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Search / Trial NCT06328959

Effect of Oral Feeding in Infants With Pierre Robin Syndrome

Launched by COPKA SONPASHAN · Mar 18, 2024

Trial Information

Current as of July 09, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at how two different types of feeding methods affect infants with Pierre Robin Syndrome, a condition that can make it difficult for babies to swallow and breathe properly. The study will compare two groups of infants: one group will receive feeding through a special tube that goes into their mouth and throat (Intermittent Oro-Esophageal Tube Feeding), while the other group will receive feeding through a tube placed in their nose (Nasogastric Tube Feeding). Researchers will check how well the babies are swallowing, their nutritional status, body weight, and whether they develop any lung infections over a period of four weeks.

To be eligible for this trial, infants must be between 1 and 12 months old, have been diagnosed with Pierre Robin Syndrome, and have difficulty swallowing (dysphagia). They should also have stable vital signs and be able to receive tube feeding. However, infants with certain brain abnormalities, other congenital conditions, or severe health issues will not be included. This trial is not yet recruiting participants, but it aims to better understand the best feeding options for these infants, which could help improve their overall health and well-being.

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.
  • 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

About Copka Sonpashan

Copka Sonpashan is a leading clinical trial sponsor dedicated to advancing innovative therapeutic solutions through rigorous research and development. With a focus on enhancing patient care, the organization specializes in designing and executing clinical trials across various therapeutic areas, ensuring compliance with regulatory standards and ethical guidelines. By fostering collaboration with healthcare professionals and leveraging cutting-edge technologies, Copka Sonpashan aims to expedite the drug development process while maintaining a steadfast commitment to patient safety and scientific integrity.

Locations

Patients applied

0 patients applied

Trial Officials

Nieto Luis

Study Chair

Site Coordinator of United Medical Group

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported