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NCT Number: NCT05038462

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

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.

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Key information

Conditions

Fetal Growth Retardation Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Growth Disorders Intrauterine Growth Restriction Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clínic de Barcelona, Barcelona, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lactoferrin and DHA

Dietary Supplement

The intervention consists in the maternal oral administration of 1000mg of Lactoferrin and 1000mg of DHA daily

Placebo

Other

Product with the same physical appearance and taste as the main intervention but without therapeutic effect

Primary outcomes

  1. Bayley III scale at 24 months of age

    Time frame: 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 outcomes

  1. Cortical development

    Time frame: 34 weeks of gestation

    Assessed by fetal brain magnetic resonance imaging.

  2. Fetal brain volume

    Time frame: 34 weeks of gestation

    Assessed by fetal brain magnetic resonance imaging.

  3. Corpus callosum area

    Time frame: Enrolment, 32 and 36 weeks of gestation

    Assessed by fetal neurosonography.

  4. Neonatal weight

    Time frame: Delivery

    Birth weight

  5. 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)

    Development of one of the following conditions: pregnancy complications, perinatal mortality, metabolic acidosis and major neonatal morbidity.

  6. Postnatal neurodevelopmental assessment

    Time frame: 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.

  7. Occurrence of adverse effects

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Elena Monterde, MD

CONTACT

[email protected]

0034 932279333

Elisenda Eixarch, MD; PhD

CONTACT

[email protected]

0034 932279333

Sponsors and collaborators

Lead sponsor

Institut d'Investigacions Biomèdiques August Pi i Sunyer

Other

Collaborators

  • Fundacion Clinic per a la Recerca Biomédica
  • Fundació Sant Joan de Déu

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 9, 2021
Registry last updated
Mar 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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