Fetal Growth RetardationNCT05038462
Fetal Brain Care: Therapies for Brain Neurodevelopment in Fetal Growth Restriction
A study testing Lactoferrin and DHA in people with Fetal Growth Retardation and Intrauterine Growth Restriction, run by Institut d'Investigacions Biomèdiques August Pi i Sunyer at 6 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fetal Growth Retardation, Intrauterine Growth Restriction
- What is being tested?
- Lactoferrin and DHA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 304 participants
- Where
- 6 sitesSpain
- Study dates
- 18 Jan 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Singleton pregnancies
- Non-malformed fetus
- Pregnancies with fetal growth restriction
- 24-32.6 weeks of gestation
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Spain6 sites, 6 recruiting
- Recruiting
Hospital Clínic de Barcelona
Barcelona
Elisenda Eixarch, eixarch@clinic.cat
Elena Monterde
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona
Pablo García-Manau
- Recruiting
Hospital del Mar
Barcelona
Elena Ferriols
- Recruiting
Hospital Dexeus-Quirón
Barcelona
Gerard Albaigés
- Recruiting
Hospital Sant Joan de Déu
Esplugues de Llobregat
Míriam Illa, milla@sjdhospitalbarcelona.org
- Recruiting
Hospital General del Hospitalet
L'Hospitalet de Llobregat
Susana Fernández
About this study
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.
Read the 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.
- Being tested
- Lactoferrin and DHA, Placebo
- Keywords
- Fetal Growth Retardation, Fetal Growth Restriction, Intrauterine Growth Restriction, Neurodevelopment, Lactoferrin, DHA
- Medical subject headings
- Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactoferrin and DHADietary supplement
The intervention consists in the maternal oral administration of 1000mg of Lactoferrin and 1000mg of DHA daily
PlaceboOther
Product with the same physical appearance and taste as the main intervention but without therapeutic effect
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Lactoferrin and DHA |
| Placebo | Placebo comparator | Product with the same physical appearance and taste as the main intervention but without therapeutic effect Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months of corrected postnatal age
Secondary outcomes (7)
Cortical development
Assessed by fetal brain magnetic resonance imaging.
Measured: 34 weeks of gestation
Fetal brain volume
Assessed by fetal brain magnetic resonance imaging.
Measured: 34 weeks of gestation
Corpus callosum area
Assessed by fetal neurosonography.
Measured: Enrolment, 32 and 36 weeks of gestation
Neonatal weight
Birth weight
Measured: Delivery
Perinatal morbidity and mortality
Development of one of the following conditions: pregnancy complications, perinatal mortality, metabolic acidosis and major neonatal morbidity.
Measured: 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.
Measured: 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.
Measured: Through intervention (supplementation) completion, from enrolment to delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2021
- Study start18 Jan 2023
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Growth RetardationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 304 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut d'Investigacions Biomèdiques August Pi i Sunyer
- Sponsor type
- University, hospital or other
- Collaborators
- Fundacion Clinic per a la Recerca Biomédica, Fundació Sant Joan de Déu
- Responsible party
- Principal investigator, Elisenda Eixarch Roca, Institut d'Investigacions Biomèdiques August Pi i Sunyer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05038462
- Sponsor's protocol ID
- Fetal Brain Care
- Status last verified
- Mar 2024
- First submitted
- 2 Aug 2021
- Last updated
- 18 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Brain Care: Therapies for Brain Neurodevelopment in Fetal Growth Restriction
- ClinicalTrials.gov ID
- NCT05038462
- Acronym / sponsor ID
- Fetal Brain Care
- Keywords
- Fetal Growth Retardation, Fetal Growth Restriction, Intrauterine Growth Restriction, Neurodevelopment, Lactoferrin, DHA
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 304 participants (estimated)
- Lead sponsor
- Institut d'Investigacions Biomèdiques August Pi i SunyerUniversity, hospital or other
- Collaborators
- Fundacion Clinic per a la Recerca Biomédica, Fundació Sant Joan de Déu
- Study start
- 18 Jan 2023 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 9 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maternal supplementation with Lactoferrin and DHA | Active comparator | Dietary Supplement: Lactoferrin and DHAThe intervention consists in the maternal oral administration of 1000mg of Lactoferrin and 1000mg of DHA daily |
| Placebo | Placebo comparator | Other: PlaceboProduct with the same physical appearance and taste as the main intervention but without therapeutic effect |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Singleton pregnancies
- Non-malformed fetus
- Pregnancies with fetal growth restriction
- 24-32.6 weeks of gestation
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactoferrin and DHAThe intervention consists in the maternal oral administration of 1000mg of Lactoferrin and 1000mg of DHA daily | Dietary supplement | Maternal supplementation with Lactoferrin and DHA |
| PlaceboProduct with the same physical appearance and taste as the main intervention but without therapeutic effect | Other | Placebo |
Primary outcome
Bayley III scale at 24 months of age
Time frame: 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.
7 secondary outcomes
Cortical development
Time frame: 34 weeks of gestation
Fetal brain volume
Time frame: 34 weeks of gestation
Corpus callosum area
Time frame: Enrolment, 32 and 36 weeks of gestation
Neonatal weight
Time frame: Delivery
Perinatal morbidity and mortality
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)
Postnatal neurodevelopmental assessment
Time frame: Between 4 and 24 months of corrected postnatal age
Occurrence of adverse effects
Time frame: Through intervention (supplementation) completion, from enrolment to delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactoferrin and DHA in people with Fetal Growth Retardation and Intrauterine Growth Restriction, run by Institut d'Investigacions Biomèdiques August Pi i Sunyer at 6 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elisenda Eixarch, MD; PhD (0034 932279333, eixarch@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bayley III scale at 24 months of age (time frame: 24 months of corrected postnatal age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.