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

Weight Gain Clinical Trial

— ESIP3CB  

Official title:

Efficacy and Safety of Introducing an Industrially Prepared Ready-to-use 3-Chamber Bag as Parenteral Nutrition Formulation for Premature Infants in Our NICU

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04168749
• Other study ID #: CHUTivoli
• Status: Enrolling by invitation
• Start date: November 15, 2019
• Est. completion date: May 30, 2020

Study information

• Verified date: November 2019
• Source: Centre Hospitalier Universitaire de Tivoli
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: May 30, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 15 Days

Eligibility

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

Related Conditions & MeSH terms

• Intravenous Nutrition Adverse Reaction
• Premature
• Premature Birth
• Weight Gain

Intervention

Combination Product:
• Numeta G13
10 days

Locations

Country	Name	City	State
Belgium	Geneviève Malfilâtre	Soignies

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Tivoli	Baxter Healthcare Corporation

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight gain in grams	grams	6 weeks