Risk Factor for Cholestasis in Neonates Receiving TPN(Total Parenteral Nutrition)
TPN
1 other identifier
observational
50
0 countries
N/A
Brief Summary
The aim of this study is to evaluate the risk factors of PNAC in neonates
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2022
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 6, 2021
CompletedFirst Posted
Study publicly available on registry
December 20, 2021
CompletedStudy Start
First participant enrolled
July 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 2, 2023
CompletedMay 20, 2022
May 1, 2022
6 months
December 6, 2021
May 15, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
effect of TPN on neonatal liver
TPN associated cholestasis in neonates
baseline
Interventions
early detection of comlications of prolonged TPN on neonatal liver
Eligibility Criteria
All neonates who received PN for≥14days and admitted to our children's hospital's NICU
You may qualify if:
- Neonates who received PN for ≥14 days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Mayyada Elsayed Mohamed Hussien
Study Record Dates
First Submitted
December 6, 2021
First Posted
December 20, 2021
Study Start
July 1, 2022
Primary Completion
January 1, 2023
Study Completion
March 2, 2023
Last Updated
May 20, 2022
Record last verified: 2022-05