Clinical Tolerance of Numeta 13% (NCT01772927) | Clinical Trial Compass
UnknownNot Applicable
Clinical Tolerance of Numeta 13%
Belgium30 participantsStarted 2013-01
Plain-language summary
Numeta G13% is a triple chamber bag including amino acids plus electrolytes, glucose and lipids, dedicated for parenteral nutrition in preterm newborn infants when oral/enteral nutrition is not possible, insufficient or contra indicated. The product has been registered in 18 countries in Europe via a decentralized procedure that ended 15th December 2010.
The present study want to evaluate the use of Numeta 13% as standard medical prescription in the NICU of the university of Liege. It is a prospective, monocentric, non-interventional, non comparative, open-labeled data collection of record keeping, nutritional intakes from the bags, additional intakes as well as blood and urine biochemical markers currently evaluated in the NICU.
The data will be collected only in VLBWI \< 1500 g receiving Numeta G13% from day of birth (day 1) until parenteral nutrition (PN) decreases below 20% of the targeted intakes 2 days in a row as a quality control of the new solution in clinical practice.
Indication for PN and daily prescription will follow the protocol in use in the NICU on behalf of the investigators
Who can participate
Age range
1 Day – 30 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* All preterm infants\< 1500 g requiring parenteral nutrition from the first day, will be include in the study on the base of consecutive admission rate. However, In order to be representative of the ELBW and VLBW population of NICU, inclusions will be limited to the first 15 VLBW infants of each categories, (\<1000 g, 1000 to \<1250 g and 1250 to \<1500 g). An additional recruitment of 5 infants in each category groups will be necessary to obtain at least 10 infants receiving significant parenteral nutritional supply in the final analysis.
Exclusion Criteria:
* preterm infants who died during the first days of life \< 7 days, preterm infants receiving early oral nutrition with an intake \>50% of the nutritional requirement between 5 to 7 days of life, preterm infants with any contraindication of conventional Parenteral Nutrition (inborn error of metabolism, severe multi-organ failure ) will be exclude from the per protocol analysis.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Protein and energy intakes in the range of the recommendations