Status:
RECRUITING
Improving Gastrointestinal Function In High-Risk Newborns By Stimulation Of The Enteric Nervous System
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
Nutricia Research
Conditions:
Feeding and Eating Disorders
Eligibility:
All Genders
Up to 2 years
Phase:
NA
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...
Detailed Description
Infants born preterm or with congenital diaphragmatic hernia (CDH) are at risk for several long-term unfavourable outcomes that can be related to feeding difficulties from birth onwards. Adverse nutri...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2028
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06057415
Start Date
June 10 2024
End Date
May 31 2028
Last Update
August 27 2024
Active Locations (1)
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1
Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands, 6500 HB