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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06057415
Other study ID # 114536
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 1, 2024
Est. completion date May 31, 2028

Study information

Verified date June 2023
Source Radboud University Medical Center
Contact Yvet Kroeze
Phone +31 (0)24 36 55 700
Email pediatricresearchunit@radboudumc.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date May 31, 2028
Est. primary completion date May 31, 2026
Accepts healthy volunteers No
Gender All
Age group N/A to 2 Days
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Radboud University Medical Center Nutricia Research

Outcome

Type Measure Description Time frame Safety issue
Primary Number of days to achieve full enteral feeding measuring the time from birth until enteral intake reaches 150ml/kg/d 60 days
Primary Postmenstrual age at achievement of full oral feeding Number of postmenstrual weeks until gastrointestinal tube is taken out 52 weeks
Secondary First meconium passage Postnatal day at first meconium 14 days
Secondary Duration of meconium passage Number of days until normal defecation 14 days
Secondary Use of laxatives Number of laxatives given 60 days
Secondary Gastrointestinal Motility Volume of gastric residuals per week 100 days
Secondary Vomiting Number of incidences of vomiting in combination with aspiration duration of hospitalization up to 15 months
Secondary Periodic breathing Number of desaturations < 80% and/or bradycardia < 80/min that require intervention per week duration of hospitalization up to 15 months
Secondary Feeding difficulties Number of infants with impaired oral motor skills 24 months
Secondary 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
Secondary Growth at postmenstrual age Gain in weight, length, and head circumference including percentiles at 40 weeks, 3, 6, 12, 18 and 24 weeks
Secondary Morbidity Number of infants with necrotizing enterocolitis, spsis, chronic lung disease, retinopathy of prematurity, intra-ventricular hemorrhage 100 days
Secondary Duration hospital stay Postnatal age at time of discharge home 100 days
Secondary Neurocognitive development Measuring cognitive and motor development using Bayley Scores of Infant Development (BSID III) at 24 months
Secondary Parent participation in care Measuring number of parents who participate and frequency of activity duration of hospitalization up to 100 days
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