with head in midline for the first 72 hours of life. A freestanding patient positioning mould (Z-Flo™ neonatal positioner) will keep the head in a stable and consistent position including supporting the base of the occiput to prevent forward flexion of the head/neck to reduce likelihood of airway obstruction. The positioner has a low friction/shear surface, maximum contouring ability for moulding to accommodate tubing/wires, and zero memory ensuring it does not move once moulded. The infant will be briefly moved to sidelying position with head in neutral midline, every four hours to check skin integrity. A laminated chart will be placed on the crib to remind staff of position for each infant. A checklist will be completed by the nurse at the end of each shift to check head position and probe attached, documentation of any problems encountered and removal of positioner etc. Bedside nurse will report changes in head position for unavoidable medical indications and record duration of changes. Research nurse will conduct compliance audit prior to the study and compliance during the study.
Sponsors
Western Sydney Local Health District
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
0 to 4 Hours
Healthy volunteers
No
Inclusion criteria
1. Gestational age <29 weeks 2. Postnatal age <4 hours 3. Parent consent within 4 hours
Exclusion criteria
1. Exutero transfer 2. Presence of lethal congenital anomalies 3. Serious congenital cardiac disease 4 Pre-existing intraventricular haemorrhage (determined on baseline cranial ultrasound) 5. Parent not consenting for study
Outcome results
None listed