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Singleton pregnancies being diagnosed of fetal growth restriction from 24 to 32.6 weeks of gestation will be randomized to two equally sized groups: maternal oral supplementation with Lactoferrin and DHA (Docosahexaenoic acid) or placebo.
Randomized controlled trial among pregnant women that have been diagnosed of fetal growth restriction. These women will be randomized in order to evaluate the impact of maternal supplementation with Lactoferrin and DHA on the neurodevelopment outcome of their babies. Main hypothesis: a prenatal intervention based on maternal supplementation with Lactoferrin and DHA improves neurodevelopment in fetal growth restriction. Secondary hypothesis are that a prenatal intervention based on maternal supplementation with Lactoferrin and DHA in fetal growth restriction improves fetal growth and improves perinatal morbidity and mortality.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Hospital Clínic de Barcelona
Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital del Mar
Barcelona, Spain
Hospital Dexeus-Quirón
Barcelona, Spain
Hospital Sant Joan de Déu
Esplugues de Llobregat, Spain
Hospital General del Hospitalet
L'Hospitalet de Llobregat, Spain
Start Date
January 18, 2023
Primary Completion Date
September 1, 2026
Completion Date
December 1, 2026
Last Updated
March 18, 2024
304
ESTIMATED participants
Lactoferrin and DHA
DIETARY_SUPPLEMENT
Placebo
OTHER
Lead Sponsor
Institut d'Investigacions Biomèdiques August Pi i Sunyer
Collaborators
NCT06952777
NCT04720690
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT02583763