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Randomized trial evaluating sensorimotor stimulation and functional feeding in high-risk newborns: study protocol.

Marit L Nelissen¹, Viola Christmann², Marysia van Gestel²

¹Department of Pediatrics, Division of Neonatology, Radboudumc Amalia Children's Hospital, Nijmegen, The Netherlands. marit.nelissen@radboudumc.nl.

Pediatric Research

|December 19, 2025

Summary

Handling Adapted to Postnatal age with Tactile-kinaesthetic and Oral sensorimotor Stimulation (HAPTOS) improves feeding in high-risk newborns. This intervention enhances gastrointestinal function and overall wellbeing in preterm infants and those with congenital diaphragmatic hernia.

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Area of Science:

Neonatal care
Developmental pediatrics
Gastroenterology

Background:

High-risk newborns, including preterm infants and those with congenital diaphragmatic hernia (CDH), often experience feeding difficulties due to immature gastrointestinal motility and autonomic nervous system (ANS) dysfunction.
Delayed or deviant ANS maturation can lead to long-term feeding challenges and failure to thrive.
Sensorimotor stimulation can positively influence ANS development and gastrointestinal function, but existing protocols are not always suitable for high-risk neonates.

Purpose of the Study:

To evaluate the clinical effects of HAPTOS (Handling Adapted to Postnatal age with Tactile-kinaesthetic and Oral sensorimotor Stimulation), a novel sensorimotor stimulation program.
To assess HAPTOS's impact on improving gastrointestinal functionality and overall outcomes in high-risk newborns.
To provide evidence for the role of autonomic regulation in the functional maturation of these infants.

Main Methods:

A multicentre, randomized clinical trial involving preterm infants (<30 weeks gestation) and infants with CDH.
Comparison of standard care versus standard care plus the HAPTOS intervention.
Primary outcomes: postnatal age at full enteral feeding and postmenstrual age at full oral feeding.

Main Results:

The study aims to assess the clinical effects of HAPTOS.
It will evaluate short-term clinical outcomes, autonomic regulation, care, and parental participation.
Long-term growth, wellbeing, and neurodevelopment will also be assessed.

Conclusions:

HAPTOS represents a novel concept in developmental care designed to enhance functional outcomes in high-risk newborns.
The intervention targets the improvement of gastrointestinal outcomes and overall wellbeing.
This randomized controlled trial will offer evidence supporting the use of HAPTOS for improving feeding and development in vulnerable infants.