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

Primary Purpose

Fetal Growth Retardation, Intrauterine Growth Restriction

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Lactoferrin and DHA
Placebo
Sponsored by
Institut d'Investigacions Biomèdiques August Pi i Sunyer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Fetal Growth Retardation focused on measuring Fetal Growth Retardation, Fetal Growth Restriction, Intrauterine Growth Restriction, Neurodevelopment, Lactoferrin, DHA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Germans Trias i Pujol
  • Hospital Clínic de BarcelonaRecruiting
  • Hospital de la Santa Creu i Sant Pau
  • Hospital del Mar
  • Hospital Dexeus-Quirón
  • Hospital Sant Joan de DéuRecruiting
  • Hospital General del Hospitalet

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Maternal supplementation with Lactoferrin and DHA

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Cortical development
Assessed by fetal brain magnetic resonance imaging.
Fetal brain volume
Assessed by fetal brain magnetic resonance imaging.
Corpus callosum area
Assessed by fetal neurosonography.
Neonatal weight
Birth weight
Perinatal morbidity and mortality
Development of one of the following conditions: pregnancy complications, perinatal mortality, metabolic acidosis and major neonatal morbidity.
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.
Occurrence of adverse effects
Record of side effects that may appear. Since intervention is usually well tolerated, we do not expect major side effects.

Full Information

First Posted
August 2, 2021
Last Updated
March 1, 2023
Sponsor
Institut d'Investigacions Biomèdiques August Pi i Sunyer
Collaborators
Fundacion Clinic per a la Recerca Biomédica, Fundació Sant Joan de Déu
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1. Study Identification

Unique Protocol Identification Number
NCT05038462
Brief Title
Fetal Brain Care: Therapies for Brain Neurodevelopment in Fetal Growth Restriction
Official Title
Fetal Brain Care: Therapies for Brain Neurodevelopment in Fetal Growth Restriction
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 18, 2023 (Actual)
Primary Completion Date
September 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut d'Investigacions Biomèdiques August Pi i Sunyer
Collaborators
Fundacion Clinic per a la Recerca Biomédica, Fundació Sant Joan de Déu

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Growth Retardation, Intrauterine Growth Restriction
Keywords
Fetal Growth Retardation, Fetal Growth Restriction, Intrauterine Growth Restriction, Neurodevelopment, Lactoferrin, DHA

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
304 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Maternal supplementation with Lactoferrin and DHA
Arm Type
Active Comparator
Arm Description
The intervention consists in the maternal oral administration of 1000mg of Lactoferrin and 1000mg of DHA daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Product with the same physical appearance and taste as the main intervention but without therapeutic effect
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactoferrin and DHA
Intervention Description
The intervention consists in the maternal oral administration of 1000mg of Lactoferrin and 1000mg of DHA daily
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Product with the same physical appearance and taste as the main intervention but without therapeutic effect
Primary Outcome Measure Information:
Title
Bayley III scale at 24 months of age
Description
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.
Time Frame
24 months of corrected postnatal age
Secondary Outcome Measure Information:
Title
Cortical development
Description
Assessed by fetal brain magnetic resonance imaging.
Time Frame
34 weeks of gestation
Title
Fetal brain volume
Description
Assessed by fetal brain magnetic resonance imaging.
Time Frame
34 weeks of gestation
Title
Corpus callosum area
Description
Assessed by fetal neurosonography.
Time Frame
Enrolment, 32 and 36 weeks of gestation
Title
Neonatal weight
Description
Birth weight
Time Frame
Delivery
Title
Perinatal morbidity and mortality
Description
Development of one of the following conditions: pregnancy complications, perinatal mortality, metabolic acidosis and major neonatal morbidity.
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)
Title
Postnatal neurodevelopmental assessment
Description
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.
Time Frame
Between 4 and 24 months of corrected postnatal age
Title
Occurrence of adverse effects
Description
Record of side effects that may appear. Since intervention is usually well tolerated, we do not expect major side effects.
Time Frame
Through intervention (supplementation) completion, from enrolment to delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elisenda Eixarch, MD; PhD
Phone
0034 932279333
Email
eixarch@clinic.cat
First Name & Middle Initial & Last Name or Official Title & Degree
Elena Monterde, MD
Phone
0034 932279333
Email
monterde@clinic.cat
Facility Information:
Facility Name
Hospital Germans Trias i Pujol
City
Badalona
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carmina Comas
Facility Name
Hospital Clínic de Barcelona
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisenda Eixarch
Email
eixarch@clinic.cat
First Name & Middle Initial & Last Name & Degree
Elena Monterde
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irene Ribera
Facility Name
Hospital del Mar
City
Barcelona
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Luis Hernández
Facility Name
Hospital Dexeus-Quirón
City
Barcelona
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gerard Albagies
Facility Name
Hospital Sant Joan de Déu
City
Esplugues De Llobregat
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Míriam Illa
Email
milla@sjdhospitalbarcelona.org
Facility Name
Hospital General del Hospitalet
City
Hospitalet de Llobregat
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susana Fernández

12. IPD Sharing Statement

Links:
URL
http://bcnatalresearch.org/en/projects/fetalbraincare/
Description
Related Info

Learn more about this trial

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

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