Fetal Brain Care: Therapies for Brain Neurodevelopment in Fetal Growth Restriction
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Fetal Growth Retardation
- Sponsor
- Institut d'Investigacions Biomèdiques August Pi i Sunyer
- Enrollment
- 304
- Locations
- 6
- Primary Endpoint
- Bayley III scale at 24 months of age
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
Randomized controlled trial among pregnant women that have been diagnosed of fetal growth restriction. These women will be randomized in order to evaluate the impact of maternal supplementation with Lactoferrin and DHA on the neurodevelopment outcome of their babies. Main hypothesis: a prenatal intervention based on maternal supplementation with Lactoferrin and DHA improves neurodevelopment in fetal growth restriction. Secondary hypothesis are that a prenatal intervention based on maternal supplementation with Lactoferrin and DHA in fetal growth restriction improves fetal growth and improves perinatal morbidity and mortality.
Investigators
Elisenda Eixarch Roca
Coordinator of Fetal Neurology Unit
Institut d'Investigacions Biomèdiques August Pi i Sunyer
Eligibility Criteria
Inclusion Criteria
- •Singleton pregnancies
- •Non-malformed fetus
- •Pregnancies with fetal growth restriction
- •24-32.6 weeks of gestation
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Bayley III scale at 24 months of age
Time Frame: 24 months of corrected postnatal 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.
Secondary Outcomes
- Neonatal weight(Delivery)
- Fetal brain volume(34 weeks of gestation)
- Corpus callosum area(Enrolment, 32 and 36 weeks of gestation)
- Perinatal morbidity and mortality(Perinatal period: period ranging from 32 weeks of gestation (154 days) to the end of the first 4 weeks of neonatal life (28 days))
- Cortical development(34 weeks of gestation)
- Postnatal neurodevelopmental assessment(Between 4 and 24 months of corrected postnatal age)
- Occurrence of adverse effects(Through intervention (supplementation) completion, from enrolment to delivery)