Impact of Antioxidant Juice Intake on Brain Injury and Placental Pathology in Infants With Intrauterine Growth Restriction (IUGR)

NCT04394910 | Completed DMC

• 1 other identifier: 2014P000870
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intrauterine Growth Restriction

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• 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 Outcomes (2)

• Cognitive, motor, and language neurodevelopment scores on the Bayley III exam.

  The Bayley III exam will be administered at a one-time visit scheduled between 18-36 months.

• Maternal compliance with juice regimen.

  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.

Other Outcomes (5)

• Placental weight.

  The placenta will be weighed as part of routine pathology exam within 1-3 days of delivery.

• Incidence of pre-eclampsia.

  The electronic medical record will be reviewed within 1 week of delivery.

• Gestational age at delivery.

  The electronic medical record will be reviewed within 1 week of delivery.

Study Arms (2)

Pomegranate Juice

EXPERIMENTAL

Dietary supplementation with 8 oz. commercially-available pomegranate juice consumed daily.

Dietary Supplement: Pomegranate Juice

Placebo Juice

PLACEBO COMPARATOR

Dietary supplementation with 8 oz. placebo juice (identical to pomegranate juice but lacking polyphenols) consumed daily.

Dietary Supplement: Placebo Juice

Interventions

Pomegranate Juice DIETARY_SUPPLEMENT

Pomegranate Juice

Placebo Juice DIETARY_SUPPLEMENT

Placebo Juice

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- Expecting mother with a fetal diagnosis of less than 5th percentile on the Doubilet fetal growth curve

You may not qualify if:

• Multiple congenital abnormalities
• Known fetal chromosomal disorder
• Maternal illicit drug or alcohol intake

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• University of California, Los Angeles: collaborator
• POM Wonderful LLC: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• Ross MM, Cherkerzian S, Mikulis ND, Turner D, Robinson J, Inder TE, Matthews LG. A randomized controlled trial investigating the impact of maternal dietary supplementation with pomegranate juice on brain injury in infants with IUGR. Sci Rep. 2021 Feb 11;11(1):3569. doi: 10.1038/s41598-021-82144-0.

  PMID: 33574371 DERIVED

MeSH Terms

Conditions

Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Terrie E Inder, MD, MBChB

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Department of Pediatric Newborn Medicine

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: May 20, 2020
• Study Start: January 16, 2016
• Primary Completion: January 1, 2022
• Study Completion: February 26, 2022
• Last Updated: July 6, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)