Trial record 6 of 54 for:    pomegranate

Impact of Maternal Pomegranate Juice on Brain Injury in Infants With Intrauterine Growth Restriction (IUGR) (POM-1)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Washington University School of Medicine.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00788866
First received: November 10, 2008
Last updated: August 3, 2011
Last verified: August 2011
  Purpose

Infants with intrauterine growth restriction are known to be at increased risk for long term neurodevelopmental delay into adulthood. The main mechanism for this is likely decreased blood flow to the brain secondary to altered placental blood flow. Antioxidants may serve to protect the developing brain from this process. Animal studies have shown that pomegranate juice protects the fetal brain from injury in a model of stroke. This clinical trial is intended to evaluate if giving mothers pomegranate juice during the last several weeks of pregnancy can help protect intrauterine growth restricted babies' brains.


Condition Intervention
Intrauterine Growth Restriction
Dietary Supplement: Pomegranate Juice
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Impact of Maternal Pomegranate Juice on Brain Injury in Infants With Intrauterine Growth Restriction (IUGR)

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • CNS injury at term by MR Imaging [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Neurodevelopmental delay at 18-24 months MDI and PDI by Bayley Scale of Infant Development (BSID III) (> 2SD from the norm, score ≤ 70) [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Placental weight [ Time Frame: To discharge ] [ Designated as safety issue: No ]
  • Gestation [ Time Frame: To discharge ] [ Designated as safety issue: No ]
  • Birth weight [ Time Frame: To discharge ] [ Designated as safety issue: No ]
  • Ellagic acid levels from cord blood [ Time Frame: To discharge ] [ Designated as safety issue: No ]
  • Dubowitz neurologic exam at term [ Time Frame: To discharge ] [ Designated as safety issue: No ]
  • Time to full oral feeds [ Time Frame: To discharge ] [ Designated as safety issue: No ]
  • ROP [ Time Frame: To discharge ] [ Designated as safety issue: No ]
  • NEC [ Time Frame: To discharge ] [ Designated as safety issue: No ]
  • Length of ventilatory support [ Time Frame: To discharge ] [ Designated as safety issue: No ]
  • Time to discharge [ Time Frame: To discharge ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: December 2008
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pomegranate juice
This arm with receive 8oz of pomegranate juice per day.
Dietary Supplement: Pomegranate Juice
8 oz of pomegranate juice daily vs placebo juice identical in all respects except pomegranate
Placebo Comparator: Placebo
This group will take 8oz of placebo juice that lacks pomegranate daily
Dietary Supplement: Placebo
Juice that matches the makeup of pomegranate in regards to sugar, vitamin C, etc. The only difference is that it lacks pomegranate juice.

Detailed Description:

This study will be divided into two separate phases.

Phase I will evaluate if the antioxidants produced from pomegranate juice cross the placenta in normal healthy pregnancies. Twenty woman will be enrolled, 10 who will take 8 oz of pomegranate juice daily and then 10 others who will take 8 oz of placebo juice without pomegranate daily. Blood samples will be first collected from the woman at the time enrollment and then from both the woman and the cord blood at the time of delivery. These blood samples will be analyzed to measure the levels of antioxidant metabolites from the pomegranate juice. This phase is deigned just to prove placental transfer of antioxidant pomegranate metabolites is possible.

Phase II will then focus on pregnancies with intrauterine growth restriction. If they meet entry criteria, then woman will be enrolled and randomized into 1 of 2 groups.

Treatment group: Expecting mothers in this group will start a daily regimen of 8 oz glass of pomegranate juice. They will keep a daily diary documenting their compliance. They will continue this daily intake up until delivery of their infant.

Placebo group: These women will start a daily regimen of an 8 oz of pomegranate free juice placebo that matches taste, calories, and appearance to regular pomegranate juice but lacks polyphenols. They will also keep a diary of daily intake to help ensure compliance similar to the treatment group. They too will continue to take the placebos up until the time they deliver.

Both groups: All women will be followed up on a weekly basis to assess compliance. A detailed diet history will be collected from the women at the time of enrollment, midway through the 3rd trimester and at the time of delivery. Furthermore, all women will have a detailed social history collected at the time of enrollment. Upon delivery, cord blood will be collected and sent for ellagic acid, a polyphenic component. All placental material will be sent for formal pathological exam.

If clinically stable, the infants will receive MRI evaluations to evaluate for possible brain injury.

All infants will have a formal Dubowitz neurologic exam and an attention evaluation using the Hammersmith Neonatal Neurological Examination Optimality score at term equivalent (38-41 weeks post menstrual age). Furthermore, formal neurodevelopmental follow up will take place at 18-24 months of age.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Phase I:

Inclusion Criteria:

  • Healthy expecting mothers two weeks from their expected due dates
  • No evidence of IUGR
  • No evidence of fetal problems

Phase II:

Inclusion Criteria:

  • Expecting mother with a fetal diagnosis of intrauterine growth restriction (IUGR) defined by either:

    1. Estimated fetal weight ≤ 5th percentile for gestational age and gender +/- Umbilical artery Doppler abnormalities
    2. Estimated fetal weight <10th percentile with significant abnormalities of umbilical arterial waveforms including absent and reverse end-diastolic flow
  • ≥ 2 weeks from expected due date

Exclusion Criteria:

  • Multiple congenital abnormalities
  • Known fetal chromosomal disorder
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00788866

Contacts
Contact: Russell K Lawrence, MD 314-286-1548 lawrence_r@kids.wustl.edu
Contact: Amit Mathur, MD 314-454-4031 mathur_a@kids.wustl.edu

Locations
United States, Missouri
St Louis Children's Hospital Recruiting
St Louis, Missouri, United States, 63110
Contact: Terry DeVault    314-454-4520      
Sponsors and Collaborators
Washington University School of Medicine
University of California, Los Angeles
Investigators
Principal Investigator: Russell Lawrence, MD Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Russell Lawrence, MD, Pediatrics, Division of Newborn Medicine, Washington University in St Louis
ClinicalTrials.gov Identifier: NCT00788866     History of Changes
Other Study ID Numbers: Pomegranate-1
Study First Received: November 10, 2008
Last Updated: August 3, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Neuroprotection
Antioxidants
Neonatal brain injury
Pomegranate juice

Additional relevant MeSH terms:
Fetal Growth Retardation
Brain Injuries
Wounds and Injuries
Fetal Diseases
Pregnancy Complications
Growth Disorders
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on April 20, 2014