Effect of Oral Enteral Nutrition in Pierre Robin Syndrome (NCT06303973) | Clinical Trial Compass
CompletedNot Applicable
Effect of Oral Enteral Nutrition in Pierre Robin Syndrome
Taiwan50 participantsStarted 2022-01-10
Plain-language 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 Feeding, n=23), all receiving systemic therapy. Before and after 4-week treatment, pulmonary infection, swallowing function, nutritional status and body weight between the two group were compared.
Who can participate
Age range1 Month – 12 Months
SexALL
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Inclusion Criteria:
* 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 Criteria:
* abnormalities in brain development or other neurological lesions.
* 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.
What they're measuring
1
Number of patients diagnosed as the pulmonary infection "Positive".