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

Not Applicable

Recruiting

• Conditions: Fetal Growth Retardation; Intrauterine Growth Restriction
• Interventions: Other: Placebo; Dietary Supplement: Lactoferrin and DHA

• Registration Number: NCT05038462
• Lead Sponsor: Institut d'Investigacions Biomèdiques August Pi i Sunyer

Brief 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.

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 Timeline

• Study First Submitted: 2021-08-02
• Study First Submitted QC: 2021-09-03
• Study First Posted: 2021-09-09
• Study Start: 2023-01-18
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-15
• Last Update Posted: 2024-03-18
• Primary Completion: 2026-09
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 304

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Product with the same physical appearance and taste as the main intervention but without therapeutic effect
Maternal supplementation with Lactoferrin and DHA	Lactoferrin and DHA	The intervention consists in the maternal oral administration of 1000mg of Lactoferrin and 1000mg of DHA daily

Primary Outcome Measures

Name	Time	Method
Bayley III scale at 24 months of age	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 Outcome Measures

Name	Time	Method
Fetal brain volume	34 weeks of gestation	Assessed by fetal brain magnetic resonance imaging.
Neonatal weight	Delivery	Birth weight
Corpus callosum area	Enrolment, 32 and 36 weeks of gestation	Assessed by fetal neurosonography.
Perinatal morbidity and mortality	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.
Cortical development	34 weeks of gestation	Assessed by fetal brain magnetic resonance imaging.
Postnatal neurodevelopmental assessment	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.
Occurrence of adverse effects	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.

Trial Locations

Locations (6)

Hospital Dexeus-Quirón; 🇪🇸 Barcelona, Spain

Hospital Clínic de Barcelona; 🇪🇸 Barcelona, Spain

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain

Hospital del Mar; 🇪🇸 Barcelona, Spain

Hospital Sant Joan de Déu; 🇪🇸 Esplugues De Llobregat, Spain

Hospital General del Hospitalet; 🇪🇸 Hospitalet de Llobregat, Spain