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Fact-based Nutrition for Infants and Lactating Mothers

NCT05646940 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 86

Last updated 2024-03-08

No results posted yet for this study

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.

Conditions

  • Prematurity

Sponsors & Collaborators

  • Instituto de Investigacion Sanitaria La Fe

    lead OTHER

Principal Investigators

  • Julia Kuligowski · Instituto de Investigación Sanitaria La Fe

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2022-07-31
Completion
2023-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05646940 on ClinicalTrials.gov