Fetal Brain Care: Therapies for Brain Neurodevelopment in Fetal Growth Restriction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lactoferrin and DHA, Placebo.
- Who it may be relevant to
- Registry conditions: Fetal Growth Retardation, Intrauterine Growth Restriction. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 supplement Lactoferrin and DHA
The intervention consists in the maternal oral administration of 1000mg of Lactoferrin and 1000mg of DHA daily - Other Placebo
Product with the same physical appearance and taste as the main intervention but without therapeutic effect
Primary outcome measures
- Bayley III scale at 24 months of age [Time frame: 24 months of corrected postnatal age]
Secondary outcome measures (7)
- Cortical development [Time frame: 34 weeks of gestation]
- Fetal brain volume [Time frame: 34 weeks of gestation]
- Corpus callosum area [Time frame: Enrolment, 32 and 36 weeks of gestation]
- Neonatal weight [Time frame: Delivery]
- Perinatal morbidity and mortality [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 [Time frame: Between 4 and 24 months of corrected postnatal age]
- Occurrence of adverse effects [Time frame: Through intervention (supplementation) completion, from enrolment to delivery]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Spain · 6 centers
- Hospital Clínic de Barcelona — Barcelona
- Hospital de la Santa Creu i Sant Pau — Barcelona
- Hospital del Mar — Barcelona
- Hospital Dexeus-Quirón — Barcelona
- Hospital Sant Joan de Déu — Esplugues de Llobregat
- Hospital General del Hospitalet — L'Hospitalet de Llobregat
Identifiers
NCT: NCT05038462 · Fetal Brain Care