Fact-based Nutrition for Infants and Lactating Mothers (NUTRISHIELD)

March 6, 2024 updated by: Julia Kuligowski, Instituto de Investigacion Sanitaria La Fe

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

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 Overview

Status

Completed

Conditions

Detailed Description

The genotype, metabolome, and microbiota as well as the HM composition (i.e., macronutrients, fatty acids, vitamins, human milk oligosaccharides, and steroids) are characterized. Portable sensor prototypes for the analysis of HM and urine are benchmarked. Additionally, maternal psychosocial status is measured at the beginning of the study and at month six, including social support, family functioning, perceived stress, anxiety, and depression symptoms, and traumatic life events. Mother-infant postpartum bonding and parental stress is also examined. At six months (corrected age for preterm groups), infant neurodevelopment scales are applied. Mother's concerns and attitudes to breastfeeding are also registered through a specific questionnaire at CEN/RBW and six months. An additional assessment at two years (corrected age for PI) is conducted, in order to study long-term effects on neurodevelopment. Current knowledge on the importance of diet and other environmental factors for infant growth, health, and development is limited and donor-matching at HM banks is frequently only based on gestational age and total protein content of HM. NUTRISHIELD provides an in-depth longitudinal study of the mother-infant-microbiota triad combining multiple biological matrices, newly developed analytical methods, and ad-hoc designed sensor prototypes with a wide range of clinical outcome measures. Data obtained from this study will be used to train a machine-learning algorithm for providing dietary advice to lactating mothers and will be implemented in a user-friendly platform based on a combination of user-provided information and biomarker analysis. A better understanding of the factors affecting the milk's composition, together with the health implications for infants plays an important role in developing improved strategies of nutraceutical management in infant care.

Study Type

Observational

Enrollment (Actual)

86

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain, 46026
        • Instituto de Investigación Sanitaria La Fe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Three mother-infant groups were enrolled, i.e., PI-OMM, PI-DHM, and TI-OMM, and their mothers.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
PI-OMM
25 PI fed with OMM and their mothers
PI-DHM
25 PI fed with DHM and their mothers
TI-OMM
25 TI fed with OMM and their mothers as control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infants' health
Time Frame: From birth to month 24
To evaluate associations between HM composition (OMM or DHM) on growth and other health parameters in PI and TI
From birth to month 24
Maternal nutrition and HM composition
Time Frame: From birth to 6 months
Evaluate associations between the mother's diet and HM composition in PI and TI (i.e., how the potential association between mother's diet and HM nutrient composition is affected by prematurity), and between HM composition and mother's physical and psychosocial status (e.g., lifestyle, perceived stress, anxiety and depression)
From birth to 6 months
HM pasteurization
Time Frame: Up to 6 months
To evaluate the effect of pasteurization/storage on DHM composition
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Investigacion Sanitaria La Fe

Investigators

  • Principal Investigator: Julia Kuligowski, Instituto de Investigación Sanitaria La Fe

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Actual)

July 31, 2022

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

December 2, 2022

First Submitted That Met QC Criteria

December 2, 2022

First Posted (Actual)

December 12, 2022

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 818110

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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