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Study of Lactoferrin and DHA Supplements in Pregnant Women with Fetal Growth Restriction Impact on Babys Brain Development and Birth Outcomes
Led by Institut d'Investigacions Biomèdiques August Pi i Sunyer · Updated on 2024-03-18
304
Participants Needed
6
Research Sites
13 weeks
Total Duration
AI-Summary
What this Trial Is About
This research aims to evaluate the effects of maternal supplementation with Lactoferrin and DHA on brain development in babies diagnosed with fetal growth restriction during pregnancy. Pregnant women carrying singleton pregnancies with fetal growth restriction between 24 and 32.6 weeks of gestation will be studied to see if this prenatal intervention improves neurodevelopment outcomes. Secondary goals include assessing improvements in fetal growth and reductions in perinatal complications. Participants will be randomly assigned to one of two groups one receiving daily oral supplements of 1000mg Lactoferrin and 1000mg DHA, and the other receiving a placebo that looks and tastes the same but lacks active ingredients. The supplementation continues until delivery. This study uses a quadruple-masked design to ensure unbiased results. During the study, babies neurodevelopment will be assessed using the Bayley III scale at 24 months corrected age. Researchers will also measure fetal brain development through scans at 32, 34, and 36 weeks of gestation, track neonatal weight at birth, and monitor perinatal health through the first four weeks after birth. Safety and any adverse effects during supplementation will be closely observed. The total participation time spans from diagnosis during pregnancy until two years after birth.
CONDITIONS
Brief Title
Fetal Brain Care: Therapies for Brain Neurodevelopment in Fetal Growth Restriction
Research Team
E
Elisenda Eixarch, MD; PhD
E
Elena Monterde, MD
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