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

NCT05038462 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 304

Last updated 2024-03-18

No results posted yet for this study

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.

Conditions

  • Fetal Growth Retardation
  • Intrauterine Growth Restriction

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

Sponsors & Collaborators

  • Fundacion Clinic per a la Recerca Biomédica

    collaborator OTHER
  • Fundació Sant Joan de Déu

    collaborator OTHER
  • Institut d'Investigacions Biomèdiques August Pi i Sunyer

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-18
Primary Completion
2026-09-30
Completion
2026-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05038462 on ClinicalTrials.gov