Clinical trial NCT06185504: Comparison of Intermittent Oro-Esophageal Tube Feeding in Infants With Cerebral Palsy and Dysphagia
Official title: Comparison of Intermittent Oro-Esophageal Tube Feeding Versus Persistent Nasogastric Tube Feeding in Infants With Cerebral Palsy and Dysphagia: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: People's Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2023-12-29
Enrollment: 80
Sex: ALL
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: In China, for nutrition support in the infants under one year of age with cerebral palsy and dysphagia, persistent nasogastric tube feeding is the mainstream choice. However, 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 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.

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: upper arm circumference
timeFrame: day 1 and day 90
measure: Penetration-Aspiration Scale
timeFrame: day 1 and day 90
measure: The Functional Oral Intake Scale for Infants
timeFrame: day 1 and day 90
measure: Feeding amount
timeFrame: day 1, day 11, day 21, day 31, day 41, day 51, day 61, day 71, day 81 and day 90
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Zheng da yi fu yuan hospital
state: Henan
Study officials:
affiliation: Site Coordinator of United Medical Group located in Miami
name: Nieto Luis
role: STUDY_CHAIR
References:
citation: Novak I, Morgan C, Fahey M, Finch-Edmondson M, Galea C, Hines A, Langdon K, Namara MM, Paton MC, Popat H, Shore B, Khamis A, Stanton E, Finemore OP, Tricks A, Te Velde A, Dark L, Morton N, Badawi N. State of the Evidence Traffic Lights 2019: Systematic Review of Interventions for Preventing and Treating Children with Cerebral Palsy. Curr Neurol Neurosci Rep. 2020 Feb 21;20(2):3. doi: 10.1007/s11910-020-1022-z.
citation: Jiang H, Li X, Jin C, Wang M, Liu C, Chan KC, Yang J. Early Diagnosis of Spastic Cerebral Palsy in Infants with Periventricular White Matter Injury Using Diffusion Tensor Imaging. AJNR Am J Neuroradiol. 2019 Jan;40(1):162-168. doi: 10.3174/ajnr.A5914. Epub 2018 Dec 13.