Dysphagia Clinical Trial
— PRSOfficial title:
Improving Clinical Outcomes in Infants With Pierre Robin Syndrome: A Randomized Controlled Study of Intermittent Oro-Esophageal Tube Feeding vs. Nasogastric Tube Feeding
Verified date | March 2024 |
Source | People's Hospital of Zhengzhou University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 50 |
Est. completion date | June 30, 2023 |
Est. primary completion date | June 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Month to 12 Months |
Eligibility | 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 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. |
Country | Name | City | State |
---|---|---|---|
China | Zheng da yi fu yuan Hospital | Zhengzhou |
Lead Sponsor | Collaborator |
---|---|
Zeng Changhao |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients diagnosed as the pulmonary infection "Positive". | Once the symptoms of respiratory tract infection such as fever, cough, sputum, dyspnea, and respiratory distress were observed, the medical staffs would conduct the future exam. With the presence of rales on auscultation of both lungs, examination by CT, the routine blood test, and blood culture, the patients would be diagnosed as the pulmonary infection "Positive". | Day 1 and Day 28 | |
Secondary | Nutritional status-total protein | The relevant indicators include total protein (TP, g/L) from the blood test within 24h after admission and the last day of treatment, generally, with empty-stomach infants and in the morning. | Day 1 and Day 28 | |
Secondary | Nutritional status-hemoglobin | The relevant indicators include hemoglobin (Hb, g/L)from the blood test within 24h after admission and the last day of treatment, generally, with empty-stomach infants and in the morning. | Day 1 and Day 28 | |
Secondary | Nutritional status-albumin | The relevant indicators include albumin (ALB, g/L)from the blood test within 24h after admission and the last day of treatment, generally, with empty-stomach infants and in the morning. | Day 1 and Day 28 | |
Secondary | Nutritional status-prealbumin | The relevant indicators include prealbumin (PA, mg/L) from the blood test within 24h after admission and the last day of treatment, generally, with empty-stomach infants and in the morning. | Day 1 and Day 28 | |
Secondary | Body weight | Body weight measurement of the infants was conducted by the same nurse according to the relevant standards. | Day 1 and Day 28 | |
Secondary | Swallowing function | The water drinking test (WDT) was used to assess the swallowing function due to the low feasibility of using swallowing imaging or flexible laryngoscopy in the infants with PRS and that these patients were unable to communicate and cooperate to complete the subjective components of most questionnaires. The patients were required to sit and drink 30 mL of warm water. Based on the completion of water intake and the occurrence of coughing, the results were divided into levels 1 to 6, with higher levels indicating a more severe degree of dysphagia. | Day 1 and Day 28 |
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