NCT04723966

Brief Summary

The aim of this work is evaluation of electrolytes and minerals homeostasis and occurrence of complications among preterm babies receiving total parenteral nutrition, and admitted to the neonatal intensive care units of Cairo University Children hospitals.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

April 7, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 26, 2021

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2021

Completed
Last Updated

January 26, 2021

Status Verified

January 1, 2021

Enrollment Period

11 months

First QC Date

January 21, 2021

Last Update Submit

January 21, 2021

Conditions

TPN in Preterm

Outcome Measures

Primary Outcomes (1)

  • electrolyte and mineral disturbance associated with TPN in preterm receiving it

    NA, K, MG, P, CA.

    14 days

Secondary Outcomes (1)

  • prevalence of cholestasis and sepsis in preterm receiving TPN

    14 days

Interventions

TPNDIETARY_SUPPLEMENT

Total parenteral nutrition

Eligibility Criteria

Age1 Day - 1 Month
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

This study will include all male and female preterm infants receiving total parenteral nutrition in NICU of Cairo university Children hospital

You may qualify if:

  • \- All preterm infants with gestational age \< 34 weeks, Receiving total parenteral nutrition. Normal serum magnesium.

You may not qualify if:

  • Any full-term neonates Any patient with TORCH infection, chromosomal, metabolic disorders or surgical abnormality of the hepatobiliary system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Cairo, Almanyal, 11562, Egypt

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

January 21, 2021

First Posted

January 26, 2021

Study Start

April 7, 2019

Primary Completion

March 7, 2020

Study Completion

December 7, 2021

Last Updated

January 26, 2021

Record last verified: 2021-01

Locations

EG(1)