Impact of Maternal Pomegranate Juice on Brain Injury in Infants With Intrauterine Growth Restriction (IUGR) - Full Text View

Sponsors and Collaborators:	Washington University School of Medicine University of California, Los Angeles
Information provided by:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00788866

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

MedlinePlus related topics: Antioxidants Dietary Supplements Traumatic Brain Injury

Drug Information available for: Ascorbic acid

U.S. FDA Resources

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

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:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Pomegranate juice: Experimental 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: Placebo Comparator 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
St Louis, Missouri, United States, 63110

Sponsors and Collaborators

Washington University School of Medicine

University of California, Los Angeles

Investigators

Principal Investigator:

Russell Lawrence, MD

Washington University in St Louis

More Information

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

Keywords provided by Washington University School of Medicine:

Neuroprotection
Antioxidants
Neonatal brain injury
Pomegranate juice

Study placed in the following topic categories:

Craniocerebral Trauma
Fetal Diseases
Pregnancy Complications
Growth Disorders
Wounds and Injuries
Disorders of Environmental Origin

Central Nervous System Diseases
Trauma, Nervous System
Brain Diseases
Brain Injuries
Ascorbic Acid
Fetal Growth Retardation

Additional relevant MeSH terms:

Pathologic Processes
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009