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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Feeding and Eating Disorders
• Intervention / Treatment: Procedure: HAPTOS (Handling Adapted to Postnatal age with Tactile-kinaesthetic and Oral sensorimotor Stimulation

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 Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Viola Christmann, MD,PhD; Email: viola.christmann@radboudumc.nl
• Study Contact Backup: Name: Yvet Kroeze; Phone Number: +31 (0)24 36 55 700; Email: pediatricresearchunit@radboudumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard care; Will receive standard of care according to the institutional protocol and principles of developmental care which currently belongs to (inter-) national guidelines and is regarded as safe.
Experimental: Standard care supplemented with HAPTOS intervention; 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.	Procedure: HAPTOS (Handling Adapted to Postnatal age with Tactile-kinaesthetic and Oral sensorimotor Stimulation; Tactile-kinaesthetic and Oral sensorimotor Stimulation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Collaborators: Nutricia Research
• Investigators: Principal Investigator: Viola Christmann, MD, PhD, Radboud University Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2028

Study Registration Dates

• First Submitted: June 21, 2023
• First Submitted That Met QC Criteria: September 21, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Estimated): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: preterm infants; congenital diaphragmatic hernia; tactile stimulation; autonomous nervous system; high-risk newborns
• Additional Relevant MeSH Terms: Mental Disorders; Feeding and Eating Disorders
• Other Study ID Numbers: 114536

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No