Efficacy of Sunflower Technique versus conventional care in reducing the risk of unplanned extubation in newborns: a pilot randomized cross-over trial.

Unplanned extubation (UE) is a common and largely preventable safety event in neonatal intensive care units, with agitation, hand-to-endotracheal tube (ETT) interaction, and subsequent staff intervention frequently preceding events. This study aimed to evaluate the short-term efficacy of the Sunflower Technique (SFT), a non-pharmacological developmental containment intervention, in reducing agitation, behaviors related to self-extubation, and the need for staff intervention in invasively ventilated neonates. In this pilot randomized cross-over trial, intubated neonates of any gestational age underwent two 1-h observation periods on the same day, receiving SFT and conventional care (CC) in randomized order (30 min each during both 1 h periods). Primary outcomes included near-miss self-extubation events (grabbing the ETT), possible self-extubation events (touching the tube), agitation assessed using the Neonatal Pain, Agitation, and Sedation Scale (N-PASS) and COMFORTneo scales. Secondary outcome included frequency of staff intervention. All observation periods were video-recorded for assessment. Fifty-seven neonates contributed 114 observation periods for each group. Compared with CC, SFT was associated with significantly fewer near-miss and possible self-extubation events (P < .001 for both). Agitation scores were significantly lower during SFT periods on both N-PASS and COMFORTneo scales (P < .001). No UE events occurred during either period. No interventions needed by staff were comparable during SFT and CC periods (72.8% vs. 61.4%, P = .059). The SFT was associated with reduced agitation, fewer behaviors related to self-extubation, and a comparable need for staff intervention in invasively ventilated neonates.