NCT06057415 Improving Gastrointestinal Function In High-Risk Newborns By Stimulation Of The Enteric Nervous System
| NCT ID | NCT06057415 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Radboud University Medical Center |
| Condition | Feeding and Eating Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-06-10 |
| Primary Completion | 2026-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2024-06-10 with a primary completion date of 2026-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Viola Christmann, MD, PhD
PRINCIPAL INVESTIGATOR
Radboud University Medical Center
Frequently Asked Questions
Who can join the NCT06057415 clinical trial?
This trial is open to participants of all sexes, up to 2 Days, studying Feeding and Eating Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06057415 currently recruiting?
Yes, NCT06057415 is actively recruiting participants. Contact the research team at pediatricresearchunit@radboudumc.nl for enrollment information.
Where is the NCT06057415 trial being conducted?
This trial is being conducted at Nijmegen, Netherlands.
Who is sponsoring the NCT06057415 clinical trial?
NCT06057415 is sponsored by Radboud University Medical Center. The principal investigator is Viola Christmann, MD, PhD at Radboud University Medical Center. The trial plans to enroll 200 participants.