An interventional study of HAPTOS (Handling Adapted to Postnatal age with Tactile-kinaesthetic and Oral sensorimotor Stimulation in Feeding and Eating Disorders, sponsored by Radboud University Medical Center. Recruiting at 1 site in Netherlands. Open to participants aged Up to 2 Days. Per ClinicalTrials.gov, last updated 2024-08-27.
Sponsored by Radboud University Medical Center · Not applicable, Interventional, and Treatment
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:
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.
740 studies on the registry are indexed under Feeding and Eating Disorders; 159 are open to participants now.
This study's planned enrollment of 200 is above the median of 75 across 540 interventional studies indexed under Feeding and Eating Disorders.
Browse Feeding and Eating Disorders studies →Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
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.
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
Number of days to achieve full enteral feeding
measuring the time from birth until enteral intake reaches 150ml/kg/d
Time frame: 60 days
Postmenstrual age at achievement of full oral feeding
Number of postmenstrual weeks until gastrointestinal tube is taken out
Time frame: 52 weeks
First meconium passage
Postnatal day at first meconium
Time frame: 14 days
Duration of meconium passage
Number of days until normal defecation
Time frame: 14 days
Use of laxatives
Number of laxatives given
Time frame: 60 days
Gastrointestinal Motility
Volume of gastric residuals per week
Time frame: 100 days
Vomiting
Number of incidences of vomiting in combination with aspiration
Time frame: duration of hospitalization up to 15 months
Periodic breathing
Number of desaturations \< 80% and/or bradycardia \< 80/min that require intervention per week
Time frame: duration of hospitalization up to 15 months
Feeding difficulties
Number of infants with impaired oral motor skills
Time frame: 24 months
Maturation of heart rate variability
Number of infants with delayed regulation of the para- and sympathicus tonus measured continuously through monitordata collection
Time frame: duration of intensive care stay up to 60 days
Growth at postmenstrual age
Gain in weight, length, and head circumference including percentiles
Time frame: 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
Time frame: 100 days
Duration hospital stay
Postnatal age at time of discharge home
Time frame: 100 days
Neurocognitive development
Measuring cognitive and motor development using Bayley Scores of Infant Development (BSID III)
Time frame: at 24 months
Parent participation in care
Measuring number of parents who participate and frequency of activity
Time frame: duration of hospitalization up to 100 days
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