Impact of Antioxidant Juice Intake on Brain Injury and Placental Pathology in Infants With Intrauterine Growth Restriction (IUGR)
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|ClinicalTrials.gov Identifier: NCT04394910|
Recruitment Status : Active, not recruiting
First Posted : May 20, 2020
Last Update Posted : September 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|Intrauterine Growth Restriction||Dietary Supplement: Pomegranate Juice Dietary Supplement: Placebo Juice||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||103 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Impact of Antioxidant Juice Intake on Brain Injury and Placental Pathology in Infants With Intrauterine Growth Restriction (IUGR)|
|Actual Study Start Date :||January 16, 2016|
|Actual Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||December 2021|
Experimental: Pomegranate Juice
Dietary supplementation with 8 oz. commercially-available pomegranate juice consumed daily.
Dietary Supplement: Pomegranate Juice
Placebo Comparator: Placebo Juice
Dietary supplementation with 8 oz. placebo juice (identical to pomegranate juice but lacking polyphenols) consumed daily.
Dietary Supplement: Placebo Juice
- 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).
- 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).
- 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. ]FA, MD, RD, and AD will be measured from a diffusion-weighted sequence on brain MRI.
- 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.
- 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. ]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.
- 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.
- Incidence of pre-eclampsia. [ Time Frame: The electronic medical record will be reviewed within 1 week of delivery. ]Incidence of pre-eclampsia requiring medication as documented in the medical record.
- 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.
- Incidence of resuscitation at delivery. [ Time Frame: The electronic medical record will be reviewed within 1 week of delivery. ]Incidence of infant resuscitation at delivery measured by APGAR scores assigned at birth and documented in the medical record.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04394910
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Terrie E Inder, MD, MBChB||Brigham and Women's Hospital|