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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
304
The intervention consists in the maternal oral administration of 1000mg of Lactoferrin and 1000mg of DHA daily
Product with the same physical appearance and taste as the main intervention but without therapeutic effect
Hospital Clínic de Barcelona
Barcelona, Spain
RECRUITINGHospital de la Santa Creu i Sant Pau
Barcelona, Spain
RECRUITINGHospital del Mar
Barcelona, Spain
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 age
Cortical development
Assessed by fetal brain magnetic resonance imaging.
Time frame: 34 weeks of gestation
Fetal brain volume
Assessed by fetal brain magnetic resonance imaging.
Time frame: 34 weeks of gestation
Corpus callosum area
Assessed by fetal neurosonography.
Time frame: Enrolment, 32 and 36 weeks of gestation
Neonatal weight
Birth weight
Time frame: Delivery
Perinatal morbidity and mortality
Development of one of the following conditions: pregnancy complications, perinatal mortality, metabolic acidosis and major neonatal morbidity.
Time frame: Perinatal period: period ranging from 32 weeks of gestation (154 days) to the end of the first 4 weeks of neonatal life (28 days)
Postnatal neurodevelopmental assessment
Neurodevelopmental assessment using the Bayley III scale at 6 and 24 months of corrected postnatal age, as described in the primary outcome. A complementary neurodevelopmental assessment will be carried out in collaboration with the Speech Acquisition and Perception Groups of the University Pompeu Fabra Barcelona.
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Hospital Dexeus-Quirón
Barcelona, Spain
RECRUITINGHospital Sant Joan de Déu
Esplugues de Llobregat, Spain
RECRUITINGHospital General del Hospitalet
L'Hospitalet de Llobregat, Spain
RECRUITINGTime frame: Between 4 and 24 months of corrected postnatal age
Occurrence of adverse effects
Record of side effects that may appear. Since intervention is usually well tolerated, we do not expect major side effects.
Time frame: Through intervention (supplementation) completion, from enrolment to delivery