CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 86 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05646940
NCT05646940N/ACompleted

Fact-based Nutrition for Infants and Lactating Mothers - The NUTRISHIELD Study

Instituto de Investigacion Sanitaria La Fe·observational·Posted Dec 12, 2022·Updated Mar 8, 2024

In Brief

An observational study for Prematurity. Completed, enrolled 86 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsPrematurity
CountriesSpain
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedDec 12, 2022
Enrollment StartOct 1, 2020
Primary CompletionJul 31, 2022
Study CompletionDec 31, 2023
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 3.6 years ago