Efficacy and Safety of Industrially Prepared 3 Chamber Bag Parenteral Nutrition for Premature Infant

NCT ID: NCT04168749

Last Updated: 2019-11-19

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-11-15
• Study Completion Date: 2020-05-30

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

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.

Conditions

Weight Gain; Intravenous Nutrition Adverse Reaction; Premature

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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

Numeta G13

Intervention Type: COMBINATION_PRODUCT

10 days

Interventions

Numeta G13

10 days

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

parenteral nutrition for premature infant

Eligibility Criteria

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 15 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Tivoli

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Geneviève Malfilâtre

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Tivoli

Locations

Geneviève Malfilâtre

Soignies, , Belgium

Countries

Belgium

Other Identifiers

CHUTivoli

Identifier Type: -

Identifier Source: org_study_id