572 - Midline Head Position for Infants Born Prematurely in the First 72 Hours of Life: A Pilot Randomized Controlled Trial

Publication Number: 572.5844

Traci-Anne Goyen, Westmead Hospital, Westmead, New South Wales, Australia; Hannah Skelton, Western Sydney University, Sydney, New South Wales, Australia; Daphne D'Cruz, Westmead Hosptial, Westmead, New South Wales, Australia; Rajesh Maheshwari, The University of Sydney, Sydney, New South Wales, Australia; Bronwyn Edney, Physiotherapy Westmead hospital, Wentworthville, New South Wales, Australia; Patricia M. Viola, Westmead Hospital, Blacktown, New South Wales, Australia; Melissa Luig, Westmead Hospital, Westmead, New South Wales, Australia; Dharmesh Shah, University of sydney, Sydney, New South Wales, Australia; Pranav Jani, Westmead Hospital and University of Sydney, Westmead, New South Wales, Australia

Background: Despite minimal evidence, intraventricular hemorrhage (IVH) prevention bundles for infants born prematurely in the first 72 hours, frequently include midline head positioning as a neuroprotective strategy. Previous randomized controlled trials (RCT) had difficulty with recruitment.

Objective: This pilot study explored the feasibility of conducting a RCT to inform future trials, on the effects of midline head positioning for the first 72 hours in infants delivered < 29 weeks gestation. We examined (1)acceptability of the recruitment and consenting process, (2)practicality of recruitment within 4 hours of life, (3)protocol compliance, and (4)staff satisfaction with the intervention.

Design/Methods: An open-label, single center, balanced 1:1 allocation, parallel-group pilot RCT was adopted. Sixty (n=60) inborn infants delivered < 29 weeks and admitted to a single NICU were eligible if there was no IVH on screening ultrasound and if parental consent was obtained antenatally or within 4 hours of birth. Exclusion criteria: outborn infants, lethal congenital anomaly, or serious congenital cardiac disease. Infants were randomized to either midline head position with support and body supine (intervention) or variable position (control) for the first 72 hours of life, stratified according to gestation (Group 1: 23+0/7–25+6/7 or Group 2: 26+0/7–28+6/7 weeks). Feasibility measures were (1)recruitment rate, (2)time to complete recruitment, (3)protocol compliance audit, and (4)staff satisfaction survey.  Safety measures were (1)physiological stability (accidental extubation, apnea requiring intubation, hypotension requiring inotropes), (2)skin integrity (Neonatal Skin Condition Score), (3)pain (Neonatal Pain Assessment Tool), (4)comfort (COMFORT-neo), and (5)early head preference (Head Turn Preference Scale).

Results: Sixty participants were enrolled with successful recruitment rate of 67% (60/89 potential participants). Results summarized in Table 1. Recruitment and intervention were commenced for all participants by 6 hours of life (76% by 4 hours and 100% by 6 hours). Compliance with intervention protocol was 98% for maintaining midline head position and 84% for crib tilt. Nursing satisfaction with the intervention was positive in 30/33 (91%). No safety issues with the intervention were found (Table 2).

Conclusion(s): It is feasible and safe to conduct a RCT to examine the neuroprotective effects of midline head positioning for infants born prematurely in the first 72 hours of life. Alterations to the study protocol will optimize recruitment rate and time.

Table 1: Summary of Feasibility Outcomes for Study Groups


Table 2: Summary of Safety Outcomes for Study Groups