CompletedNot Applicable

Early Routine vs. Selective Human Milk Fortification in Extremely Preterm Infants

United States170 participantsStarted 2020-02-15

Plain-language summary

The aim of the project is to study the effects of fortification (using a Human Milk Donor Fortifier) of an exclusive preterm human milk diet on outcome of extremely preterm neonates, born at less or equal to 27 weeks.

Who can participate

Age range

0 Days – 6 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 extremely preterm infants with gestational age less or equal to 27 weeks who are admitted to the NICU prior to day of life seven and the first enteral feeding Exclusion Criteria: * Infants with severe congenital anomalies such as chromosomal trisomy, congenital heart disease, and abdominal wall defect

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

In-Hospital growth in extremely preterm infants

Timeframe: Remaining length of NICU admission from the time of randomization (approximately 2 years from recruitment starts)

Necrotizing Enterocolitis (NEC)

Timeframe: Remaining length of NICU admission from the time of randomization (approximately 2 years from recruitment starts)

Neurodevelopmental outcome

Timeframe: Assessment will happen at two years adjusted age ( approximately 4 years from the time recruitment starts)

Trial details

NCT IDNCT04284280

SponsorCrouse Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-31

View on ClinicalTrials.gov More Poor Growth in Extremely Preterm Infants trials

Who can participate

Age range

0 Days – 6 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.

What they're measuring

In-Hospital growth in extremely preterm infants

Timeframe: Remaining length of NICU admission from the time of randomization (approximately 2 years from recruitment starts)

Necrotizing Enterocolitis (NEC)

Timeframe: Remaining length of NICU admission from the time of randomization (approximately 2 years from recruitment starts)

Neurodevelopmental outcome

Timeframe: Assessment will happen at two years adjusted age ( approximately 4 years from the time recruitment starts)