NCT05038462

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
304

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Jan 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Jan 2023Dec 2026

First Submitted

Initial submission to the registry

August 2, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 9, 2021

Completed
1.4 years until next milestone

Study Start

First participant enrolled

January 18, 2023

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

March 18, 2024

Status Verified

March 1, 2024

Enrollment Period

3.6 years

First QC Date

August 2, 2021

Last Update Submit

March 15, 2024

Conditions

Fetal Growth RetardationIntrauterine Growth Restriction

Keywords

Fetal Growth RetardationFetal Growth RestrictionIntrauterine Growth RestrictionNeurodevelopmentLactoferrinDHA

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Cortical development

    34 weeks of gestation

  • Fetal brain volume

    34 weeks of gestation

  • Corpus callosum area

    Enrolment, 32 and 36 weeks of gestation

  • Neonatal weight

    Delivery

  • 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)

  • +2 more secondary outcomes

Study Arms (2)

Maternal supplementation with Lactoferrin and DHA

ACTIVE COMPARATOR

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

Dietary Supplement: Lactoferrin and DHA

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Lactoferrin and DHADIETARY_SUPPLEMENT

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

Maternal supplementation with Lactoferrin and DHA
PlaceboOTHER

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

Placebo

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Singleton pregnancies
  • Non-malformed fetus
  • Pregnancies with fetal growth restriction
  • weeks of gestation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Hospital Clínic de Barcelona

Barcelona, Spain

RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

RECRUITING

Hospital del Mar

Barcelona, Spain

RECRUITING

Hospital Dexeus-Quirón

Barcelona, Spain

RECRUITING

Hospital Sant Joan de Déu

Esplugues de Llobregat, Spain

RECRUITING

Hospital General del Hospitalet

L'Hospitalet de Llobregat, Spain

RECRUITING

Related Links

MeSH Terms

Conditions

Fetal Growth Retardation

Interventions

Lactoferrin

Condition Hierarchy (Ancestors)

Fetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGrowth DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Serine EndopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesSerine ProteasesGlycoproteinsGlycoconjugatesCarbohydratesTransferrinsIron-Binding ProteinsCarrier ProteinsProteinsAmino Acids, Peptides, and ProteinsLactoglobulinsWhey ProteinsMilk ProteinsAnimal Proteins, DietaryDietary ProteinsGlobulinsMetalloproteins

Central Study Contacts

Elisenda Eixarch, MD; PhD

CONTACT

0034 932279333eixarch@clinic.cat

Elena Monterde, MD

CONTACT

0034 932279333monterde@clinic.cat

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Coordinator of Fetal Neurology Unit

Study Record Dates

First Submitted

August 2, 2021

First Posted

September 9, 2021

Study Start

January 18, 2023

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

March 18, 2024

Record last verified: 2024-03

Locations

ES(6)