NCT05163145

Brief Summary

The aim of this study is to evaluate the risk factors of PNAC in neonates

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2022

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 20, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2023

Completed
Last Updated

May 20, 2022

Status Verified

May 1, 2022

Enrollment Period

6 months

First QC Date

December 6, 2021

Last Update Submit

May 15, 2022

Conditions

Keywords

TPN

Outcome Measures

Primary Outcomes (1)

  • effect of TPN on neonatal liver

    TPN associated cholestasis in neonates

    baseline

Interventions

TPNOTHER

early detection of comlications of prolonged TPN on neonatal liver

Eligibility Criteria

Age1 Day - 28 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

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

Mayyada ElsayedMohamed, resident

CONTACT

Shaimaa MohamedKhala, lecturer

CONTACT

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