CompletedNot Applicable

Human Milk Cream as a Caloric Supplement in Pre-Term Infants

United States78 participantsStarted 2011-12

Plain-language summary

Human milk is commonly considered to have 20 calories per ounce (kcal/oz). However, studies show that up to 65% of human milk may be less than the expected 20 kcal/oz which can greatly affect an infant's growth. The investigators now have the ability to measure caloric density of human milk and add human milk cream to any human milk (mother's own or donor human milk) that is less than 20 kcal/oz to bring it up to that amount.

Who can participate

Age range

21 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: * Birth weight 750 - 1250g * Able to adhere to expected feeding protocol of mother's own milk/donor milk with fortification of Prolacta® fortifier * Reasonable expectation of survival * Enteral feeding must begin before the 21st day of life Exclusion Criteria: * Decision to not start minimum enteral feed before day 21 of life * Unable to obtain informed consent from parent/guardian prior to the initiation of fortification of enteral feeding * Enrolled in any other clinical study affecting nutritional management during the study period * Presence of clinically significant congenital heart disease or major congenital malformations * Reasonable potential for early transfer to a non-study institution

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

Caloric content of human milk

Timeframe: Daily until 36 weeks corrected gestational age

Trial details

NCT IDNCT01487928

SponsorBaylor College of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-06

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