Improving gut function in high-risk newborns through sensory stimulation
Improving Gastrointestinal Function In High-Risk Newborns By Stimulation Of The Enteric Nervous System
This study is testing if a special sensory stimulation method can help preterm babies and those with a specific birth defect eat better and faster than those who only get regular care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | N/A to 2 Days |
| Sex | All |
| Sponsor | Radboud University Medical Center Academic / other |
| Locations | 1 site (Nijmegen) |
| Trial ID | NCT06057415 on ClinicalTrials.gov |
What this trial studies
This intervention aims to assess the effectiveness of the HAPTOS method, which involves tactile-kinesthetic and oral sensorimotor stimulation, in enhancing gastrointestinal function in preterm infants born before 30 weeks of gestation and those with congenital diaphragmatic hernia. The study will compare outcomes between infants receiving standard care plus the HAPTOS intervention and those receiving only standard care. The primary focus is on the time taken to achieve full enteral and oral feeding, which is critical for the health and development of these vulnerable infants.
Who should consider this trial
Good fit: Ideal candidates include preterm infants born before 30 weeks of gestation or newborns diagnosed with congenital diaphragmatic hernia.
Not a fit: Patients who are preterm infants born at 30 weeks or later, or those with significant perinatal complications or congenital anomalies, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved feeding outcomes and overall health for high-risk newborns.
How similar studies have performed: While the specific HAPTOS intervention is novel, similar sensory stimulation approaches have shown promise in improving outcomes in preterm infants.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Preterm birth at gestational age \< 30 weeks or 2. Diagnosis of Congenital Diaphragmatic Hernia 3. Born at Amalia Children's Hospital or admitted 1rst day of life 4. Written informed consent of both parents or representatives Exclusion Criteria: 1. Preterm infant born at gestational age ≥ 30 weeks 2. Perinatal Asphyxia; (Apgar score at 5' \< 5 and first pH ≤ 7,0) 3. Major congenital anomalies or birth defects other than congenital diaphragmatic hernia; 4. Metabolic disease that necessitates a special diet other than human milk or formula feeding and or has a prognosis of impaired neurological development 5. Parental refusal of participation
Where this trial is running
Nijmegen
- Radboud University Nijmegen Medical Centre — Nijmegen, Netherlands (Recruiting)
Study contacts
- Principal investigator: Viola Christmann, MD, PhD — Radboud University Medical Center
- Study coordinator: Yvet Kroeze
- Email: pediatricresearchunit@radboudumc.nl
- Phone: +31 (0)24 36 55 700
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.