Pilot Study of the Rotavirus Vaccine in Infants With Intestinal Failure

Seattle Children's Healthcare System

Status and phase: Completed; Phase 4

Conditions: Intestinal Failure; Rotavirus Vaccines

Treatments: Biological: Rotarix

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00995813

RS_Rota_vaccine_if

Details and patient eligibility

About

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

Enrollment: 15 patients

Sex: All

Ages: 6 to 14 weeks old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)