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Clinical Trials in Spain / NCT05038462
Recruiting Not applicable

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

NCT05038462 · tracked via the Priya Life Science Spain tracker
Sponsor
Institut d'Investigacions Biomèdiques August Pi i Sunyer
Phase
Not applicable
Started
2023-01-18
Last updated
2024-03-18

Condition(s) studied

Fetal Growth RetardationIntrauterine Growth Restriction

Investigational drug(s) / intervention(s)

Lactoferrin and DHAPlacebo

Lactoferrin and DHA: 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

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Bayley III scale at 24 months of age — 24 months of corrected postnatal age
    Bayley III scale is and individually administered instrument that assesses infant development across five domains, including cognitive, language and motor competencies. Parent reported questionnaires are incorporated to assess social-emotional and adaptative behaviors.

Trial sites (6)

FacilityCityRegionStatus
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

More Institut d'Investigacions Biomèdiques August Pi i Sunyer trials in Spain

Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes Starting soon

Other trials for the same condition

Selective Fetal Growth Restriction in Monochorionic Twins - an International Investigation Recruiting
sFlt1/PlGF and Planned Delivery to Prevent Preeclampsia at Term. Recruiting
Management of Early-onset Fetal Growth Restriction: Angiogenic Factors Versus Feto-placental Doppler Starting soon
MRI Assessment of Placental Health Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05038462 on ClinicalTrials.gov ↗ ← All trials in Spain