NCT04168749

Brief Summary

This study was designed to evaluate whether industrially prepared standardizing total parenteral nutrition is at least non-inferior to compounded TPN and provides nutritional intakes according to the new guidelines and provides the expected weight gain in preterm babies with a birth weight between 1250 and 2000g admitted in our NICU between 2015 \& 2018

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 Nov 2019

Shorter than P25 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

First Submitted

Initial submission to the registry

November 15, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

November 15, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 19, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2020

Completed
Last Updated

November 19, 2019

Status Verified

November 1, 2019

Enrollment Period

5 months

First QC Date

November 15, 2019

Last Update Submit

November 16, 2019

Conditions

Weight GainIntravenous Nutrition Adverse ReactionPremature

Outcome Measures

Primary Outcomes (1)

  • weight gain in grams

    grams

    6 weeks

Study Arms (2)

local compounding group

the first 100 preterm babies born as from January 1 2015 with a birth weight between 1250-2000g that received at least 10 days of TPN.

Numeta G13 group

the first 100 preterm babies as from January 1 2017 with a birth weight between 1250-2000g that received at least 10 days of TPN

Combination Product: Numeta G13

Interventions

Numeta G13COMBINATION_PRODUCT

10 days

Also known as: parenteral nutrition for premature infant
Numeta G13 group

Eligibility Criteria

Age1 Day - 15 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

premature patients in the NICUs with a birth weight between 1250 and 2000g

You may qualify if:

  • premature patients in the NICUs with a birth weight between 1250 and 2000g

You may not qualify if:

  • death or parenteral duration less than 10 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geneviève Malfilâtre

Soignies, 7061, Belgium

Location

MeSH Terms

Conditions

Weight GainPremature Birth

Interventions

Parenteral Nutrition

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Feeding MethodsTherapeuticsNutritional SupportNutrition Therapy

Study Officials

  • Geneviève Malfilâtre

    Centre Hospitalier Universitaire de Tivoli

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2019

First Posted

November 19, 2019

Study Start

November 15, 2019

Primary Completion

March 30, 2020

Study Completion

May 30, 2020

Last Updated

November 19, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)