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

NCT ID: NCT06057415

Last Updated: 2024-08-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-10
• Study Completion Date: 2028-05-31

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.

Conditions

Feeding and Eating Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

HAPTOS (Handling Adapted to Postnatal age with Tactile-kinaesthetic and Oral sensorimotor Stimulation

Intervention Type: PROCEDURE

Tactile-kinaesthetic and Oral sensorimotor Stimulation

Interventions

HAPTOS (Handling Adapted to Postnatal age with Tactile-kinaesthetic and Oral sensorimotor Stimulation

Tactile-kinaesthetic and Oral sensorimotor Stimulation

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Maximum Eligible Age: 2 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nutricia Research

INDUSTRY

Sponsor Role: collaborator

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Viola Christmann, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

Radboud University Nijmegen Medical Centre

Nijmegen, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Yvet Kroeze

Role: CONTACT

pediatricresearchunit@radboudumc.nl

+31 (0)24 36 55 700

Viola Christmann, MD,PhD

Role: CONTACT

viola.christmann@radboudumc.nl

Facility Contacts

V Christmann, dr.

Role: primary

v.christmann@radboudumc.nl

0031243613936

M Nelissen, MSc

Role: backup

m.nelissen@radboudumc.nl

0031630368351

Other Identifiers

114536

Identifier Type: -

Identifier Source: org_study_id