Pilot Study of the Rotavirus Vaccine in Infants With Intestinal Failure

Pilot Study of the Safety and Immunogenicity of the Rotavirus Vaccine in Infants With Intestinal Failure

The purpose of this study is to assess the safety and immune response of the rotavirus vaccine in infants who have undergone abdominal surgery.

Inclusion Criteria:

• Infants with one of the following diagnoses:

  • necrotizing enterocolitis requiring operation;
  • congenital atresia of the intestine;
  • gastroschisis;
  • midgut volvulus requiring bowel resection; or
  • long-segment intestinal aganglionosis

• Minimum gestational age of 35 weeks at time of first vaccine dose

Exclusion Criteria:

• immunocompromise secondary to HIV infection or immunodeficiency state
• active use of corticosteroid or other immunosuppressive agents
• active infection as defined by fever > 38°C within 24 hours, positive blood culture within 7 days, or positive urine culture within 3 days of enrollment
• severe malnutrition as defined by serum albumin < 2.0 mg/dL or serum prealbumin < 6 mg/dL.