Usefulness of Protein-enriched Infant Formula in Pediatric Intensive Care. (NCT03901742) | Clinical Trial Compass
UnknownNot Applicable
Usefulness of Protein-enriched Infant Formula in Pediatric Intensive Care.
Spain90 participantsStarted 2016-12-28
Plain-language summary
A multicenter prospective randomized controlled trial (RCT) will be performed in three hospitals. Patients meeting inclusion criteria will be randomly allocated to one of three enteral feeding formula with different protein content. Blood and urine test, nitrogen balance assessment and energy expenditure testing by indirect calorimetry will be performed at the beginning of nutrition regimen and at 24 hours, 72 hours and 5-7 days after initiation. The sample size for this trial is estimated as 90 participants, with approximately 30 participants in each group. The data analysis will be by intention to treat. This RCT will provide new data about the amount of protein needed to improve levels of serum protein and nitrogen balance, surrogate of protein balance, in critically ill infants receiving enteral nutrition.
Who can participate
Age range
1 Month – 2 Years
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
. Children aged 1 month to 2 years.
. Children admitted to PICU.
. Children receiving enteral nutrition with an estimated length of over 72 hours.
Exclusion criteria
. Age less than 1 month or over 2 years.
. Diabetes mellitus or any inborn metabolic error.
. Parenteral nutrition.
. Bicarbonate infusion.
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
Nitrogen balance variation
Timeframe: From date of randomization until the date of first documented progression or date of discharge, whichever came first, assessed up to 7 days
2
Proportion of patients that meet study ending criteria
Timeframe: From date of randomization until the date of first documented progression or date of discharge, whichever came first, assessed up to 7 days
Trial details
NCT IDNCT03901742
SponsorHospital General Universitario Gregorio Marañon