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.

Study Overview

• Status: Recruiting
• Conditions: Fetal Growth Retardation; Intrauterine Growth Restriction
• Intervention / Treatment: Dietary supplement: Lactoferrin and DHA; Other: 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.

• Study Type: Interventional
• Enrollment (Estimated): 304
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elisenda Eixarch, MD; PhD; Phone Number: 0034 932279333; Email: eixarch@clinic.cat
• Study Contact Backup: Name: Elena Monterde, MD; Phone Number: 0034 932279333; Email: monterde@clinic.cat

Study Locations

• Spain
  • Barcelona, Spain
    • Recruiting
    • Hospital Del Mar
    • Contact: Elena Ferriols
  • Barcelona, Spain
    • Recruiting
    • Hospital Clinic de Barcelona
    • Contact: Elisenda Eixarch; Email: eixarch@clinic.cat
    • Sub-Investigator: Elena Monterde
  • Barcelona, Spain
    • Recruiting
    • Hospital de la Santa Creu i Sant Pau
    • Contact: Pablo García-Manau
  • Barcelona, Spain
    • Recruiting
    • Hospital Dexeus-Quirón
    • Contact: Gerard Albaigés
  • Esplugues De Llobregat, Spain
    • Recruiting
    • Hospital Sant Joan de Deu
    • Contact: Míriam Illa; Email: milla@sjdhospitalbarcelona.org
  • Hospitalet de Llobregat, Spain
    • Recruiting
    • Hospital General del Hospitalet
    • Contact: Susana Fernández

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Maternal supplementation with Lactoferrin and DHA; The intervention consists in the maternal oral administration of 1000mg of Lactoferrin and 1000mg of DHA daily	Dietary supplement: Lactoferrin and DHA; The intervention consists in the maternal oral administration of 1000mg of Lactoferrin and 1000mg of DHA daily
Placebo Comparator: Placebo; Product with the same physical appearance and taste as the main intervention but without therapeutic effect	Other: Placebo; Product with the same physical appearance and taste as the main intervention but without therapeutic effect

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bayley III scale at 24 months of 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.	24 months of corrected postnatal age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cortical development	Assessed by fetal brain magnetic resonance imaging.	34 weeks of gestation
Fetal brain volume	Assessed by fetal brain magnetic resonance imaging.	34 weeks of gestation
Corpus callosum area	Assessed by fetal neurosonography.	Enrolment, 32 and 36 weeks of gestation
Neonatal weight	Birth weight	Delivery
Perinatal morbidity and mortality	Development of one of the following conditions: pregnancy complications, perinatal mortality, metabolic acidosis and major neonatal morbidity.	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	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.	Between 4 and 24 months of corrected postnatal age
Occurrence of adverse effects	Record of side effects that may appear. Since intervention is usually well tolerated, we do not expect major side effects.	Through intervention (supplementation) completion, from enrolment to delivery

Collaborators and Investigators

• Sponsor: Institut d'Investigacions Biomèdiques August Pi i Sunyer
• Collaborators: Fundacion Clinic per a la Recerca Biomédica; Fundació Sant Joan de Déu

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: August 2, 2021
• First Submitted That Met QC Criteria: September 3, 2021
• First Posted (Actual): September 9, 2021

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: DHA; Neurodevelopment; Lactoferrin; Intrauterine Growth Restriction; Fetal Growth Retardation; Fetal Growth Restriction
• Additional Relevant MeSH Terms: Pathologic Processes; Fetal Diseases; Pregnancy Complications; Growth Disorders; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Growth Retardation; Anti-Infective Agents; Lactoferrin
• Other Study ID Numbers: Fetal Brain Care

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No