- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04394910
Impact of Antioxidant Juice Intake on Brain Injury and Placental Pathology in Infants With Intrauterine Growth Restriction (IUGR)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The current study seeks to investigate the impact of maternal dietary supplementation with pomegranate juice on placental morphology and on subsequent newborn brain development and function. A total of 99 consenting women carrying fetuses with a diagnosis of intrauterine growth restriction (IUGR) in the third trimester were randomized to one of two arms.
Treatment Group: Expecting mothers in this group will be randomized to consume 8oz of pomegranate juice daily. Participants will keep a daily diary documenting compliance with the regimen. Participants will continue daily intake until delivery.
Placebo group: Expecting mothers will be randomized to consume an 8oz of pomegranate free juice placebo that matches taste, calories, and appearance to regular pomegranate juice but lacks polyphenols. Participants will keep a diary of daily intake to help ensure compliance similar to the treatment group. Participants will continue to placebo until delivery.
Both groups: Maternal blood and urine samples will be collected prior to starting the juice regimen in order to establish baseline metabolite status. For the first 84 mothers enrolled, a fetal MRI was scheduled prior to beginning the juice regimen. Phase I participants will undergo two fetal echocardiograms: one before starting the juice regimen, and a second two weeks into the juice regimen to establish the safety of high polyphenol intake on fetal heart development. All women will be contacted on a weekly basis to assess compliance. At the time of delivery, maternal blood and urine, and cord blood will be collected and sent for analysis to test for the presence of dimethylellagic acid glucuronide (DMEAG) and urolithin A glucuronide (UAG), polyphenic components of pomegranate juice. Placental material will be sent for formal pathological exam.
If clinically stable, MRI will be undertaken without sedation at term equivalent (38-41 weeks CGA). Infants will undergo testing of cognitive, gross and fine motor, and speech skills at around 2 years of age.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Brigham and Women's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pomegranate Juice
Dietary supplementation with 8 oz.
commercially-available pomegranate juice consumed daily.
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|
Placebo Comparator: Placebo Juice
Dietary supplementation with 8 oz.
placebo juice (identical to pomegranate juice but lacking polyphenols) consumed daily.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Infant brain injury assessed on term-equivalent brain magnetic resonance image (MRI) using the Kidokoro injury scoring system.
Time Frame: One time occurrence at birth or term-equivalent age if infant is born preterm.
|
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.
|
Total and regional infant brain volumes assessed on term equivalent brain MRI using MANTiS.
Time Frame: One time occurrence at birth or term-equivalent age if infant is born preterm.
|
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.
|
Diffusion tensor imaging measures of fractional anisotropy (FA), and mean (MD), radial (RD), and axial (AD) diffusivity from infant term equivalent brain MRI.
Time Frame: One time occurrence at birth or term-equivalent age if infant is born preterm.
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FA, MD, RD, and AD will be measured from a diffusion-weighted sequence on brain MRI.
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One time occurrence at birth or term-equivalent age if infant is born preterm.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive, motor, and language neurodevelopment scores on the Bayley III exam.
Time Frame: The Bayley III exam will be administered at a one-time visit scheduled between 18-36 months.
|
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.
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The Bayley III exam will be administered at a one-time visit scheduled between 18-36 months.
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Maternal compliance with juice regimen.
Time Frame: 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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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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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Placental weight.
Time Frame: The placenta will be weighed as part of routine pathology exam within 1-3 days of delivery.
|
Weight of the placenta measured in grams.
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The placenta will be weighed as part of routine pathology exam within 1-3 days of delivery.
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Incidence of pre-eclampsia.
Time Frame: The electronic medical record will be reviewed within 1 week of delivery.
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Incidence of pre-eclampsia requiring medication as documented in the medical record.
|
The electronic medical record will be reviewed within 1 week of delivery.
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Gestational age at delivery.
Time Frame: The electronic medical record will be reviewed within 1 week of 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.
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Incidence of resuscitation at delivery.
Time Frame: The electronic medical record will be reviewed within 1 week of delivery.
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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.
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Cord gas characteristics.
Time Frame: The electronic medical record will be reviewed within 1 week of delivery.
|
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.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Terrie E Inder, MD, MBChB, Brigham and Women's Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Wounds and Injuries
- Craniocerebral Trauma
- Trauma, Nervous System
- Fetal Diseases
- Pregnancy Complications
- Growth Disorders
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Brain Injuries
- Fetal Growth Retardation
Other Study ID Numbers
- 2014P000870
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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