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NCT05646940
Fact-based Nutrition for Infants and Lactating Mothers
Conditions: Prematurity
Sex: All
Healthy volunteers: 1
Enrollment: 180
Sponsor: Instituto de Investigacion Sanitaria La Fe
Location: Spain
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.
Eligibility Criteria
Inclusion Criteria:Acceptance of the mother to participate and sign an informed consent formA gestational age < 32 weeks for the group of PI and > 37 weeks for the group of TIExclusive consumption (i.e., >80% v/v of total intake) of either OMM or DHM.Exclusion Criteria:Non-compliance with any of the inclusion criteriaThe requirement of a special diet for the mother (e.g., celiac disease, diabetes) or maternal consumption of probioticsThe need of intestinal surgery, severe congenital malformations, or chromosomopathies of the infantMother's residence outside the Valencian CommunitySevere language barriers hampering the collection of necessary data from mothers not speaking Spanish and/or English
Source: ClinicalTrials.gov (NCT05646940). StuddyBuddy aggregates publicly available trial information.