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

NCT04394910 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2023-07-06

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Pomegranate Juice

DIETARY_SUPPLEMENT

Placebo Juice

Sponsors & Collaborators

Principal Investigators

  • Terrie E Inder, MD, MBChB · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-16
Primary Completion
2022-01-01
Completion
2022-02-26

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04394910 on ClinicalTrials.gov