Safety and Efficacy Evaluation of TPN in Preterm Neonates in NICU of Cairo University Children Hospital

January 21, 2021 updated by: Khalid Mohammed Shehata, Cairo University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Almanyal
      • Cairo, Almanyal, Egypt, 11562
        • Faculty of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 month (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
electrolyte and mineral disturbance associated with TPN in preterm receiving it
Time Frame: 14 days
NA, K, MG, P, CA.
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prevalence of cholestasis and sepsis in preterm receiving TPN
Time Frame: 14 days
clinical and laboratory examination
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 2019

Primary Completion (Actual)

March 7, 2020

Study Completion (Anticipated)

December 7, 2021

Study Registration Dates

First Submitted

January 21, 2021

First Submitted That Met QC Criteria

January 21, 2021

First Posted (Actual)

January 26, 2021

Study Record Updates

Last Update Posted (Actual)

January 26, 2021

Last Update Submitted That Met QC Criteria

January 21, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS- 110-2019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on TPN in Preterm

Clinical Trials on TPN

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uganda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe