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CompletedNCT00405704RIVURUpdated Apr 21, 2020Results posted

Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR)

A Phase 3 interventional study of Trimethoprim-Sulfamethoxazole and Placebo in Vesicoureteral Reflux and Urinary Tract Infections, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Completed at 19 sites in United States. Open to participants aged 2 Months to 71 Months. Per ClinicalTrials.gov, last updated 2020-04-21.

Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
607
Allocation
Randomized
Ages
2 Months to 71 Months
Sex
All
01

Study summary

In this 2-year, multisite, randomized, placebo-controlled trial involving 607 children with vesicoureteral reflux that was diagnosed after a first or second febrile or symptomatic urinary tract infecton, we evaluated the efficacy of Trimethoprim-Sulfamethoxazole (TMP-SMZ) prophylaxis in preventing recurrences (primary outcome). Secondary outcomes were renal scarring, treatment failure (a composite of recurrences and scarring), and antimicrobial resistance.

Read the detailed description

This multicenter, randomized, double-blind, placebo-controlled trial was designed to determine whether daily antimicrobial prophylaxis is superior to placebo in preventing recurrence of urinary tract infection (UTI) in children with vesicoureteral reflux (VUR). Eligibility criteria are described elsewhere. Patients were randomly assigned to treatment for 2 years with daily antimicrobial prophylaxis (trimethoprim-sulfamethoxazole) or placebo. The study was designed to recruit 600 children (approximately 300 in each treatment group). The protocol encouraged prompt evaluation of children with UTI symptoms and early therapy of culture-proven UTIs. It was expected that approximately 10% of children will have to discontinue study medication due to allergic reactions. Assuming a 20% placebo event rate and 10% non-compliance rate, the study has 83% power to detect an absolute 10% event rate in the antimicrobial prophylaxis group. If the placebo event rate is instead 25%, power is 97% to detect an absolute 10% event rate in the treated group, even if non-compliance is as high as 15%. The primary analysis is intention-to-treat with missing outcome data analyzed as UTI.

In addition to collecting follow-up data on urinary tract infections, renal scarring and antimicrobial resistance, quality of life, compliance, safety parameters, utilization of health resources, and change in VUR were assessed periodically throughout the study.

02

Conditions studied

  • Vesicoureteral Reflux
  • Urinary Tract Infections

Keywords

  • Vesicoureteral Reflux
  • Urinary Tract Infections
  • Renal Scarring
  • Antibiotic Resistance
  • Controlled Clinical Trial
  • Trimethoprim-Sulfamethoxazole
  • Children
03

In context

Urinary Tract Infections

753 studies on the registry are indexed under Urinary Tract Infections; 128 are open to participants now.

This study's enrollment of 607 is above the median of 130 across 524 interventional studies indexed under Urinary Tract Infections.

Browse Urinary Tract Infections studies →

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is the lead sponsor of 529 studies on the registry; 54 are open to participants now.

Of its 79 completed or terminated interventional studies of FDA-regulated products, 50 (63%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Months to 71 Months
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age at randomization: at least 2 months, but less than 6 years of age. Note that children as young as 1 month were screened for the study.
  • Diagnosed first or second febrile or symptomatic UTI within 112 days prior to randomization
  • Presence of Grade I- IV VUR based on radiographic voiding cystourethrogram (VCUG) performed within 112 days of diagnosis of index UTI.
  • Appropriately treated index febrile or symptomatic UTI

Exclusion criteria

Exclusion Criteria:

  • Index UTI diagnosis more than 112 days prior to randomization
  • History of more than two UTIs prior to randomization
  • For patients less than 6 months of age at randomization, gestational age less than 34 weeks
  • Co-morbid urologic anomalies
  • Hydronephrosis, SFU Grade 4
  • Ureterocele
  • Urethral valve
  • Solitary kidney
  • Profoundly decreased renal size unilaterally on ultrasound (based on 2 standard deviations below the mean for age and length) performed within 112 days after diagnosis of index UTI
  • Multicystic dysplastic kidney
  • Neurogenic bladder
  • Pelvic kidney or fused kidney
  • Known sulfa allergy, inadequate renal or hepatic function, Glucose-6-phosphate dehydrogenase deficiency or other conditions that are contraindications for use of TMP-SMZ
  • History of other renal injury/disease
  • Unable to complete the study protocol
  • Congenital or acquired immunodeficiency
  • Underlying anomalies or chronic diseases that could potentially interfere with response to therapy such as chronic gastrointestinal conditions (i.e., malabsorption, inflammatory bowel disease), liver or kidney failure, or malignancy.
  • Complex cardiac disease as defined in the Manual of Procedures.
  • Any known syndromes associated with VUR or bladder dysfunction
  • Index UTI not successfully treated
  • Unlikely to complete follow-up
  • Family history of anaphylactic reaction to sulfa medications
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
607 participants (actual)

Study arms

  • Active comparator
    Trimethoprim-Sulfamethoxazole

    Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.

    Drug: Trimethoprim-Sulfamethoxazole

  • Placebo comparator
    Placebo

    Cherry-flavored liquid suspension matched to active comparator.

    Drug: Placebo

Interventions

  • DrugTrimethoprim-Sulfamethoxazole

    Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.

    Also known as: Sulfatrim, Bactrim

  • DrugPlacebo

    Cherry flavored liquid suspension matched to active comparator.

06

What researchers measure

Primary outcomes

  1. Recurrent Febrile or Symptomatic Urinary Tract Infection During 2-year Follow-up

    Time frame: 2 years

Secondary outcomes

  1. Outcome Renal Scarring

    Renal scarring was defined as a decreased uptake of tracer that was associated with loss of contours or the presence of cortical thinning. Outcome dimercaptosuccinic acid (DMSA) scan was performed at 2 years after enrollment or 3-4 months after the child had met treatment failure criteria.

    Time frame: 2 years

  2. Severe Renal Scarring on Outcome Scan

    Severe renal scarring was defined as scarring in more than 4 of 12 segments in at least one kidney or global atrophy characterized by diffusely scarred and shrunken kidney. Outcome DMSA scan performed at 2 years after enrollment or 3-4 months after the child had met treatment failure criteria.

    Time frame: 2 years

  3. New Renal Scarring on Outcome Scan

    New renal scarring was defined as scarring on the outcome renal scan with technetium -99m-labeled dimercaptosuccinic acid that was not present at baseline. Outcome DMSA scan performed at 2 years after enrollment or 3-4 months after the child had met treatment failure criteria.

    Time frame: 2 years

  4. Treatment Failure Composite

    Treatment failure was defined as the occurrence of two febrile urinary tract infections (UTIs), one febrile UTI and three symptomatic UTIs, four symptomatic UTIs, or new or worsening renal scarring on an interim scan (e.g,, the 12-month visit); renal scans from the 2-year visit are NOT considered in the treatment failure criteria.

    Time frame: 2 years

  5. Presence of E.Coli Resistant to Trimethoprim-Sulfamethoxazole (TMP-SMZ) (Based on Rectal Swab)

    Time frame: 2 years

  6. Recurrent Febrile or Symptomatic UTI With Resistant E. Coli

    Time frame: 2 years

  7. Recurrent Febrile or Symptomatic UTI With Any Resistant Pathogen

    Time frame: 2 years

07

Results

Posted Apr 16, 2015
Limitations and caveats
Results may not apply to children with different demographic or clinical characteristics or in locales where choice of TMP-SMZ may be limited by susceptibility patterns or clinical acceptability. Some subgroup analyses had limited statistical power.

Participant flow

Participant flow — Overall Study
MilestoneTrimethoprim-SulfamethoxazolePlacebo
Started302305
Completed outcome renal scan227235
Completed assessments for new scarring220227
Outcome stool assessed203210
Recurrent uti with e. coli3057
Recurrent uti with tmp-smz panel3869
Completed261259
Not completed4146

Outcome measures

PrimaryRecurrent Febrile or Symptomatic Urinary Tract Infection During 2-year Follow-up
Time frame:
2 years
Reported as:
Number · participants
Recurrent Febrile or Symptomatic Urinary Tract Infection During 2-year Follow-up
participantsTrimethoprim-SulfamethoxazolePlacebo
Recurrent Febrile or Symptomatic Urinary Tract Infection During 2-year Follow-up3972
Statistical analysis
  • Trimethoprim-Sulfamethoxazole vs Placebo · Log Rank · p = <0.001
SecondaryOutcome Renal Scarring

Renal scarring was defined as a decreased uptake of tracer that was associated with loss of contours or the presence of cortical thinning. Outcome dimercaptosuccinic acid (DMSA) scan was performed at 2 years after enrollment or 3-4 months after the child had met treatment failure criteria.

Time frame:
2 years
Reported as:
Number · participants
Outcome Renal Scarring
participantsTrimethoprim-SulfamethoxazolePlacebo
Outcome Renal Scarring2724
Statistical analysis
  • Trimethoprim-Sulfamethoxazole vs Placebo · Cochran-Mantel-Haenszel · p = 0.55
SecondarySevere Renal Scarring on Outcome Scan

Severe renal scarring was defined as scarring in more than 4 of 12 segments in at least one kidney or global atrophy characterized by diffusely scarred and shrunken kidney. Outcome DMSA scan performed at 2 years after enrollment or 3-4 months after the child had met treatment failure criteria.

Time frame:
2 years
Reported as:
Number · participants
Severe Renal Scarring on Outcome Scan
participantsTrimethoprim-SulfamethoxazolePlacebo
Severe Renal Scarring on Outcome Scan96
Statistical analysis
  • Trimethoprim-Sulfamethoxazole vs Placebo · Cochran-Mantel-Haenszel · p = 0.37
SecondaryNew Renal Scarring on Outcome Scan

New renal scarring was defined as scarring on the outcome renal scan with technetium -99m-labeled dimercaptosuccinic acid that was not present at baseline. Outcome DMSA scan performed at 2 years after enrollment or 3-4 months after the child had met treatment failure criteria.

Time frame:
2 years
Reported as:
Number · participants
New Renal Scarring on Outcome Scan
participantsTrimethoprim-SulfamethoxazolePlacebo
New Renal Scarring on Outcome Scan1819
Statistical analysis
  • Trimethoprim-Sulfamethoxazole vs Placebo · Cochran-Mantel-Haenszel · p = 0.94
SecondaryTreatment Failure Composite

Treatment failure was defined as the occurrence of two febrile urinary tract infections (UTIs), one febrile UTI and three symptomatic UTIs, four symptomatic UTIs, or new or worsening renal scarring on an interim scan (e.g,, the 12-month visit); renal scans from the 2-year visit are NOT considered in the treatment failure criteria.

Time frame:
2 years
Reported as:
Number · participants
Treatment Failure Composite
participantsTrimethoprim-SulfamethoxazolePlacebo
Treatment Failure Composite1427
Statistical analysis
  • Trimethoprim-Sulfamethoxazole vs Placebo · Log Rank · p = 0.04
SecondaryPresence of E.Coli Resistant to Trimethoprim-Sulfamethoxazole (TMP-SMZ) (Based on Rectal Swab)
Time frame:
2 years
Reported as:
Number · participants
Presence of E.Coli Resistant to Trimethoprim-Sulfamethoxazole (TMP-SMZ) (Based on Rectal Swab)
participantsTrimethoprim-SulfamethoxazolePlacebo
Presence of E.Coli Resistant to Trimethoprim-Sulfamethoxazole (TMP-SMZ) (Based on Rectal Swab)5641
Statistical analysis
  • Trimethoprim-Sulfamethoxazole vs Placebo · Cochran-Mantel-Haenszel · p = 0.065
SecondaryRecurrent Febrile or Symptomatic UTI With Resistant E. Coli
Time frame:
2 years
Reported as:
Number · participants
Recurrent Febrile or Symptomatic UTI With Resistant E. Coli
participantsTrimethoprim-SulfamethoxazolePlacebo
Recurrent Febrile or Symptomatic UTI With Resistant E. Coli1911
Statistical analysis
  • Trimethoprim-Sulfamethoxazole vs Placebo · Cochran-Mantel-Haenszel · p = <0.001
SecondaryRecurrent Febrile or Symptomatic UTI With Any Resistant Pathogen
Time frame:
2 years
Reported as:
Number · participants
Recurrent Febrile or Symptomatic UTI With Any Resistant Pathogen
participantsTrimethoprim-SulfamethoxazolePlacebo
Recurrent Febrile or Symptomatic UTI With Any Resistant Pathogen2617
Statistical analysis
  • Trimethoprim-Sulfamethoxazole vs Placebo · Cochran-Mantel-Haenszel · p = <0.001

Adverse events

Collected over 2 years. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Trimethoprim-Sulfamethoxazole—0/302 (0%)79/302 (26.2%)
Placebo—0/305 (0%)105/305 (34.4%)
Most frequent other events
Most frequent other events
EventTrimethoprim-SulfamethoxazolePlacebo
FeverGeneral disorders43/30255/305
Otitis MediaGeneral disorders13/30224/305
RashGeneral disorders23/30223/305
PharyngitisGeneral disorders19/30214/305
DiarrheaGeneral disorders11/30219/305
Viral InfectionGeneral disorders14/30216/305

Baseline characteristics

Age, Continuous
Age, Continuous(months)Trimethoprim-SulfamethoxazolePlaceboTotal
Median12 (5 to 31)12 (6 to 30)12 (6 to 31)
Sex: Female, Male
Sex: Female, Male(Participants)Trimethoprim-SulfamethoxazolePlaceboTotal
Female277281558
Male252449
Region of Enrollment
Region of Enrollment(participants)Trimethoprim-SulfamethoxazolePlaceboTotal
United States302305607
08

