Effect of Oral Feeding in Infants With Pierre Robin Syndrome

Launched by ZENG CHANGHAO · Feb 12, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating how different feeding methods affect infants with Pierre Robin Syndrome, a condition that can make it difficult for them to swallow and breathe properly. The study compares two types of feeding: one group of infants will receive food through a special tube placed in their mouth and down their throat (Intermittent Oro-Esophageal Tube Feeding), while the other group will be fed through a tube placed in their nose (Nasogastric Tube Feeding). The researchers will look at factors like lung infections, swallowing ability, nutrition, and weight before and after four weeks of treatment.

To be eligible for this trial, infants should be between 1 and 12 months old, have been born through a spontaneous vaginal delivery, and have been diagnosed with Pierre Robin Syndrome. They must also have swallowing difficulties confirmed through specific tests and have stable vital signs. Participants will receive care and feeding methods as part of the study, and mothers will need to be able to provide enough breast milk. It's important to note that infants with certain neurological issues or other serious health problems will not be included in this trial.

Gender

ALL

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