Actively Recruiting
Fetal Brain Care: Therapies for Brain Neurodevelopment in Fetal Growth Restriction
Led by Institut d'Investigacions Biomèdiques August Pi i Sunyer · Updated on 2024-03-18
304
Participants Needed
6
Research Sites
201 weeks
Total Duration
On this page
Sponsors
I
Institut d'Investigacions Biomèdiques August Pi i Sunyer
Lead Sponsor
F
Fundacion Clinic per a la Recerca Biomédica
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Fetal Brain Care: Therapies for Brain Neurodevelopment in Fetal Growth Restriction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Singleton pregnancies
- Non-malformed fetus
- Pregnancies diagnosed with fetal growth restriction
- Gestational age between 24 and 32.6 weeks
You will not qualify if you...
- Chromosomal or structural abnormalities diagnosed during pregnancy or neonatal period
- Critical Doppler findings suggesting delivery needed within 14 days (reverse end-diastolic velocity in umbilical artery or ductus venosus pulsatility >95th centile)
- Maternal mental or psychiatric disorders
- Maternal allergy to cow's milk protein
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Hospital Clínic de Barcelona
Barcelona, Spain
Actively Recruiting
2
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Actively Recruiting
3
Hospital del Mar
Barcelona, Spain
Actively Recruiting
4
Hospital Dexeus-Quirón
Barcelona, Spain
Actively Recruiting
5
Hospital Sant Joan de Déu
Esplugues de Llobregat, Spain
Actively Recruiting
6
Hospital General del Hospitalet
L'Hospitalet de Llobregat, Spain
Actively Recruiting
Research Team
E
Elisenda Eixarch, MD; PhD
CONTACT
E
Elena Monterde, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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