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

Institut d'Investigacions Biomèdiques August Pi i Sunyer

Status: Enrolling

Conditions: Fetal Growth Retardation; Intrauterine Growth Restriction

Treatments: Dietary Supplement: Lactoferrin and DHA; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05038462

Fetal Brain Care

Details and patient eligibility

About

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.

Full 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.

Enrollment: 304 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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304 participants in 2 patient groups, including a placebo group

Maternal supplementation with Lactoferrin and DHA

Active Comparator group

Description:

The intervention consists in the maternal oral administration of 1000mg of Lactoferrin and 1000mg of DHA daily

Treatment:

Dietary Supplement: Lactoferrin and DHA

Placebo

Placebo Comparator group

Description:

Product with the same physical appearance and taste as the main intervention but without therapeutic effect

Treatment:

Other: Placebo