ハイリスク新生児における感覚運動刺激と機能的摂食を評価するランダム化試験：研究プロトコル

Adequate nutritional intake is necessary for optimal growth and development of high-risk newborns, specifically preterm infants and newborns with congenital diaphragmatic hernia (CDH). They face challenges initiating and advancing enteral and oral feeding, originating from mechanical dysfunction of gastrointestinal motility, which probably results from delayed or deviant maturation of the autonomous nervous system (ANS). This often leads to long-term feeding difficulties and failure to thrive. Antenatally, ANS development is influenced by various forms of sensorimotor stimulation. Postnatally, development may be delayed, partly due to reduced sensory inputs. A sensorimotor stimulation programme was developed directed at improving gastrointestinal functionality: HAPTOS (Handling Adapted to Postnatal age with Tactile-kinaesthetic and Oral sensorimotor Stimulation).

This multicentre, randomized clinical trial in preterm ( < 30 weeks gestation) and CDH infants compares standard care to HAPTOS in addition to standard care. Primary outcomes are postnatal age at full enteral feeding and postmenstrual age at full oral feeding. Secondary outcomes are short-term clinical outcomes, short-term autonomic regulation, short-term care and parental participation, long-term growth and wellbeing, and long-term neurodevelopment.

This study evaluates HAPTOS: a novel concept of developmental care to improve functional outcomes in high-risk newborns IMPACT: High-risk newborns often present with immature gastrointestinal motility, leading to challenges initiating and progressing with enteral and oral feeding with long-term sequelae. Sensorimotor stimulation has positive effects on feeding outcomes but current protocols are unsuitable for high-risk newborns. Thus, a new sensorimotor stimulation programme was developed: HAPTOS (Handling Adapted to Postnatal age with Tactile-kinaesthetic and Oral sensorimotor Stimulation). This randomized controlled trial assesses clinical effects of HAPTOS and provides evidence for the role of autonomic regulation in functional maturation. HAPTOS intervention is a novel concept of developmental care to improve gastrointestinal outcomes and overall wellbeing in high-risk newborns.