Fetal Brain Care: Therapies for Brain Neurodevelopment in Fetal Growth Restriction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorInstitut d'Investigacions Biomèdiques August Pi i Sunyer
About this trial
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 criteria
Qualifiers
Singleton pregnancies
Non-malformed fetus
Pregnancies with fetal growth restriction
24-32.6 weeks of gestation
Disqualifiers
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
Trial design
Treatments tested in this trial
- Lactoferrin and DHA
- Placebo
Treatment groups
304 Participants
are divided into 2 treatment groupsSponsors and collaborators
Institut d'Investigacions Biomèdiques August Pi i Sunyer
Lead sponsor
Fundacion Clinic per a la Recerca Biomédica
Collaborator
Fundació Sant Joan de Déu
Collaborator
Source ClinicalTrials.gov