RecruitingNot ApplicableNCT05038462

Fetal Brain Care: Therapies for Brain Neurodevelopment in Fetal Growth Restriction


Sponsor

Institut d'Investigacions Biomèdiques August Pi i Sunyer

Enrollment

304 participants

Start Date

Jan 18, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria4

  • Singleton pregnancies
  • Non-malformed fetus
  • Pregnancies with fetal growth restriction
  • weeks of gestation

Exclusion Criteria4

  • 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

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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


Locations(6)

Hospital Clínic de Barcelona

Barcelona, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Hospital del Mar

Barcelona, Spain

Hospital Dexeus-Quirón

Barcelona, Spain

Hospital Sant Joan de Déu

Esplugues de Llobregat, Spain

Hospital General del Hospitalet

L'Hospitalet de Llobregat, Spain

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NCT05038462


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