Intrauterine Growth Restriction Clinical Trial
Official title:
Impact of Antioxidant Juice Intake on Brain Injury and Placental Pathology in Infants With Intrauterine Growth Restriction (IUGR)
Verified date | July 2023 |
Source | Brigham and Women's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Infants diagnosed with intrauterine growth restriction are at increased risk for brain injury in the neonatal period, and eventually increased risk for adverse long-term neurodevelopmental outcomes. This kind of growth restriction is often caused by long-term placental insufficiency leading to chronic lack of oxygen in the brain during development. Pomegranate juice is one of the highest polyphenol-containing dietary supplements commercially available. Previous studies have shown that pomegranate-derived polyphenols are potent neuroprotective antioxidants with no proven side effects. The investigators hypothesize that maternal dietary supplementation with pomegranate juice during the last trimester of pregnancy will reduce the effects of exogenous stimuli contributing to placental insufficiency, and will enhance brain growth and development in the IUGR population.
Status | Completed |
Enrollment | 103 |
Est. completion date | February 26, 2022 |
Est. primary completion date | January 1, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - Expecting mother with a fetal diagnosis of less than 5th percentile on the Doubilet fetal growth curve Exclusion Criteria: - Multiple congenital abnormalities - Known fetal chromosomal disorder - Maternal illicit drug or alcohol intake |
Country | Name | City | State |
---|---|---|---|
United States | Brigham and Women's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Brigham and Women's Hospital | POM Wonderful LLC, University of California, Los Angeles |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Placental weight. | Weight of the placenta measured in grams. | The placenta will be weighed as part of routine pathology exam within 1-3 days of delivery. | |
Other | Incidence of pre-eclampsia. | Incidence of pre-eclampsia requiring medication as documented in the medical record. | The electronic medical record will be reviewed within 1 week of delivery. | |
Other | Gestational age at delivery. | Gestational age at delivery based on ultrasound dating acquired at less than 12 weeks' gestation as documented in the medical record. | The electronic medical record will be reviewed within 1 week of delivery. | |
Other | Incidence of resuscitation at delivery. | Incidence of infant resuscitation at delivery measured by APGAR scores assigned at birth and documented in the medical record. | The electronic medical record will be reviewed within 1 week of delivery. | |
Other | Cord gas characteristics. | Umbilical artery cord gas pH and base deficit as documented in the medical record. | The electronic medical record will be reviewed within 1 week of delivery. | |
Primary | Infant brain injury assessed on term-equivalent brain magnetic resonance image (MRI) using the Kidokoro injury scoring system. | The Kidokoro scale is a comprehensive, objective scoring system for classifying the nature and extent of neonatal brain injury on MRI (Kidokoro et al. American Journal of Neuroradiology. 2013; 34(11):2208-14). | One time occurrence at birth or term-equivalent age if infant is born preterm. | |
Primary | Total and regional infant brain volumes assessed on term equivalent brain MRI using MANTiS. | MANTiS (Morphologically Adaptive Neonatal Tissue Segmentation) describes neonate-specific brain tissue segmentation into 8 categories using Statistical Parametric Mapping (SPM) software (Beare et al. Frontiers in Neuroinformatics. 2016;10:12). | One time occurrence at birth or term-equivalent age if infant is born preterm. | |
Primary | Diffusion tensor imaging measures of fractional anisotropy (FA), and mean (MD), radial (RD), and axial (AD) diffusivity from infant term equivalent brain MRI. | FA, MD, RD, and AD will be measured from a diffusion-weighted sequence on brain MRI. | One time occurrence at birth or term-equivalent age if infant is born preterm. | |
Secondary | Cognitive, motor, and language neurodevelopment scores on the Bayley III exam. | The Bayley Scores of Infant and Toddler Development (Edition III) is a comprehensive examination tool used to assess neurodevelopment in infants and toddlers up to 42 months. | The Bayley III exam will be administered at a one-time visit scheduled between 18-36 months. | |
Secondary | Maternal compliance with juice regimen. | Maternal compliance with the assigned juice regimen is assessed by participant logbook record and assessment of change in polyphenols (urolithin A and dimethylellagic glucuronide concentration, ng/mL) in maternal urine and blood at enrollment and in maternal urine, blood and cord blood at the time of delivery. | Comparison of one pre-juice regimen UA and DMEAG concentration measurement (ng/mL) to one post-juice regimen blood and urine concentration measurement (ng/mL) collected at the time of delivery. |
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