Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06238349
Status:
RECRUITING
Last Update Posted:
2024-02-02
First Post:
2024-01-23
Brief Title:
Hyperbilirubinemia in Full-term Neonates
Sponsor:
Zhuhai Center for Maternal and Child Health Care
Organization:
Zhuhai Center for Maternal and Child Health Care
Study Overview
Official Title:
Efficacy and Safety of Sunbathing Plus Bifidobacterium for Hyperbilirubinemia in Full-term Neonates a Prospective Randomized Controlled Study
Status:
RECRUITING
Status Verified Date:
2024-02
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:
HFN
Brief Summary:
To evaluate the efficacy and safety of sunbathing and Bifidobacterium alone or in combination for full-term neonates with hyperbilirubinemia The investigators hypothesize that the combination therapy of sunbathing plus Bifidobacterium is safe and effective for prevention and management of hyperbilirubinemia in full-term neonates The investigators therefore design this prospective randomized controlled study to assess the preventive effects of sunbathing combined with Bifidobacterium supplementation on hyperbilirubinemia in full-term neonates These observations may provide scientific evidence for the use of sunbathing and Bifidobacterium supplementation in the management of hyperbilirubinemia in full-term neonates
Detailed Description:
To evaluate the efficacy and safety of sunbathing and Bifidobacterium alone or in combination for full-term neonates with hyperbilirubinemia The investigators hypothesize that the combination therapy of sunbathing plus Bifidobacterium is safe and effective for prevention and management of hyperbilirubinemia in full-term neonates The investigators therefore design this prospective randomized controlled study to assess the preventive effects of sunbathing combined with Bifidobacterium supplementation on hyperbilirubinemia in full-term neonates A total of 200 neonates treating in Zhuhai Center for Maternal and Child Health Care from Jan 2024 to Jun 2024 will be randomized assigned to either trial groups receiving sunbathing and Bifidobacterium either alone or in combination or control group receiving traditional therapy The primary outcome is the incidence of the hyperbilirubinemia and the secondary outcomes include the hospitalization rate the hospital stays due to hyperbilirubinemia and the bilirubin levels Statistical analyses will be performed using ANOVA or chi-square tests and further pairwise comparisons will be performed using the Bonferroni correction
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NKRDRC2022YFC270480 | OTHER_GRANT | Yuan Shi | None |