Maternal supplementation to improve fetal brain development in growth-restricted pregnancies
Fetal Brain Care: Therapies for Brain Neurodevelopment in Fetal Growth Restriction
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 304 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Institut d'Investigacions Biomèdiques August Pi i Sunyer Academic / other |
| Locations | 6 sites (Barcelona and 5 other locations) |
| Trial ID | NCT05038462 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Barcelona and 5 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.