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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 2
SponsorRadboud University Medical Center

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

200 Participants
are divided into 2 treatment groups

Sponsors and collaborators