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

Fetal Growth Retardation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05038462
• Other study ID #: Fetal Brain Care
• Status: Recruiting
• Phase: N/A
• Start date: January 18, 2023
• Est. completion date: December 2026

Study information

• Verified date: March 2024
• Source: Institut d'Investigacions Biomèdiques August Pi i Sunyer
• Contact: Elisenda Eixarch, MD; PhD
• Phone: 0034 932279333
• Email: eixarch[@]clinic.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 304
• Est. completion date: December 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fetal Growth Retardation
• Intrauterine Growth Restriction

Intervention

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

Locations

Country	Name	City	State
Spain	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	Hospitalet de Llobregat

Sponsors (3)

Lead Sponsor	Collaborator
Institut d'Investigacions Biomèdiques August Pi i Sunyer	Fundació Sant Joan de Déu, Fundacion Clinic per a la Recerca Biomédica

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cortical development	Assessed by fetal brain magnetic resonance imaging.	34 weeks of gestation
Secondary	Fetal brain volume	Assessed by fetal brain magnetic resonance imaging.	34 weeks of gestation
Secondary	Corpus callosum area	Assessed by fetal neurosonography.	Enrolment, 32 and 36 weeks of gestation
Secondary	Neonatal weight	Birth weight	Delivery
Secondary	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)
Secondary	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
Secondary	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

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