Pilot Study of the Rotavirus Vaccine in Infants With Intestinal Failure
NCT ID: NCT00995813
Last Updated: 2015-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
15 participants
INTERVENTIONAL
2009-12-31
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Interventions
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Rotarix
A rotavirus vaccine (Rotarix) will be administered in two doses, 8 weeks apart, in infants between 6 and 14 weeks of age. The standard dosage is 1 mL administered orally or per gastrostomy tube.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
6 Weeks
14 Weeks
ALL
No
Sponsors
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Thrasher Research Fund
OTHER
National Center for Research Resources (NCRR)
NIH
Seattle Children's Hospital
OTHER
Responsible Party
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Patrick Javid
Principal Investigator
Principal Investigators
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Patrick J Javid, MD
Role: PRINCIPAL_INVESTIGATOR
Seattle Children's Hospital and The University of Washington
Simon Horslen, M.B., ChB
Role: PRINCIPAL_INVESTIGATOR
Seattle Children's Hospital and The University of Washington
Janet Englund, MD
Role: PRINCIPAL_INVESTIGATOR
Seattle Children's Hospital and The University of Washington
Locations
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Seattle Children's Hospital
Seattle, Washington, United States
Countries
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Other Identifiers
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RS_Rota_vaccine_if
Identifier Type: -
Identifier Source: org_study_id