Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06057415

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

Up to 2 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radboud University Nijmegen Medical Centre

Nijmegen, 6500 HB, Netherlands

Location status: Recruiting

Location contact

M Nelissen, MSc

CONTACT

[email protected]

0031630368351

M Nelissen, MSc

SUB_INVESTIGATOR

V Christmann, dr.

CONTACT

[email protected]

0031243613936

V Christmann, dr.

PRINCIPAL_INVESTIGATOR

W P de Boode, prof.dr.

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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

Procedure

Tactile-kinaesthetic and Oral sensorimotor Stimulation

Primary outcomes

  1. Number of days to achieve full enteral feeding

    Time frame: 60 days

    measuring the time from birth until enteral intake reaches 150ml/kg/d

  2. Postmenstrual age at achievement of full oral feeding

    Time frame: 52 weeks

    Number of postmenstrual weeks until gastrointestinal tube is taken out

Secondary outcomes

  1. First meconium passage

    Time frame: 14 days

    Postnatal day at first meconium

  2. Duration of meconium passage

    Time frame: 14 days

    Number of days until normal defecation

  3. Use of laxatives

    Time frame: 60 days

    Number of laxatives given

  4. Gastrointestinal Motility

    Time frame: 100 days

    Volume of gastric residuals per week

  5. Vomiting

    Time frame: duration of hospitalization up to 15 months

    Number of incidences of vomiting in combination with aspiration

  6. Periodic breathing

    Time frame: duration of hospitalization up to 15 months

    Number of desaturations < 80% and/or bradycardia < 80/min that require intervention per week

  7. Feeding difficulties

    Time frame: 24 months

    Number of infants with impaired oral motor skills

  8. Maturation of heart rate variability

    Time frame: 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

  9. Growth at postmenstrual age

    Time frame: at 40 weeks, 3, 6, 12, 18 and 24 weeks

    Gain in weight, length, and head circumference including percentiles

  10. Morbidity

    Time frame: 100 days

    Number of infants with necrotizing enterocolitis, spsis, chronic lung disease, retinopathy of prematurity, intra-ventricular hemorrhage

  11. Duration hospital stay

    Time frame: 100 days

    Postnatal age at time of discharge home

  12. Neurocognitive development

    Time frame: at 24 months

    Measuring cognitive and motor development using Bayley Scores of Infant Development (BSID III)

  13. Parent participation in care

    Time frame: duration of hospitalization up to 100 days

    Measuring number of parents who participate and frequency of activity

Study contacts

Contact information is provided by the study sponsor or research team.

Viola Christmann, MD,PhD

CONTACT

[email protected]

Yvet Kroeze

CONTACT

[email protected]

+31 (0)24 36 55 700

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Nutricia Research

Registry information

Acronym: NeoHemoHapt

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Sep 28, 2023
Registry last updated
Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.