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

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Fetal Growth Retardation, Intrauterine Growth Restriction

In brief

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.

Key facts

Study ID

NCT05038462

Run by

Institut d'Investigacions Biomèdiques August Pi i Sunyer

People needed

304

Starts

2023-01-18

Expected to finish

2026-12-01

Last updated by the study team

2024-03-18

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Singleton pregnancies
• Non-malformed fetus
• Pregnancies with fetal growth restriction
• 24-32.6 weeks of gestation

You may not qualify if…

• 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 is running

• Hospital Clínic de Barcelona — Barcelona, Spain (enrolling)
• Hospital de la Santa Creu i Sant Pau — Barcelona, Spain (enrolling)
• Hospital del Mar — Barcelona, Spain (enrolling)
• Hospital Dexeus-Quirón — Barcelona, Spain (enrolling)
• Hospital Sant Joan de Déu — Esplugues de Llobregat, Spain (enrolling)
• Hospital General del Hospitalet — L'Hospitalet de Llobregat, Spain (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.