Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-27 @ 9:39 PM
Study NCT ID:
NCT06267950
Status:
RECRUITING
Last Update Posted:
2024-03-06
First Post:
2024-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Oral Feeding in Infants With Pierre Robin Syndrome
Sponsor:
Zeng Changhao
Organization:
Study Overview
Official Title:
Effect of Oral Feeding in Infants With Pierre Robin Syndrome: A Randomized Controlled Study
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: