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

Recruiting now · Not applicable

Conditions studied: Feeding and Eating Disorders

In brief

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.

Key facts

Study ID

NCT06057415

Run by

Radboud University Medical Center

People needed

200

Starts

2024-06-10

Expected to finish

2028-05-31

Last updated by the study team

2024-08-27

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Radboud University Nijmegen Medical Centre — Nijmegen, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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