NCT05038462

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 304 (estimated)
• Sponsor: Institut d'Investigacions Biomèdiques August Pi i Sunyer · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Fetal Growth Retardation
• Intrauterine Growth Restriction

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lactoferrin and DHA	The intervention consists in the maternal oral administration of 1000mg of Lactoferrin and 1000mg of DHA daily
OTHER	Placebo	Product with the same physical appearance and taste as the main intervention but without therapeutic effect

Timeline

• Start date: 2023-01-18
• Primary completion: 2026-09-01
• Completion: 2026-12-01
• First posted: 2021-09-09
• Last updated: 2024-03-18

Locations

6 sites across 1 country: Spain