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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

304 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-18

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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

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Fetal Growth Retardation Intrauterine Growth Restriction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Maternal supplementation with Lactoferrin and DHA

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

Group Type ACTIVE_COMPARATOR

Lactoferrin and DHA

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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Lactoferrin and DHA

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No