UnknownNot Applicable

Effect of Target Fortified Human Milk on the Growth Quality of Very Preterm Infants (TargetFort)

Portugal80 participantsStarted 2020-02-01

Plain-language summary

It is reported that the standard method for fortification of human milk (HM) overestimates the energy and protein densities of HM (Macedo MHNP 2018), thus originating infant undernutrition (Macedo AJP 2018). The target fortification, based on analysis of HM composition, is considered the gold-standard method (Rochow 2015, McLeod 2016). This observational mixed cohort study aims to assess if very preterm infants fed HM with target fortification have greater growth during hospital stay and better body composition at term post-menstrual age (PMA), than those fed HM with standard fortification.

Who can participate

Age range

1 Day

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: * newborn infants born at \<33 weeks of gestation, * admitted to the NICU of Maternidade Dr. Alfredo da Costa (inborns and outborns), * exclusively or predominantly HM fed (\>87.5% volume per day) * discharged alive. Exclusion Criteria: * multiples of grade \>2 * diagnosis of innate metabolism disorder, * fed with formula for \>12.5% of the daily volume intake for two or more consecutive full days , * discharge with transference to other hospital, * unavailable for body composition analysis after discharge.

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

weight gain velocity rate

Timeframe: from baseline (the first day of exclusive or predominantly feeding with fortified human milk) up to 40 weeks postmenstrual age or to home discharge, whatever comes first

length velocity rate

Timeframe: from baseline (the first day of exclusive or predominantly feeding with fortified human milk) up to 40 weeks postmenstrual age or to home discharge, whatever comes first

head circumference velocity rate

Timeframe: from baseline (the first day of exclusive or predominantly feeding with fortified human milk) up to 40 weeks postmenstrual age or to home discharge, whatever comes first

adiposity (fat mass index)

Timeframe: A single measurement performed up to 10 days after home discharge

Trial details

NCT IDNCT04400396

SponsorCentro Hospitalar de Lisboa Central

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-06-30

View on ClinicalTrials.gov More Growth trials

Plain-language summary

Who can participate

Age range

1 Day

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

weight gain velocity rate

Timeframe: from baseline (the first day of exclusive or predominantly feeding with fortified human milk) up to 40 weeks postmenstrual age or to home discharge, whatever comes first

length velocity rate

Timeframe: from baseline (the first day of exclusive or predominantly feeding with fortified human milk) up to 40 weeks postmenstrual age or to home discharge, whatever comes first

head circumference velocity rate

Timeframe: from baseline (the first day of exclusive or predominantly feeding with fortified human milk) up to 40 weeks postmenstrual age or to home discharge, whatever comes first

adiposity (fat mass index)

Timeframe: A single measurement performed up to 10 days after home discharge