Clinical Trial Summary

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Phase

Phase 3

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Funding Agency/Sponsor

Other

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Disease

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Enrollment Eligibility

Inclusion Criteria:
- Gestational age between 28 and 32 weeks
- Birthweight between 800 and 1,400 grams
- Birthweight, length, and head circumference appropriate for gestational age
- Scores on the Obstetric/Postnatal Complications scales are each below 80
- NICU stay between 15 and 60 days
- Current weight between 1,000 and 1,500 grams
- Current daily intake is between 120 and 160 calories
Exclusion Criteria:
- Genetic anomalies, congenital heart malformations, and/or central nervous system
dysfunction
- HIV infection
- History of maternal alcohol or illicit drug use
- Syphilis
- Hepatitis B
- Require surgery

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