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
13 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
This research aims to evaluate the effects of maternal supplementation with Lactoferrin and DHA on brain development in babies diagnosed with fetal growth restriction during pregnancy. Pregnant women carrying singleton pregnancies with fetal growth restriction between 24 and 32.6 weeks of gestation will be studied to see if this prenatal intervention improves neurodevelopment outcomes. Secondary goals include assessing improvements in fetal growth and reductions in perinatal complications. Participants will be randomly assigned to one of two groups: one receiving daily oral supplements of 1000mg Lactoferrin and 1000mg DHA, and the other receiving a placebo that looks and tastes the same but lacks active ingredients. The supplementation continues until delivery. This study uses a quadruple-masked design to ensure unbiased results. During the study, babies' neurodevelopment will be assessed using the Bayley III scale at 24 months corrected age. Researchers will also measure fetal brain development through scans at 32, 34, and 36 weeks of gestation, track neonatal weight at birth, and monitor perinatal health through the first four weeks after birth. Safety and any adverse effects during supplementation will be closely observed. The total participation time spans from diagnosis during pregnancy until two years after birth.
CONDITIONS
Brief 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 with fetal growth restriction
- Between 24 and 32.6 weeks of gestation
You will not qualify if you...
- Chromosomal or structural abnormalities diagnosed during pregnancy or in the neonatal period
- Critical Doppler study suggesting delivery within 14 days due to reverse end-diastolic velocity in the umbilical artery or ductus venosus pulsatility over 95th centile
- Maternal mental or psychiatric disorders
- Maternal allergy to cow's milk protein
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - From enrollment between 24 and 32.6 weeks of gestation until delivery
Participants take daily maternal oral supplements of Lactoferrin and DHA or placebo during pregnancy.
Visits at enrollment, 32 weeks, 34 weeks, and 36 weeks of gestation
Duration - From delivery up to 24 months of corrected postnatal age
Participants and their babies are assessed for neurodevelopment and health outcomes after birth.
Neurodevelopmental assessments between 4 and 24 months of age
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
E
Elena Monterde, MD
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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