Impact of Maternal Pomegranate Juice on Brain Injury in Infants With Intrauterine Growth Restriction (IUGR) (POM-1)
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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) |
- 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 ]
- 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 |
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:
- Estimated fetal weight ≤ 5th percentile for gestational age and gender +/- Umbilical artery Doppler abnormalities
- 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| 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 |
| United States, Missouri | |
| St Louis Children's Hospital | Recruiting |
| St Louis, Missouri, United States, 63110 | |
| Contact: Terry DeVault 314-454-4520 | |
| Principal Investigator: | Russell Lawrence, MD | Washington University in St. Louis |
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 Fetal Diseases Pregnancy Complications Growth Disorders Pathologic Processes |
Brain Diseases Central Nervous System Diseases Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on June 17, 2013