An interventional study of Lactoferrin and DHA and Placebo in Fetal Growth Retardation and Intrauterine Growth Restriction, sponsored by Institut d'Investigacions Biomèdiques August Pi i Sunyer. Recruiting at 6 sites in Spain. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-18.
Sponsored by Institut d'Investigacions Biomèdiques August Pi i Sunyer · Not applicable, Interventional, and Prevention
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.
264 studies on the registry are indexed under Fetal Growth Retardation; 66 are open to participants now.
This study's planned enrollment of 304 is above the median of 101 across 117 interventional studies indexed under Fetal Growth Retardation.
Browse Fetal Growth Retardation studies →Institut d'Investigacions Biomèdiques August Pi i Sunyer is the lead sponsor of 9 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The intervention consists in the maternal oral administration of 1000mg of Lactoferrin and 1000mg of DHA daily
Dietary Supplement: Lactoferrin and DHA
Product with the same physical appearance and taste as the main intervention but without therapeutic effect
Other: Placebo
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
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.
Time 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
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Institut d'Investigacions Biomèdiques August Pi i Sunyer