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Fetal Brain Care: Therapies for Brain Neurodevelopment in Fetal Growth Restriction
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.
Details
| Lead sponsor | Institut d'Investigacions Biomèdiques August Pi i Sunyer |
|---|---|
| Phase | NA |
| Status | RECRUITING |
| Enrolment | 304 |
| Start date | 2023-01-18 |
| Completion | 2026-12 |
Conditions
- Fetal Growth Retardation
- Intrauterine Growth Restriction
Interventions
- Lactoferrin and DHA
- Placebo
Primary outcomes
- Bayley III scale at 24 months of age — 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.
Countries
Spain