Maternal supplementation to improve fetal brain development in growth-restricted pregnancies
Official title: Fetal Brain Care: Therapies for Brain Neurodevelopment in Fetal Growth Restriction
Run by Institut d'Investigacions Biomèdiques August Pi i Sunyer · NCT05038462 · Data updated 2026-11-12
This study is testing if giving pregnant women supplements to help their babies' brain development can improve outcomes for babies who are not growing well in the womb.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 304 (estimated) |
| Sponsor | Institut d'Investigacions Biomèdiques August Pi i Sunyer Academic / other |
| Locations | 6 sites (Barcelona and 5 other locations) |
| Status | Recruiting |
| Started | January 18, 2023 |
| Main results expected | September 2028 |
| Study ends | December 2028 |
| Registry record updated | November 9, 2026 |
| Trial ID | NCT05038462 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are pregnant women with singleton pregnancies diagnosed with fetal growth restriction between 24 and 32.6 weeks of gestation.
✕Probably not a fit
Patients with chromosomal or structural abnormalities, critical Doppler findings necessitating immediate delivery, or maternal psychiatric disorders may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effects of maternal oral supplementation with Lactoferrin and DHA on the neurodevelopment of babies diagnosed with fetal growth restriction between 24 to 32.6 weeks of gestation. Pregnant women will be randomly assigned to receive either the active supplements or a placebo. The primary goal is to determine if this prenatal intervention can enhance neurodevelopment outcomes, while secondary objectives include assessing improvements in fetal growth and reductions in perinatal morbidity and mortality.
Why it matters
Potential benefit: If successful, this intervention could lead to improved neurodevelopmental outcomes for infants affected by fetal growth restriction.
How similar studies have gone: While the approach of using maternal supplementation for fetal development is explored in other studies, this specific combination of Lactoferrin and DHA in the context of fetal growth restriction is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Hospital Clínic de Barcelona
Barcelona, Spain Recruiting -
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain Recruiting -
Hospital del Mar
Barcelona, Spain Recruiting -
Hospital Dexeus-Quirón
Barcelona, Spain Recruiting -
Hospital Sant Joan de Déu
Esplugues de Llobregat, Spain Recruiting -
Hospital General del Hospitalet
L'Hospitalet de Llobregat, Spain Recruiting
Study contacts
- Study coordinator: Elisenda Eixarch, MD; PhD
- Email: eixarch@clinic.cat
- Phone: 0034 932279333
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.