Pilot Study of the Rotavirus Vaccine in Infants With Intestinal Failure
Phase 4
Completed
- Conditions
- Intestinal FailureRotavirus Vaccines
- Registration Number
- NCT00995813
- Lead Sponsor
- Seattle Children's Hospital
- Brief Summary
The purpose of this study is to assess the safety and immune response of the rotavirus vaccine in infants who have undergone abdominal surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method The safety of the rotavirus vaccine in infants with intestinal failure is the primary outcome variable. 1-12 weeks following vaccine administration
- Secondary Outcome Measures
Name Time Method The secondary outcome measure is the preliminary measurement of the immunogenicity of the rotavirus vaccine in infants with intestinal failure. 1-12 weeks following vaccine administration
Trial Locations
- Locations (1)
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States