CompletedPhase 4

Zinc Supplementation In Very Low Birth Weight Infants-A Randomised Controlled Trial

Turkey (Türkiye)195 participantsStarted 2014-03-14

Plain-language summary

* Zinc (Zn) is a structural component of human body and is a crucial element for a wide variety of cascades that take place in almost all organ systems. * Due to many reasons, preterm infants are generally believed to be naturally in a negative Zn balance during the early periods of life. * Regulation of intestinal Zn absorption of preterms is unrelated to infant's Zn status. * There still is a lack of knowledge in the possible relation of Zn deficiency and development of NEC and/or feeding intolerance in preterm infants. * Even if Zn is studied as an adjunct treatment for neonates and young infants with sepsis and found to reduce treatment failure in these high risk population, data in preventing infectious diseases in preterm infants is still lacking.

Who can participate

Age range

7 Days – 9 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: * \< 32 weeks gestational age and/or \<1500 gr birth weight * Born in the study hospital * Being able to be fed enterally, even in very small amounts, regardless of the volume of the nutrient Exclusion Criteria: * Major congenital malformations and/or critical congenital heart defects * Born in another hospital * Severe birth asphyxia * Severe sepsis * Previous early-onset NEC history * Infants on the intervention arm who did not continue Zinc supplementation during the study period * Hemodynamically unstability * Infants nil per os * No consent from the family * Death before the 7th day of life

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

Incidence of feeding intolerance

Timeframe: through study completion, an average of 6 months

Trial details

NCT IDNCT05311540

SponsorZekai Tahir Burak Women's Health Research and Education Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-03-02

View on ClinicalTrials.gov More Preterm Infant trials