CompletedNot Applicable

Weight Gain in Extremely Premature Infant With Targeted Versus Adjusted Fortification

Spain38 participantsStarted 2021-04-19

Plain-language summary

Investigation about the effect on weight gain in extremely low birth weight preterm with individualized fortification, according to human milk analysis versus fortification adjusted according to urea serum concentration.

Who can participate

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

. Preterm infants born \<1000 g of birth weight that are fed with breast milk or donated milk.
. Written informed consent signed by the mother, father or legal guardian.
. To tolerate enteral feeding, at least 100mL / kg / day.

Exclusion criteria

. Non-premature or premature patients weighing ≥ 1000 gr.
. Patients with major malformations.
. Patients with diagnosed chromosomal diseases or of high diagnostic suspicion.
. Patients with short bowel syndrome or any surgery on the gastrointestinal tract.

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

Growth rate 28 days after the start of fortification and birth

Timeframe: 28 days

Trial details

NCT IDNCT04982133

SponsorHospital Universitario La Paz

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-04-30

View on ClinicalTrials.gov More Preterm trials

Who can participate

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

. Preterm infants born \<1000 g of birth weight that are fed with breast milk or donated milk.
. Written informed consent signed by the mother, father or legal guardian.
. To tolerate enteral feeding, at least 100mL / kg / day.

Exclusion criteria

. Non-premature or premature patients weighing ≥ 1000 gr.
. Patients with major malformations.
. Patients with diagnosed chromosomal diseases or of high diagnostic suspicion.
. Patients with short bowel syndrome or any surgery on the gastrointestinal tract.