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Search / Trial NCT06328972

Intermittent Multifunctional Nutrition Tube in Cerebral Palsy and Dysphagia

Launched by COPKA SONPASHAN · Mar 18, 2024

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is studying two different ways to provide nutrition to infants with cerebral palsy who have difficulty swallowing (a condition known as dysphagia). The researchers want to see if using a specific type of feeding tube that is used intermittently (only when needed) is better than a traditional feeding tube that is used continuously. The trial will include 80 infants under one year old, and they will be split into two groups: one group will receive the intermittent feeding method, and the other group will continue with the standard continuous feeding method. Over a three-month period, the researchers will compare the infants' nutritional status, physical growth, swallowing ability, and the occurrence of pneumonia before and after the treatment.

To be eligible for this trial, infants must be diagnosed with cerebral palsy and have dysphagia confirmed through specific tests. They should also have a feeding tube already placed when they enter the study. However, infants with certain other medical conditions or serious health issues will not be included. Participants will receive close monitoring during the study, and their parents will be informed about what to expect throughout the trial. This study aims to find out which feeding method helps these infants grow and thrive better.

Gender

ALL

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.

About Copka Sonpashan

Copka Sonpashan is a leading clinical trial sponsor dedicated to advancing innovative therapeutic solutions through rigorous research and development. With a focus on enhancing patient care, the organization specializes in designing and executing clinical trials across various therapeutic areas, ensuring compliance with regulatory standards and ethical guidelines. By fostering collaboration with healthcare professionals and leveraging cutting-edge technologies, Copka Sonpashan aims to expedite the drug development process while maintaining a steadfast commitment to patient safety and scientific integrity.

Locations

Patients applied

0 patients applied

Trial Officials

Sumei Wang

Principal Investigator

Zhengzhou Tielu Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported