Feeding method comparison for infants with cerebral palsy and dysphagia
Intermittent Multifunctional Nutrition Tube Versus Persistent Nasogastric Tube Feeding in Infants With Cerebral Palsy and Dysphagia: A Randomized Controlled Study
This study tests whether a new way of feeding infants with cerebral palsy and swallowing difficulties can help them grow better and stay healthier compared to a standard feeding method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 6 Months to 12 Months |
| Sex | All |
| Sponsor | People's Hospital of Zhengzhou University Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06269835 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of intermittent oro-esophageal tube feeding versus persistent nasogastric tube feeding in infants under one year of age diagnosed with cerebral palsy and dysphagia. A total of 80 participants are randomly assigned to either the observation group receiving intermittent feeding or the control group receiving persistent feeding. The study aims to evaluate nutritional status, physical development, dysphagia condition, and incidence of pneumonia over a three-month treatment period. This approach seeks to identify a safer and more effective nutritional support method for these vulnerable infants.
Who should consider this trial
Good fit: Ideal candidates for this study are infants under one year of age diagnosed with cerebral palsy and dysphagia requiring enteral nutrition support.
Not a fit: Patients with dysphagia caused by other diseases, progressive neurological conditions, or severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective feeding method that improves nutritional outcomes and overall health for infants with cerebral palsy and dysphagia.
How similar studies have performed: While the approach of intermittent feeding is being explored, the efficacy of this specific method compared to persistent feeding in this population is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * meeting the diagnostic criteria of cerebral palsy formulated by the 13th National Conference on Pediatric Cerebral Palsy Rehabilitation; * age\<1 year; * diagnosed as dysphagia confirmed by Dysphagia Disorder Survey or pediatric esophagoscopy; * with a nasogastric tube inserted at admission; * enteral nutrition support is required and feasible. Exclusion Criteria: * with dysphagia caused by other diseases or factors; * with progressive neurological disease or degenerative neurological disease; * with severe heart disease, liver or kidney dysfunction, hematological disorders, or other acute and severe symptoms; * with abnormalities in the oral cavity, pharynx, esophagus, or other parts of the digestive tract; * with poor compliance.
Where this trial is running
Seoul
- Center Rehabilitation Hospital — Seoul, Korea, Republic of (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.