NCT00004414

Who might be able to join this trial:

• Newborns weighing less than 1,000 grams (about 2.2 pounds) at birth AND born at 28 weeks of pregnancy or earlier, who need more than half of their nutrition given through a vein within the first 7 days of life
• Newborns (within 7 days of diagnosis) who have a serious intestinal condition called necrotizing enterocolitis (a disease where parts of the bowel become damaged)
• Newborns (within 7 days of diagnosis) who were born with gastroschisis (a condition where the intestines are outside the body through an opening in the belly)
• Newborns (within 7 days of diagnosis) who have a serious blockage or gap in the small intestine (called severe jejunal-ileal atresia)

Who may not be able to join:

• Babies who have had or are having heart surgery (opening the chest) or major bowel/abdominal surgery during the newborn period
• Babies who have been given or are currently taking a medication called ursodeoxycholic acid
• Babies currently on a life support machine that works outside the body to support the heart and lungs (called extracorporeal life support)
• Babies with a bilirubin (a liver-related chemical) level in the blood above 1.0 mg/dL
• Babies who already have a liver disease or liver failure (confirm with trial site)
• Babies whose kidneys are getting progressively worse, shown by rising creatinine levels in the blood
• Babies who are medically unstable (confirm with trial site)
• Babies with a known, active communicable infection, including hepatitis or HIV
• Babies with certain inherited conditions that affect how the body processes food and can harm the liver, including hereditary fructose intolerance, galactosemia (a sugar processing disorder), or neonatal tyrosinemia (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.