Improving Gastrointestinal Function In High-Risk Newborns By Stimulation Of The Enteric Nervous System
- Conditions
- Feeding and Eating Disorders
- Registration Number
- NCT06057415
- Lead Sponsor
- Radboud University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria:<br><br> 1. Preterm birth at gestational age < 30 weeks or<br><br> 2. Diagnosis of Congenital Diaphragmatic Hernia<br><br> 3. Born at Amalia Children's Hospital or admitted 1rst day of life<br><br> 4. Written informed consent of both parents or representatives<br><br>Exclusion Criteria:<br><br> 1. Preterm infant born at gestational age = 30 weeks<br><br> 2. Perinatal Asphyxia; (Apgar score at 5' < 5 and first pH = 7,0)<br><br> 3. Major congenital anomalies or birth defects other than congenital diaphragmatic<br> hernia;<br><br> 4. Metabolic disease that necessitates a special diet other than human milk or formula<br> feeding and or has a prognosis of impaired neurological development<br><br> 5. Parental refusal of participation
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of days to achieve full enteral feeding;Postmenstrual age at achievement of full oral feeding
- Secondary Outcome Measures
Name Time Method First meconium passage;Duration of meconium passage;Use of laxatives;Gastrointestinal Motility;Vomiting;Periodic breathing;Feeding difficulties;Maturation of heart rate variability;Growth at postmenstrual age;Morbidity;Duration hospital stay;Neurocognitive development;Parent participation in care