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.