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Fetal Brain Care: Therapies for Brain Neurodevelopment in Fetal Growth Restriction

Fetal Brain Care: Therapies for Brain Neurodevelopment in Fetal Growth Restriction

Recruiting
18 years and older
Female
Phase N/A

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Overview

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.

Description

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.

Eligibility

Inclusion Criteria:

  • Singleton pregnancies
  • Non-malformed fetus
  • Pregnancies with fetal growth restriction
  • 24-32.6 weeks of gestation

Exclusion Criteria:

  • Chromosomal or structural abnormalities diagnosed during pregnancy or in the neonatal period
  • Critical Doppler study suggesting the need for delivery within the next 14 days at the time of diagnosis: reverse end-diastolic velocity in the umbilical artery or ductus venosus pulsatility \>95th centile
  • Maternal mental or psychiatric disorders
  • Maternal allergy to cow's milk protein

Study details
    Fetal Growth Retardation
    Intrauterine Growth Restriction

NCT05038462

Institut d'Investigacions Biomèdiques August Pi i Sunyer

14 May 2026

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