Improving Gastrointestinal Function In High-Risk Newborns By Stimulation Of The Enteric Nervous System
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HAPTOS (Handling Adapted to Postnatal age with Tactile-kinaesthetic and Oral sensorimotor Stimulation.
- Who it may be relevant to
- Registry conditions: Feeding and Eating Disorders. Basic parameters: up to 2 Days · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Procedure HAPTOS (Handling Adapted to Postnatal age with Tactile-kinaesthetic and Oral sensorimotor Stimulation
Tactile-kinaesthetic and Oral sensorimotor Stimulation
Primary outcome measures
- Number of days to achieve full enteral feeding [Time frame: 60 days]
- Postmenstrual age at achievement of full oral feeding [Time frame: 52 weeks]
Secondary outcome measures (12)
- First meconium passage [Time frame: 14 days]
- Duration of meconium passage [Time frame: 14 days]
- Use of laxatives [Time frame: 60 days]
- Gastrointestinal Motility [Time frame: 100 days]
- Vomiting [Time frame: duration of hospitalization up to 15 months]
- Periodic breathing [Time frame: duration of hospitalization up to 15 months]
- Feeding difficulties [Time frame: 24 months]
- Maturation of heart rate variability [Time frame: duration of intensive care stay up to 60 days]
- Growth at postmenstrual age [Time frame: at 40 weeks, 3, 6, 12, 18 and 24 weeks]
- Morbidity [Time frame: 100 days]
- Duration hospital stay [Time frame: 100 days]
- Neurocognitive development [Time frame: at 24 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Netherlands · 1 center
- Radboud University Nijmegen Medical Centre — Nijmegen
Identifiers
NCT: NCT06057415 · 114536