Effect of Oral Feeding in Infants With Pierre Robin Syndrome

Z

Zeng Changhao

Status

Enrolling

Conditions

Pierre Robin Syndrome

Treatments

Device: gastric tube feeding
Device: intermittent oro-esophageal tube feeding
Behavioral: systematic therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT06267950
PILUO-INFANT

Details and patient eligibility

About

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.

Full 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) and the PNG group (with PNG), 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.

Enrollment

60 estimated patients

Sex

All

Ages

1 to 12 months old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups

IOE group
Experimental group
Description:
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.
Treatment:
Behavioral: systematic therapy
Device: intermittent oro-esophageal tube feeding
PNG group
Active Comparator group
Description:
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.
Treatment:
Behavioral: systematic therapy
Device: gastric tube feeding

Trial contacts and locations

1

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Central trial contact

Weiji Zhao, Master; Qianyun Lu, Master

Data sourced from clinicaltrials.gov

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