Actively Recruiting
Improving Gastrointestinal Function In High-Risk Newborns By Stimulation Of The Enteric Nervous System
Led by Radboud University Medical Center · Updated on 2024-08-27
200
Participants Needed
1
Research Sites
207 weeks
Total Duration
On this page
Sponsors
R
Radboud University Medical Center
Lead Sponsor
N
Nutricia Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Improving Gastrointestinal Function In High-Risk Newborns By Stimulation Of The Enteric Nervous System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Preterm birth at gestational age less than 30 weeks or
- Diagnosis of Congenital Diaphragmatic Hernia
- Born at Amalia Children's Hospital or admitted on first day of life
- Written informed consent of both parents or representatives
You will not qualify if you...
- Preterm infant born at gestational age 30 weeks or more
- Perinatal asphyxia (Apgar score at 5 minutes less than 5 and first pH 7.0 or less)
- Major congenital anomalies or birth defects other than congenital diaphragmatic hernia
- Metabolic disease requiring a special diet other than human milk or formula feeding or with a prognosis of impaired neurological development
- Parental refusal of participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands, 6500 HB
Actively Recruiting
Research Team
Y
Yvet Kroeze
CONTACT
V
Viola Christmann, MD,PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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