Clinical trial NCT05038462: Fetal Brain Care: Therapies for Brain Neurodevelopment in Fetal Growth Restriction
Official title: Fetal Brain Care: Therapies for Brain Neurodevelopment in Fetal Growth Restriction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fetal Growth Retardation
Intrauterine Growth Restriction
Keywords: Fetal Growth Retardation
Fetal Growth Restriction
Intrauterine Growth Restriction
Neurodevelopment
Lactoferrin
DHA
Lead sponsor: Institut d'Investigacions Biomèdiques August Pi i Sunyer
Sponsor class: OTHER
Collaborators: name: Fundacion Clinic per a la Recerca Biomédica
name: Fundació Sant Joan de Déu
First posted: 2021-09-09
Enrollment: 304
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Bayley III scale at 24 months of age
timeFrame: 24 months of corrected postnatal age
Secondary outcomes:
measure: Cortical development
timeFrame: 34 weeks of gestation
measure: Fetal brain volume
timeFrame: 34 weeks of gestation
measure: Corpus callosum area
timeFrame: Enrolment, 32 and 36 weeks of gestation
measure: Neonatal weight
timeFrame: Delivery
measure: Perinatal morbidity and mortality
timeFrame: Perinatal period: period ranging from 32 weeks of gestation (154 days) to the end of the first 4 weeks of neonatal life (28 days)
measure: Postnatal neurodevelopmental assessment
timeFrame: Between 4 and 24 months of corrected postnatal age
measure: Occurrence of adverse effects
timeFrame: Through intervention (supplementation) completion, from enrolment to delivery
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Dexeus-Quirón
city: Esplugues De Llobregat
country: Spain
facility: Hospital Sant Joan de Déu
city: Hospitalet de Llobregat
country: Spain
facility: Hospital General del Hospitalet
Study officials:
References: