Improving Gastrointestinal Function In High-Risk Newborns By Stimulation Of The Enteric Nervous System

Not Applicable

Recruiting

• Conditions: Feeding and Eating Disorders
• Interventions: Procedure: HAPTOS (Handling Adapted to Postnatal age with Tactile-kinaesthetic and Oral sensorimotor Stimulation

• Registration Number: NCT06057415
• Lead Sponsor: Radboud University Medical Center

Brief Summary

The goal of this therapeutical intervention trial is to investigate whether tactile-kinesthaetic and oral sensorimotor stimulation can improve gastrointestional function in preterm infants born before gestational age of 30 weeks and newborns with congenital diaphragmatic hernia. The main question it aims to answer is:

• To determine whether HAPTOS- intervention (Handling Adapted to Postnatal age with Tactile-kinaesthetic and Oral sensorimotor Stimulation) in the particpants results in earlier attainment (postnatal days) of full enteral feeding and/or full oral feeding (post menstrual age) compared to standard care. Researchers will compare an intervention group receiving standard of care plus HAPTOS intervention to a group of patients receiving only current standard of care.

Detailed Description

Infants born preterm or with congenital diaphragmatic hernia (CDH) are at risk for several long-term unfavourable outcomes that can be related to feeding difficulties from birth onwards. Adverse nutritional outcomes in both patient groups mainly originate from mechanical dysfunction, based on dysmotility. Mechanical function includes suck-swallow coordination, gastrointestinal sphincter tone, gastric emptying and intestinal motility and is regulated by the complex interplay of the autonomic (ANS) and enteric (ENS) nervous system with modulation by the central nervous system (CNS). The intra-uterine environment provides the fetus with developmentally timed sensory exposures through 'touch' that are necessary for development of sensory control and autonomous coordination of bodily functions. Preterm infants miss out this normal maturation, while newborns with CDH may exhibit a delayed maturation probably as a result of the deviant anatomical situation and the severe illness during the direct postnatal period. In the postnatal situation both patient groups may be confronted with either 'negative' sensory stimulation through exposures such as procedural touch/handling, pain or otherwise a reduction in sensory exposures through avoidance of positive touch in relation to supposed clinical instability. All together this may affect normal development and may lead to sensory deprivation and delayed maturation of the nervous regulation and cerebral maturation. Tactile-kinaesthetic and oral sensorimotor stimulation using positive gentle touch have been shown to positively affect cardiorespiratory stability, weight gain, gastro-intestinal performance, and length of stay in hospital for preterm infants. However, these strategies have not been evaluated in high-risk infants. The current study aims at evaluating an intervention programme that provides positive stimuli through touch adapted to the stage of development of the infant with regard to timing, duration and intensity that supports the maturational development of gastrointestinal functionality. (Handling Adapted to Postnatal age with Tactile-kinaesthetic and Oral sensorimotor Stimulation; HAPTOS intervention). We hypothesize that the HAPTOS intervention will improve the postnatal maturation of the autonomous and enteral nervous system and cause improvements in gastrointestinal motility, enteral and oral feeding and cardiorespiratory stability.

Study Timeline

• Study First Submitted: 2023-06-21
• Study First Submitted QC: 2023-09-21
• Study First Posted: 2023-09-28
• Status Verified: 2024-06
• Study Start: 2024-06-10
• Last Update Submitted: 2024-08-23
• Last Update Posted: 2024-08-27
• Primary Completion: 2026-05-31
• Study Completion: 2028-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Preterm birth at gestational age < 30 weeks or
2. Diagnosis of Congenital Diaphragmatic Hernia
3. Born at Amalia Children's Hospital or admitted 1rst day of life
4. Written informed consent of both parents or representatives

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Exclusion Criteria

1. Preterm infant born at gestational age ≥ 30 weeks
2. Perinatal Asphyxia; (Apgar score at 5' < 5 and first pH ≤ 7,0)
3. Major congenital anomalies or birth defects other than congenital diaphragmatic hernia;
4. Metabolic disease that necessitates a special diet other than human milk or formula feeding and or has a prognosis of impaired neurological development
5. Parental refusal of participation

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard care supplemented with HAPTOS intervention	HAPTOS (Handling Adapted to Postnatal age with Tactile-kinaesthetic and Oral sensorimotor Stimulation	Will receive standard of care according to the principles of developmental care which currently belongs to (inter-) national guidelines plus HAPTOS intervention which includes: tactile/ kinaesthetic massage of the trunk and extremities twice daily and stimulation of oral function by providing perioral stimulation up to 4 times a day. Interventions will be continued until clinical improvement.

Primary Outcome Measures

Name	Time	Method
Postmenstrual age at achievement of full oral feeding	52 weeks	Number of postmenstrual weeks until gastrointestinal tube is taken out
Number of days to achieve full enteral feeding	60 days	measuring the time from birth until enteral intake reaches 150ml/kg/d

Secondary Outcome Measures

Name	Time	Method
Use of laxatives	60 days	Number of laxatives given
Gastrointestinal Motility	100 days	Volume of gastric residuals per week
Periodic breathing	duration of hospitalization up to 15 months	Number of desaturations \< 80% and/or bradycardia \< 80/min that require intervention per week
Feeding difficulties	24 months	Number of infants with impaired oral motor skills
Maturation of heart rate variability	duration of intensive care stay up to 60 days	Number of infants with delayed regulation of the para- and sympathicus tonus measured continuously through monitordata collection
Growth at postmenstrual age	at 40 weeks, 3, 6, 12, 18 and 24 weeks	Gain in weight, length, and head circumference including percentiles
Neurocognitive development	at 24 months	Measuring cognitive and motor development using Bayley Scores of Infant Development (BSID III)
First meconium passage	14 days	Postnatal day at first meconium
Duration of meconium passage	14 days	Number of days until normal defecation
Vomiting	duration of hospitalization up to 15 months	Number of incidences of vomiting in combination with aspiration
Morbidity	100 days	Number of infants with necrotizing enterocolitis, spsis, chronic lung disease, retinopathy of prematurity, intra-ventricular hemorrhage
Parent participation in care	duration of hospitalization up to 100 days	Measuring number of parents who participate and frequency of activity
Duration hospital stay	100 days	Postnatal age at time of discharge home

Trial Locations

Locations (1)

Radboud University Nijmegen Medical Centre; 🇳🇱 Nijmegen, Netherlands