- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04168749
Efficacy and Safety of Industrially Prepared 3 Chamber Bag Parenteral Nutrition for Premature Infant (ESIP3CB)
November 16, 2019 updated by: Centre Hospitalier Universitaire de Tivoli
Efficacy and Safety of Introducing an Industrially Prepared Ready-to-use 3-Chamber Bag as Parenteral Nutrition Formulation for Premature Infants in Our NICU
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
Study Overview
Status
Unknown
Intervention / Treatment
Detailed Description
Parenteral nutrition (PN) is mandatory in the nursing of very low birth weight ((V)LBW)) babies during the first weeks of life.
Numerous discussions exist about the indication of individually tailored or standardized PN formula.
(V)LBW babies are known as fragile unstable babies with special requirements.
Many neonatal intensive care units (NICU) prefer a tailored prescription for that kind of patients.
Making a daily individual tailored prescription is often complex for numerous reasons: it is time consuming, it may be source of faults and incompatibility, it needs a senior neonatologist to review the prescription and has to arrive during daytime hours at the pharmacy.
Tailored PN is often administrated with a delay, as one can only prescribe having reviewed the results of blood sampling.
This delay can range from 6 to 12 hours.
Numeta G13°/0E is a standardized, industrial, ready to use PN specifically designed to meet the nutritional requirements of preterm newborn infants for whom enteral nutrition is not possible or insufficient.
New Espghan guidelines were published in 2018 recommending nutritional intake targets of 2.5g-3.5 amino acids per kg/day and 90-120 kcal/kg/day.
Our NICU wants to evaluate their compliance to these new guidelines.
Before November 2016, it was common practice in CHU Tivoli to feed the preterm baby with a compounded binary TPN solution and lipids were administered separately in Y-line.
In November 2016, we switched to an all-in-one TPN with standardized composition (Numeta G13%E, Baxter) Numeta G13°/0E is stored at room temperature and is ready to be infused in a few minutes.
Numeta G13%E is presented in the form of a three-chamber bag (3CB) or a two chamber bag (2CB).
The activation of the lipid bag is optional, resulting in a solution containing glucose, electrolytes, amino acids and (optionally) lipids.
Additions of water, electrolytes in the bag or on the side help to customize the bag to the specific needs of newborns that need intensive care.
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
-
-
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Soignies, Belgium, 7061
- Geneviève Malfilâtre
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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 2 weeks (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
premature patients in the NICUs with a birth weight between 1250 and 2000g
Description
Inclusion Criteria:
- premature patients in the NICUs with a birth weight between 1250 and 2000g
Exclusion Criteria:
- death or parenteral duration less than 10 days
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: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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
|
10 days
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
weight gain in grams
Time Frame: 6 weeks
|
grams
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Geneviève Malfilâtre, CHU Tivoli
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)
November 15, 2019
Primary Completion (Anticipated)
March 30, 2020
Study Completion (Anticipated)
May 30, 2020
Study Registration Dates
First Submitted
November 15, 2019
First Submitted That Met QC Criteria
November 16, 2019
First Posted (Actual)
November 19, 2019
Study Record Updates
Last Update Posted (Actual)
November 19, 2019
Last Update Submitted That Met QC Criteria
November 16, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUTivoli
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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.
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