Safety and Efficacy Evaluation of TPN in Preterm Neonates... | NCT04723966

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

NCT04723966

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Jan 26, 2021Actual

Enrollment

200Actual

Phase

Not provided

Conditions

TPN in Preterm

Interventions

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 7, 2019Actual

Primary Completion Date

Mar 7, 2020Actual

Completion Date

Dec 7, 2021Estimated

First Submitted Date

Jan 21, 2021

First Submission Date that Met QC Criteria

Jan 21, 2021

First Posted Date

Jan 26, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 21, 2021

Last Update Posted Date

Jan 26, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Name	Type	Description	Arm Group Labels	Other Names
TPN	Dietary Supplement	Total parenteral nutrition

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

1 Month

Standard Ages

Child

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine		Cairo	Almanyal	11562	Egypt