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| Name | Class |
|---|---|
| Fundacion Clinic per a la Recerca Biomédica | OTHER |
| Fundació Sant Joan de Déu | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Placebo | Placebo Comparator | Product with the same physical appearance and taste as the main intervention but without therapeutic effect |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactoferrin and DHA | Dietary Supplement | The intervention consists in the maternal oral administration of 1000mg of Lactoferrin and 1000mg of DHA daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cortical development | Assessed by fetal brain magnetic resonance imaging. | 34 weeks of gestation |
| Fetal brain volume | Assessed by fetal brain magnetic resonance imaging. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elisenda Eixarch, MD; PhD | Contact | 0034 932279333 | eixarch@clinic.cat | |
| Elena Monterde, MD | Contact | 0034 932279333 | monterde@clinic.cat |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clínic de Barcelona | Recruiting | Barcelona | Spain |
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| Label | URL |
|---|---|
| Related Info | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 11, 2022 | Dec 19, 2022 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 7, 2022 | Dec 12, 2022 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D005317 | Fetal Growth Retardation |
| ID | Term |
|---|---|
| D005315 | Fetal Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D007781 | Lactoferrin |
| ID | Term |
|---|---|
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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| Placebo | Other | Product with the same physical appearance and taste as the main intervention but without therapeutic effect |
|
| 34 weeks of gestation |
| Corpus callosum area | Assessed by fetal neurosonography. | Enrolment, 32 and 36 weeks of gestation |
| Neonatal weight | Birth weight | Delivery |
| 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) |
| 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 |
| 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 |
| Hospital de la Santa Creu i Sant Pau | Recruiting | Barcelona | Spain |
|
| Hospital del Mar | Recruiting | Barcelona | Spain |
|
| Hospital Dexeus-Quirón | Recruiting | Barcelona | Spain |
|
| Hospital Sant Joan de Déu | Recruiting | Esplugues de Llobregat | Spain |
|
| Hospital General del Hospitalet | Recruiting | L'Hospitalet de Llobregat | Spain |
|
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006130 | Growth Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D061250 | Transferrins |
| D033862 | Iron-Binding Proteins |
| D002352 | Carrier Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007782 | Lactoglobulins |
| D000067816 | Whey Proteins |
| D008894 | Milk Proteins |
| D000080224 | Animal Proteins, Dietary |
| D004044 | Dietary Proteins |
| D005916 | Globulins |
| D008667 | Metalloproteins |