Status:
COMPLETED
Pilot Study of the Rotavirus Vaccine in Infants With Intestinal Failure
Lead Sponsor:
Seattle Children's Hospital
Collaborating Sponsors:
Thrasher Research Fund
National Center for Research Resources (NCRR)
Conditions:
Intestinal Failure
Rotavirus Vaccines
Eligibility:
All Genders
6-14 years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00995813
Start Date
December 1 2009
End Date
July 1 2013
Last Update
November 18 2015
Active Locations (1)
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1
Seattle Children's Hospital
Seattle, Washington, United States, 98105