Fetal Growth Retardation, Intrauterine Growth Restriction
Conditions
Keywords
Fetal Growth Retardation, Fetal Growth Restriction, Intrauterine Growth Restriction, Neurodevelopment, Lactoferrin, DHA
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.
Interventions
DIETARY_SUPPLEMENTLactoferrin and DHA
The intervention consists in the maternal oral administration of 1000mg of Lactoferrin and 1000mg of DHA daily
OTHERPlacebo
Product with the same physical appearance and taste as the main intervention but without therapeutic effect
Sponsors
Fundacion Clinic per a la Recerca Biomédica
Fundació Sant Joan de Déu
Institut d'Investigacions Biomèdiques August Pi i Sunyer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fetal brain volume | 34 weeks of gestation | Assessed by fetal brain magnetic resonance imaging. |
| Corpus callosum area | Enrolment, 32 and 36 weeks of gestation | Assessed by fetal neurosonography. |
| Neonatal weight | Delivery | Birth weight |
| Cortical development | 34 weeks of gestation | Assessed by fetal brain magnetic resonance imaging. |
| Postnatal neurodevelopmental assessment | Between 4 and 24 months of corrected postnatal age | 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. |
| Occurrence of adverse effects | Through intervention (supplementation) completion, from enrolment to delivery | Record of side effects that may appear. Since intervention is usually well tolerated, we do not expect major side effects. |
| 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) | Development of one of the following conditions: pregnancy complications, perinatal mortality, metabolic acidosis and major neonatal morbidity. |
Countries
Spain
Contacts
Primary ContactElisenda Eixarch, MD; PhD
Backup ContactElena Monterde, MD
Outcome results
None listed