Comparing feeding methods for infants with Pierre Robin Syndrome
Effect of Oral Feeding in Infants With Pierre Robin Syndrome: A Randomized Controlled Study
This study is testing whether a new way of feeding infants with Pierre Robin Syndrome can help them eat better and stay healthier compared to a standard feeding method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 1 Month to 12 Months |
| Sex | All |
| Sponsor | People's Hospital of Zhengzhou University Academic / other |
| Locations | 1 site (Xinzhu) |
| Trial ID | NCT06267950 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of intermittent oro-esophageal tube feeding (IOE) versus nasogastric tube feeding (PNG) in infants diagnosed with Pierre Robin Syndrome (PRS) who experience dysphagia. Infants aged 1 to 12 months will be randomly assigned to either the IOE or PNG group, both receiving systemic therapy. The study will assess outcomes such as pulmonary infection rates, swallowing function, nutritional status, and body weight before and after a 4-week treatment period. The goal is to determine a safer and more effective nutritional support method for these infants.
Who should consider this trial
Good fit: Ideal candidates for this study are infants aged 1 to 12 months diagnosed with Pierre Robin Syndrome and experiencing dysphagia.
Not a fit: Patients with dysphagia caused by conditions other than Pierre Robin Syndrome or those with severe systemic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective feeding method for infants with Pierre Robin Syndrome, improving their nutritional status and overall health.
How similar studies have performed: While the approach of using intermittent oro-esophageal tube feeding is less common, similar studies exploring alternative feeding methods for dysphagic infants have shown promise, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * meeting the diagnostic criteria for Pierre Robin sequence based on CT and X-ray examinations, combined with clinical manifestations and physical signs. * with spontaneous vaginal birth, aged 1 to 12 months. * with dysphagia screened by the water drinking test and further confirmed by the assessment of Dysphagia Disorders Survey (DDS), Dysphagia Severity Scale (DSS), or Schedule for Oral Motor Assessment (SOMA) * before the treatment, the tube feeding was required and feasible after evaluation. * stable vital signs. * with nasogastric tubes placed before the treatment. * sufficient human milk could be provided by the mothers of the patients (with the help of a manual suction device). Exclusion Criteria: * abnormalities in brain development or other neurological lesions revealed by CT or MRI scans. * dysphagia caused by other diseases. * other congenital malformations, such as Down syndrome, cleft lip, and palate, etc. * severe systemic disease (such as severe infection, severe hepatic and renal dysfunction). * participants who need to receive other therapy which would potentially affect the result of this study
Where this trial is running
Xinzhu
- Hsinchu Rehabilitation Hospital — Xinzhu, Taiwan (Recruiting)
Study contacts
- Study coordinator: Qianyun Lu, Master
- Email: luqianyun@126.com
- Phone: 15333866454
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.