Clinical trial NCT06303934: Oral Enteral Nutrition in Infants With Cerebral Palsy and Dysphagia
Official title: Oral Versus Nasl Enteral Nutrition in Infants With Cerebral Palsy and Dysphagia: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: Ahmadu Bello University Teaching Hospital
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 80
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This was a randomized controlled study including 80 infants with cerebral palsy and dysphagia. The Participants were evenly divided into the observation group (with intermittent oro-esophageal tube feeding, n=40) and the control group (with persistent nasogastric tube feeding , n=40). Nutritional status and physical development, condition of dysphagia, and pneumonia before and after 3-month treatment were compared.

Detailed description: The efficacy of persistent nasogastric tube feeding is not sufficiently satisfactory, necessitating the exploration for a more effective and safe nutrition support approach. Therefore, this study reports the clinical effect of intermittent oro-esophageal tube feeding compared to persistent nasogastric tube feeding in the infants with cerebral palsy and dysphagia who received systemic therapy.

Method This was a randomized controlled study including 80 infants with cerebral palsy and dysphagia. The Participants were evenly divided into the observation group (with intermittent oro-esophageal tube feeding, n=40) and the control group (with persistent nasogastric tube feeding, n=40). Nutritional status and physical development, condition of dysphagia, and pneumonia before and after 3-month treatment were compared.

Eligibility criteria: Inclusion Criteria:

* meeting the diagnostic criteria of cerebral palsy.
* 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.

Primary outcomes:
measure: The Oral Motor Assessment Scale
timeFrame: day 1 and day 90
Secondary outcomes:
measure: Pneumonia
timeFrame: day 1 and day 90
measure: Hemoglobin
timeFrame: day 1 and day 90
measure: Total Protein
timeFrame: day 1 and day 90
measure: Albumin
timeFrame: day 1 and day 90
measure: Prealbumin
timeFrame: day 1 and day 90
measure: body weight
timeFrame: day 1 and day 90
measure: Penetration-Aspiration Scale
timeFrame: day 1 and day 90
measure: Functional Oral Intake Scale for Infants
timeFrame: day 1 and day 90
measure: Feeding amount
timeFrame: day 1 and day 90
Other outcomes:
Locations:
city: Pingdong
country: Taiwan
facility: River First Hos.
Study officials:
affiliation: Site Coordinator of United Medical Group
name: Nieto Luis, Master
role: STUDY_CHAIR
References: