Intermittent Oro-Esophageal Tube Feeding vs. Nasogastric Tube Feeding in Infants With Pierre Robin Syndrome

Not Applicable

Terminated

• Conditions: Dysphagia; Pierre-Robin Syndrome
• Interventions: Behavioral: systematic therapy; Device: IOE; Device: PNG

• Registration Number: NCT06178562
• Lead Sponsor: Zeng Changhao

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.

Study Timeline

• Study Start: 2022-01-15
• Primary Completion: 2023-06-01
• Study Completion: 2023-06-30
• Study First Submitted: 2023-12-12
• Study First Submitted QC: 2023-12-20
• Study First Posted: 2023-12-21
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-02
• Last Update Posted: 2024-03-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IOE group	IOE	IOE groups were given systematic therapy according to the routine treatment plan for PRS for 4 weeks. The main intervention measures included: 1) non-invasive ventilator treatment, generally at least once every night and typically not exceeding continuous daily usage.; 2) attention to feeding and sleeping positions, with a recommended sleeping position of lateral recumbent and the head of the bed raised by 20-30°; 3) swallowing function training, such as tongue muscle stretching training, assisted anterior jaw protrusion training, lemon ice stimulation to the soft palate, pharyngeal wall, etc., generally 5 days per week, twice per day, 5-20 minutes each time; 4) pulmonary ultrashort wave therapy, generally at least 2-3 times a week, and not more than once a day; 5) physical therapy, such as intensive training for gross motor functions including lifting the head, turning over, sitting, crawling, standing, etc., generally 3-5 days per week, 1-2 times per day, 5-20 min each time.
IOE group	systematic therapy	IOE groups were given systematic therapy according to the routine treatment plan for PRS for 4 weeks. The main intervention measures included: 1) non-invasive ventilator treatment, generally at least once every night and typically not exceeding continuous daily usage.; 2) attention to feeding and sleeping positions, with a recommended sleeping position of lateral recumbent and the head of the bed raised by 20-30°; 3) swallowing function training, such as tongue muscle stretching training, assisted anterior jaw protrusion training, lemon ice stimulation to the soft palate, pharyngeal wall, etc., generally 5 days per week, twice per day, 5-20 minutes each time; 4) pulmonary ultrashort wave therapy, generally at least 2-3 times a week, and not more than once a day; 5) physical therapy, such as intensive training for gross motor functions including lifting the head, turning over, sitting, crawling, standing, etc., generally 3-5 days per week, 1-2 times per day, 5-20 min each time.
PNG group	systematic therapy	PNG groups were given systematic therapy according to the routine treatment plan for PRS for 4 weeks. The main intervention measures included: 1) non-invasive ventilator treatment, generally at least once every night and typically not exceeding continuous daily usage.; 2) attention to feeding and sleeping positions, with a recommended sleeping position of lateral recumbent and the head of the bed raised by 20-30°; 3) swallowing function training, such as tongue muscle stretching training, assisted anterior jaw protrusion training, lemon ice stimulation to the soft palate, pharyngeal wall, etc., generally 5 days per week, twice per day, 5-20 minutes each time; 4) pulmonary ultrashort wave therapy, generally at least 2-3 times a week, and not more than once a day; 5) physical therapy, such as intensive training for gross motor functions including lifting the head, turning over, sitting, crawling, standing, etc., generally 3-5 days per week, 1-2 times per day, 5-20 min each time.
PNG group	PNG	PNG groups were given systematic therapy according to the routine treatment plan for PRS for 4 weeks. The main intervention measures included: 1) non-invasive ventilator treatment, generally at least once every night and typically not exceeding continuous daily usage.; 2) attention to feeding and sleeping positions, with a recommended sleeping position of lateral recumbent and the head of the bed raised by 20-30°; 3) swallowing function training, such as tongue muscle stretching training, assisted anterior jaw protrusion training, lemon ice stimulation to the soft palate, pharyngeal wall, etc., generally 5 days per week, twice per day, 5-20 minutes each time; 4) pulmonary ultrashort wave therapy, generally at least 2-3 times a week, and not more than once a day; 5) physical therapy, such as intensive training for gross motor functions including lifting the head, turning over, sitting, crawling, standing, etc., generally 3-5 days per week, 1-2 times per day, 5-20 min each time.

Primary Outcome Measures

Name	Time	Method
Number of patients diagnosed as the pulmonary infection "Positive".	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 Outcome Measures

Name	Time	Method
Nutritional status-hemoglobin	Day 1 and Day 28	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.
Nutritional status-prealbumin	Day 1 and Day 28	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.
Nutritional status-total protein	Day 1 and Day 28	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.
Nutritional status-albumin	Day 1 and Day 28	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.
Swallowing function	Day 1 and Day 28	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.
Body weight	Day 1 and Day 28	Body weight measurement of the infants was conducted by the same nurse according to the relevant standards.

Trial Locations

Locations (1)

Zheng da yi fu yuan Hospital; 🇨🇳 Zhengzhou, China