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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Lactoferrin and DHA
Dietary supplementThe intervention consists in the maternal oral administration of 1000mg of Lactoferrin and 1000mg of DHA daily
Placebo
Other interventionProduct with the same physical appearance and taste as the main intervention but without therapeutic effect
Treatment groups
304 Participants
are divided into 2 treatment groupsGroup A: Maternal supplementation with Lactoferrin and DHAActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Bayley III scale at 24 months of 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.
Time frame
24 months of corrected postnatal ageSecondary outcomes
1
Cortical development
Assessed by fetal brain magnetic resonance imaging.
Time frame
34 weeks of gestation2
Fetal brain volume
Assessed by fetal brain magnetic resonance imaging.
Time frame
34 weeks of gestation3
Corpus callosum area
Assessed by fetal neurosonography.
Time frame
Enrolment, 32 and 36 weeks of gestation4
Neonatal weight
Birth weight
Time frame
DeliverySponsors and contacts
Click on the lead sponsor to view all of their trials.
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