Fact-based Nutrition for Infants and Lactating Mothers

NCT05646940 | Completed

• 1 other identifier: 818110
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Prematurity; Nutrition; Preterm infants; Breastfeeding; Human Milk

Outcome Measures

Primary Outcomes (3)

• Maternal nutrition and HM composition

  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

  To evaluate the effect of pasteurization/storage on DHM composition

  Up to 6 months

• Infants' health

  To evaluate associations between HM composition (OMM or DHM) on growth and other health parameters in PI and TI

  From birth to month 24

Study Arms (3)

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto de Investigacion Sanitaria La Fe: lead

Study Sites (1)

Instituto de Investigación Sanitaria La Fe

Valencia, 46026, Spain

Location

Related Publications (10)

• Ten-Domenech I, Ramos-Garcia V, Pineiro-Ramos JD, Gormaz M, Parra-Llorca A, Vento M, Kuligowski J, Quintas G. Current Practice in Untargeted Human Milk Metabolomics. Metabolites. 2020 Jan 22;10(2):43. doi: 10.3390/metabo10020043.

  PMID: 31979022 BACKGROUND

• Ramos-Garcia V, Ten-Domenech I, Albiach-Delgado A, Gomez-Ferrer M, Sepulveda P, Parra-Llorca A, Campos-Berga L, Moreno-Gimenez A, Quintas G, Kuligowski J. Isolation and Lipidomic Screening of Human Milk Extracellular Vesicles. Methods Mol Biol. 2023;2571:177-188. doi: 10.1007/978-1-0716-2699-3_18.

  PMID: 36152162 BACKGROUND

• Ten-Domenech I, Ramos-Garcia V, Moreno-Torres M, Parra-Llorca A, Gormaz M, Vento M, Kuligowski J, Quintas G. The effect of Holder pasteurization on the lipid and metabolite composition of human milk. Food Chem. 2022 Aug 1;384:132581. doi: 10.1016/j.foodchem.2022.132581. Epub 2022 Feb 26.

  PMID: 35257998 BACKGROUND

• Pineiro-Ramos JD, Parra-Llorca A, Ten-Domenech I, Gormaz M, Ramon-Beltran A, Cernada M, Quintas G, Collado MC, Kuligowski J, Vento M. Effect of donor human milk on host-gut microbiota and metabolic interactions in preterm infants. Clin Nutr. 2021 Mar;40(3):1296-1309. doi: 10.1016/j.clnu.2020.08.013. Epub 2020 Aug 19.

  PMID: 32863061 BACKGROUND

• Poulimeneas D, Bathrellou E, Antonogeorgos G, Mamalaki E, Kouvari M, Kuligowski J, Gormaz M, Panagiotakos DB, Yannakoulia M; NUTRISHIELD Consortium. Feeding the preterm infant: an overview of the evidence. Int J Food Sci Nutr. 2021 Feb;72(1):4-13. doi: 10.1080/09637486.2020.1754352. Epub 2020 Apr 27.

  PMID: 32340495 BACKGROUND

• Ramos-Garcia V, Ten-Domenech I, Vento M, Bullich-Vilarrubias C, Romani-Perez M, Sanz Y, Nobili A, Falcone M, Di Stefano M, Quintas G, Kuligowski J. Fast profiling of primary, secondary, conjugated, and sulfated bile acids in human urine and murine feces samples. Anal Bioanal Chem. 2023 Aug;415(20):4961-4971. doi: 10.1007/s00216-023-04802-8. Epub 2023 Jun 20.

  PMID: 37338567 BACKGROUND

• Ramos-Garcia V, Ten-Domenech I, Moreno-Gimenez A, Campos-Berga L, Parra-Llorca A, Solaz-Garcia A, Lara-Canton I, Pinilla-Gonzalez A, Gormaz M, Vento M, Kuligowski J, Quintas G. GC-MS analysis of short chain fatty acids and branched chain amino acids in urine and faeces samples from newborns and lactating mothers. Clin Chim Acta. 2022 Jul 1;532:172-180. doi: 10.1016/j.cca.2022.05.005. Epub 2022 May 8.

  PMID: 35545167 RESULT

• Akhgar CK, Nurnberger V, Nadvornik M, Ramos-Garcia V, Ten-Domenech I, Kuligowski J, Schwaighofer A, Rosenberg E, Lendl B. Fatty Acid Determination in Human Milk Using Attenuated Total Reflection Infrared Spectroscopy and Solvent-Free Lipid Separation. Appl Spectrosc. 2022 Jun;76(6):730-736. doi: 10.1177/00037028211065502. Epub 2022 Feb 4.

  PMID: 35119320 RESULT

• Ramos-Garcia V, Ten-Domenech I, Moreno-Gimenez A, Campos-Berga L, Parra-Llorca A, Ramon-Beltran A, Vaya MJ, Mohareb F, Molitor C, Refinetti P, Silva A, Rodrigues LA, Rezzi S, Hodgson ACC, Canarelli S, Bathrellou E, Mamalaki E, Karipidou M, Poulimeneas D, Yannakoulia M, Akhgar CK, Schwaighofer A, Lendl B, Karrer J, Migliorelli D, Generelli S, Gormaz M, Vasileiadis M, Kuligowski J, Vento M. Fact-based nutrition for infants and lactating mothers-The NUTRISHIELD study. Front Pediatr. 2023 Apr 18;11:1130179. doi: 10.3389/fped.2023.1130179. eCollection 2023.

  PMID: 37144153 RESULT

• Ramos-Garcia V, Ten-Domenech I, Moreno-Gimenez A, Campos-Berga L, Parra-Llorca A, Gormaz M, Vento M, Karipidou M, Poulimeneas D, Mamalaki E, Bathrellou E, Kuligowski J. Joint Microbiota Activity and Dietary Assessment through Urinary Biomarkers by LC-MS/MS. Nutrients. 2023 Apr 14;15(8):1894. doi: 10.3390/nu15081894.

  PMID: 37111113 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Buccal swab, cord blood, human milk, urine, faeces

MeSH Terms

Conditions

Premature Birth; Breast Feeding

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Feeding Behavior; Behavior

Study Officials

• Julia Kuligowski

  Instituto de Investigación Sanitaria La Fe

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: December 12, 2022
• Study Start: October 1, 2020
• Primary Completion: July 31, 2022
• Study Completion: December 31, 2023
• Last Updated: March 8, 2024

Record last verified: 2024-03

Locations

ES (1)