Effect of Oral Feeding in Infants With Pierre Robin Syndrome: A Randomized Controlled Study

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This was a randomized controlled study. The infants enrolled were randomly divided into the IOE group (with Intermittent Oro-Esophageal Tube Feeding) and the PNG group (with Nasogastric Tube Feeding), 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 month
Maximum Age: 1
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Taiwan
Hsinchu Rehabilitation Hospital
RECRUITING
Xinzhu
Contact Information
Primary
Qianyun Lu, Master
luqianyun@126.com
15333866454
Backup
Weiji Zhao, Master
zwjww2009@163.com
17839973473
Time Frame
Start Date: 2024-02-29
Estimated Completion Date: 2024-10
Participants
Target number of participants: 60
Treatments
Experimental: IOE group
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.
Active_comparator: PNG group
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.
Related Therapeutic Areas
Sponsors
Leads: Zeng Changhao

This content was sourced from clinicaltrials.gov

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