Clinical trial NCT06267950: Effect of Oral Feeding in Infants With Pierre Robin Syndrome
Official title: Effect of Oral Feeding in Infants With Pierre Robin Syndrome: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pierre Robin Syndrome
Lead sponsor: People's Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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) 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.

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 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

Primary outcomes:
measure: Number of patients diagnosed as the pulmonary infection "Positive"
timeFrame: Day 1 and Day 28
Secondary outcomes:
measure: Nutritional status-total protein
timeFrame: Day 1 and Day 28
measure: Nutritional status-hemoglobin
timeFrame: Day 1 and Day 28
measure: Nutritional status-albumin
timeFrame: Day 1 and Day 28
measure: Body weight
timeFrame: Day 1 and Day 28
measure: The Functional Oral Intake Scale for Infants
timeFrame: Day 1 and Day 28
Other outcomes:
Locations:
city: Xinzhu
country: Taiwan
facility: Hsinchu Rehabilitation Hospital
Study officials:
affiliation: Site Coordinator of United Medical Group
name: Nieto Luis, Master
role: STUDY_DIRECTOR
References: