Intermittent Multifunctional Nutrition Tube in Cerebral Palsy and Dysphagia

Last updated: March 2, 2024
Sponsor: Zeng Changhao
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cerebral Palsy

Treatment

systemic therapy

Persistent Nasogastric Tube Feeding

Intermittent Oro-Esophageal Tube Feeding

Clinical Study ID

NCT06269835
NAOTAN-IOE
  • Ages 6-12
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • meeting the diagnostic criteria of cerebral palsy formulated by the 13th NationalConference on Pediatric Cerebral Palsy Rehabilitation;
  • age<1 year;
  • diagnosed as dysphagia confirmed by Dysphagia Disorder Survey or pediatricesophagoscopy;
  • with a nasogastric tube inserted at admission;
  • enteral nutrition support is required and feasible.

Exclusion

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, orother acute and severe symptoms;
  • with abnormalities in the oral cavity, pharynx, esophagus, or other parts of thedigestive tract;
  • with poor compliance.

Study Design

Total Participants: 100
Treatment Group(s): 3
Primary Treatment: systemic therapy
Phase:
Study Start date:
February 28, 2024
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan 450001
    China

    Site Not Available

  • Maternal and Child Health Hospital of Henan Province

    Zhengzhou, Henan 450000
    China

    Active - Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan 450001
    China

    Site Not Available

  • Center Rehabilitation Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

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