Impact of Antioxidant Juice Intake on Brain Injury and Placental Pathology in Infants With Intrauterine Growth Restriction (IUGR)
Condition: Intrauterine Growth Restriction
MeSH terms: Brain Injuries; Fetal Growth Retardation
Study type: Interventional

Summary: 
      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.
    

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.
    

Intervention name(s): Pomegranate Juice; Placebo Juice
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention