Weight GainESIP3CBNCT04168749
Efficacy and Safety of Industrially Prepared 3 Chamber Bag Parenteral Nutrition for Premature Infant
An observational study of Weight Gain and Intravenous Nutrition Adverse Reaction, run by Centre Hospitalier Universitaire de Tivoli at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 1 day to 15 days
- Conditions the study is for
- Weight Gain, Intravenous Nutrition Adverse Reaction, Premature
- What is being tested?
- Numeta G13
- How many people
- 200 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Nov 2019to 30 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 15 days
- All sexes
- No healthy volunteers
- Child
Study population: premature patients in the NICUs with a birth weight between 1250 and 2000g
Who may be able to join
- premature patients in the NICUs with a birth weight between 1250 and 2000g
Who cannot join
- death or parenteral duration less than 10 days
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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.
- Being tested
- Numeta G13
- Medical subject headings
- Weight Gain, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Numeta G13Combination product
Also called parenteral nutrition for premature infant
10 days
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Combination Product: Numeta G13 |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight gain in grams
grams
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start15 Nov 2019
- Primary completion30 Mar 2020 (estimated)
- Study completion30 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight GainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Tivoli
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Sponsor
- Investigators
- Geneviève Malfilâtre, Principal investigator, Centre Hospitalier Universitaire de Tivoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04168749
- Sponsor's protocol ID
- CHUTivoli
- Acronym
- ESIP3CB
- Status last verified
- Nov 2019
- First submitted
- 15 Nov 2019
- Last updated
- 19 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04168749
- Acronym / sponsor ID
- ESIP3CB / CHUTivoli
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de TivoliUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- 15 Nov 2019 (actual)
- Primary completion
- 30 Mar 2020 (estimated)
- Study completion
- 30 May 2020 (estimated)
- First posted
- 19 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Combination Product: Numeta G13the first 100 preterm babies as from January 1 2017 with a birth weight between 1250-2000g that received at least 10 days of TPN |
Who may qualify
- Ages
- 1 day to 15 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- premature patients in the NICUs with a birth weight between 1250 and 2000g
Key inclusion criteria (1 listed)
- premature patients in the NICUs with a birth weight between 1250 and 2000g
Key exclusion criteria (1 listed)
- death or parenteral duration less than 10 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Numeta G13Also: parenteral nutrition for premature infant10 days | Combination product | Numeta G13 group |
Primary outcome
weight gain in grams
Time frame: 6 weeks
grams
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
- Individual participant dataSharing planned: No
Related trials for Weight Gain
Recruiting
An Online Intuitive Eating Program for Pregnant Women With Obesity to Support Well-Being
Excessive Gestational Weight Gain, Pregnancy
RecruitingPhase 3
Weight Gain Prevention in Adolescents and Young Adults
Healthy Volunteers
Recruiting
Time Restricted Eating for WeIght LoSs MainTenance-2
Weight Loss, Weight Gain
Enrolling by invitationObservational study
Changes in Body Composition Following Pharmacological Treatment for Obesity.
Obesity (BMI Equal to or >30), Weight Regain After Bariatric Surgery
Recruiting
A Relation Between Craving Induction and Treatment Response in Deep Transcranial Magnetic Stimulation (dTMS) for Reducing Antipsychotic-induced Weight Gain in Schizophrenia
Schizophrenia, Antipsychotic Induced Weight Gain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geneviève Malfilâtre principal investigator
Centre Hospitalier Universitaire de Tivoli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Weight Gain and Intravenous Nutrition Adverse Reaction, run by Centre Hospitalier Universitaire de Tivoli at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight gain in grams (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2019.