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

RecruitingNAAges any - 2 DaysAllRadboud University Medical Center
NCT06057415 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

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

1 site
Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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