PrematurityNUTRISHIELDNCT05646940
Fact-based Nutrition for Infants and Lactating Mothers
An observational study of Prematurity, run by Instituto de Investigacion Sanitaria La Fe at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Prematurity
- How many people
- 86 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2020to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Three mother-infant groups were enrolled, i.e., PI-OMM, PI-DHM, and TI-OMM, and their mothers.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Prematurity
- Keywords
- Prematurity, Nutrition, Preterm infants, Breastfeeding, Human Milk
- Medical subject headings
- Premature Birth, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: From birth to 6 months
HM pasteurization
To evaluate the effect of pasteurization/storage on DHM composition
Measured: 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
Measured: From birth to month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start1 Oct 2020
- Primary completion31 Jul 2022
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for PrematurityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigacion Sanitaria La Fe
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julia Kuligowski, Instituto de Investigacion Sanitaria La Fe
- Investigators
- Julia Kuligowski, Principal investigator, Instituto de Investigación Sanitaria La Fe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05646940
- Sponsor's protocol ID
- 818110
- Acronym
- NUTRISHIELD
- Status last verified
- Mar 2024
- First submitted
- 2 Dec 2022
- Last updated
- 8 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31979022Ramos-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.
PubMed 36152162Ten-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.
PubMed 35257998Pineiro-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.
PubMed 32863061Poulimeneas 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.
PubMed 32340495Ramos-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.
PubMed 37338567Ramos-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.
PubMed 35545167Akhgar 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.
PubMed 35119320Ramos-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.
PubMed 37144153Ramos-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.
PubMed 37111113
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fact-based Nutrition for Infants and Lactating Mothers - The NUTRISHIELD Study
- ClinicalTrials.gov ID
- NCT05646940
- Acronym / sponsor ID
- NUTRISHIELD / 818110
- Conditions
- Prematurity
- Keywords
- Prematurity, Nutrition, Preterm infants, Breastfeeding, Human Milk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Instituto de Investigacion Sanitaria La FeUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 12 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Three mother-infant groups were enrolled, i.e., PI-OMM, PI-DHM, and TI-OMM, and their mothers.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
HM pasteurization
Time frame: Up to 6 months
To evaluate the effect of pasteurization/storage on DHM composition
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Background: PubMed 31979022Ten-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.
- Background: PubMed 36152162Ramos-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.
- Background: PubMed 35257998Ten-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.
- Background: PubMed 32863061Pineiro-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.
- Background: PubMed 32340495Poulimeneas 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.
- Background: PubMed 37338567Ramos-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.
- Results publication: PubMed 35545167Ramos-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.
- Results publication: PubMed 35119320Akhgar 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.
- Results publication: PubMed 37144153Ramos-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.
- Results publication: PubMed 37111113Ramos-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia Kuligowski principal investigator
Instituto de Investigación Sanitaria La Fe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prematurity, run by Instituto de Investigacion Sanitaria La Fe at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal nutrition and HM composition (time frame: From birth to 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05646940, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.