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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.
Insights
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.
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.
Background:
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).
Methods:
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.
Discussion:
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.
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