Status:
TERMINATED
Intermittent Oro-Esophageal Tube Feeding vs. Nasogastric Tube Feeding in Infants With Pierre Robin Syndrome
Lead Sponsor:
Zeng Changhao
Conditions:
Pierre-Robin Syndrome
Dysphagia
Eligibility:
All Genders
1-12 years
Phase:
NA
Brief Summary
This was a randomized controlled study. The infants enrolled were randomly divided into the IOE group (with Intermittent Oro-Esophageal Tube Feeding, n=25) and the PNG group (with Nasogastric Tube Fee...
Detailed Description
Pierre Robin Syndrome (PRS) can cause dysphagia. In China, persistent nasogastric tube feeding (PNG) is the mainstream choice as nutrition support in the dysphagic infants with PRS. However, PNG is as...
Eligibility Criteria
Inclusion
- meeting the diagnostic criteria for Pierre Robin sequence based on CT and X-ray examinations, combined with clinical manifestations and physical signs.
- with spontaneous vaginal birth, aged 1 to 12 months.
- with dysphagia screened by the water drinking test and further confirmed by the assessment of Dysphagia Disorders Survey (DDS), Dysphagia Severity Scale (DSS), or Schedule for Oral Motor Assessment (SOMA)
- before the treatment, the tube feeding was required and feasible after evaluation.
- stable vital signs.
- with nasogastric tubes placed before the treatment.
- sufficient human milk could be provided by the mothers of the patients (with the help of a manual suction device).
Exclusion
- abnormalities in brain development or other neurological lesions revealed by CT or MRI scans.
- dysphagia caused by other diseases.
- other congenital malformations, such as Down syndrome, cleft lip, and palate, etc.
- severe systemic disease (such as severe infection, severe hepatic and renal dysfunction).
- participants who need to receive other therapy which would potentially affect the result of this study.
Key Trial Info
Start Date :
January 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06178562
Start Date
January 15 2022
End Date
June 30 2023
Last Update
March 5 2024
Active Locations (1)
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1
Zheng da yi fu yuan Hospital
Zhengzhou, China