CompletedNot Applicable

Fact-based Nutrition for Infants and Lactating Mothers

Spain86 participantsStarted 2020-10-01

Plain-language summary

Human milk (HM) is the ideal source of nutrients for infants, but its composition is highly variable. When not enough own mother's milk (OMM) is available, the administration of pasteurized donor human milk (DHM) is considered the best alternative for feeding preterm infants (PI). The aim of this study is to evaluate the influence of diet, lifestyle habits, psychological stress, and pasteurization on the milk composition, and how it modulates infant's growth, health, and development. NUTRISHIELD is a prospective mother-infant birth cohort in the Spanish-Mediterranean area including three groups: PI \<32 weeks of gestation (i) exclusively receiving OMM (i.e., \>80% v/v of total intake), and (ii) exclusively receiving DHM, and (iii) term infants (TI) exclusively receiving OMM, as well as their mothers, and HM donors. Biological samples and nutritional, clinical, and anthropometric characteristics are collected at six time points covering the period from birth and until six months of infant's age (complete enteral nutrition (CEN) / recovery birth weight (RBW), and one, two, three, and six months). An additional assessment at two years (corrected age for PI) is conducted, in order to study long-term effects on neurodevelopment.

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: * Acceptance of the mother to participate and sign an informed consent form * A gestational age \< 32 weeks for the group of PI and \> 37 weeks for the group of TI * Exclusive consumption (i.e., \>80% v/v of total intake) of either OMM or DHM. Exclusion Criteria: * Non-compliance with any of the inclusion criteria * The requirement of a special diet for the mother (e.g., celiac disease, diabetes) or maternal consumption of probiotics * The need of intestinal surgery, severe congenital malformations, or chromosomopathies of the infant * Mother's residence outside the Valencian Community * Severe language barriers hampering the collection of necessary data from mothers not speaking Spanish and/or English

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

Maternal nutrition and HM composition

Timeframe: From birth to 6 months

HM pasteurization

Timeframe: Up to 6 months

Infants' health

Timeframe: From birth to month 24

Trial details

NCT IDNCT05646940

SponsorInstituto de Investigacion Sanitaria La Fe

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-07-31

View on ClinicalTrials.gov More Prematurity trials

Plain-language summary

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.