Effect of Oral Versus Nasal Enteral Nutrition in Pierre Robin Syndrome: A Randomized Controlled Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pierre Robin Syndrome
- Sponsor
- Muhammad
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Number of patients diagnosed as the pulmonary infection "Positive".
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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 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.
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 associated with various complications, necessitating the exploration for a safer and more effective nutritional support approach. Therefore, this study aims to observe the clinical effect of intermittent oro-esophageal tube feeding (IOE) compared to PNG in the dysphagic infants with PRS who received systemic therapy. This was a randomized controlled study. The infants enrolled were randomly divided into the IOE group (with IOE, n=25) and the PNG group (with PNG, 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.
Investigators
Muhammad
Research Director
Ahmadu Bello University Teaching Hospital
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Number of patients diagnosed as the pulmonary infection "Positive".
Time Frame: Day 1 and Day 28
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".
Secondary Outcomes
- Body weight(Day 1 and Day 28)
- Nutritional status-albumin(Day 1 and Day 28)
- Nutritional status-total protein(Day 1 and Day 28)
- Nutritional status-hemoglobin(Day 1 and Day 28)
- Swallowing function(Day 1 and Day 28)
- Nutritional status-prealbumin(Day 1 and Day 28)