Study locations

19 sites
  • University of Alabama
    Birmingham, Alabama 35233, United States
  • Alfred I. duPont Hospital for Children
    Wilmington, Delaware 19803, United States
  • Children's National Medical Center
    Washington, District of Columbia 20010, United States
  • Ann & Robert Lurie Children's Hospital of Chicago
    Chicago, Illinois 60614, United States
  • Johns Hopkins School of Medicine
    Baltimore, Maryland 21287, United States
  • Children's Hospital of Boston
    Boston, Massachusetts 02115, United States
  • Children's Hospital of Michigan
    Detroit, Michigan 48201, United States
  • Children's Mercy Hospital
    Kansas City, Missouri 64108, United States
  • Women and Children's Hospital of Buffalo
    Buffalo, New York 14222, United States
  • Wake Forest University Baptist Medical Center
    Winston-Salem, North Carolina 27157, United States
  • Akron Children's Hospital
    Akron, Ohio 44308, United States
  • Cincinnati Children's Hospital
    Cincinnati, Ohio 45229, United States
  • University of Oklahoma
    Oklahoma City, Oklahoma 73104, United States
  • Oregon Health & Science University
    Portland, Oregon 97239, United States
  • Penn State Hershey Medical Center
    Hershey, Pennsylvania 17033, United States
  • Children's Hospital of Philadelphia
    Philadelphia, Pennsylvania 19104, United States
  • Children's Hospital of Pittsburgh
    Pittsburgh, Pennsylvania 15213, United States
  • Texas Children's Hospital
    Houston, Texas 77030, United States
  • University of Wisconsin Children's Hospital
    Madison, Wisconsin 53792, United States
09

References and documents

Publications

  • Ziessman HA, Majd M. Importance of methodology on (99m)technetium dimercapto-succinic acid scintigraphic image quality: imaging pilot study for RIVUR (Randomized Intervention for Children With Vesicoureteral Reflux) multicenter investigation. J Urol. 2009 Jul;182(1):272-9. doi: 10.1016/j.juro.2009.02.144. Epub 2009 May 17. PubMed 19450818 ↗
  • Mathews R, Carpenter M, Chesney R, Hoberman A, Keren R, Mattoo T, Moxey-Mims M, Nyberg L, Greenfield S. Controversies in the management of vesicoureteral reflux: the rationale for the RIVUR study. J Pediatr Urol. 2009 Oct;5(5):336-41. doi: 10.1016/j.jpurol.2009.05.010. Epub 2009 Jul 1. PubMed 19570724 ↗
  • Keren R, Carpenter MA, Hoberman A, Shaikh N, Matoo TK, Chesney RW, Matthews R, Gerson AC, Greenfield SP, Fivush B, McLurie GA, Rushton HG, Canning D, Nelson CP, Greenbaum L, Bukowski T, Primack W, Sutherland R, Hosking J, Stewart D, Elder J, Moxey-Mims M, Nyberg L. Rationale and design issues of the Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR) study. Pediatrics. 2008 Dec;122 Suppl 5(Suppl 5):S240-50. doi: 10.1542/peds.2008-1285d. PubMed 19018048 ↗
  • Greenfield SP, Chesney RW, Carpenter M, Moxey-Mims M, Nyberg L, Hoberman A, Keren R, Matthews R, Mattoo T. Vesicoureteral reflux: the RIVUR study and the way forward. J Urol. 2008 Feb;179(2):405-7. doi: 10.1016/j.juro.2007.10.100. No abstract available. PubMed 18076937 ↗
  • Chesney RW, Carpenter MA, Moxey-Mims M, Nyberg L, Greenfield SP, Hoberman A, Keren R, Matthews R, Matoo TK; members of the RIVUR Steering Committee. Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR): background commentary of RIVUR investigators. Pediatrics. 2008 Dec;122 Suppl 5(0 5):S233-9. doi: 10.1542/peds.2008-1285c. PubMed 19018047 ↗
  • Keren R. Pediatrics. RIVUR trial. Introduction. Pediatrics. 2008 Dec;122 Suppl 5:S231-2. doi: 10.1542/peds.2008-1285b. No abstract available. PubMed 19086141 ↗
  • Greenfield SP, Carpenter MA, Chesney RW, Zerin JM, Chow J. The RIVUR voiding cystourethrogram pilot study: experience with radiologic reading concordance. J Urol. 2012 Oct;188(4 Suppl):1608-12. doi: 10.1016/j.juro.2012.06.032. Epub 2012 Aug 19. PubMed 22910235 ↗
  • Hoberman A, Shaikh N, Bhatnagar S, Haralam MA, Kearney DH, Colborn DK, Kienholz ML, Wang L, Bunker CH, Keren R, Carpenter MA, Greenfield SP, Pohl HG, Mathews R, Moxey-Mims M, Chesney RW. Factors that influence parental decisions to participate in clinical research: consenters vs nonconsenters. JAMA Pediatr. 2013 Jun;167(6):561-6. doi: 10.1001/jamapediatrics.2013.1050. PubMed 23546617 ↗
  • Bhatnagar S, Hoberman A, Kearney DH, Shaikh N, Moxey-Mims MM, Chesney RW, Carpenter MA, Greenfield SP, Keren R, Mattoo TK, Mathews R, Gravens-Mueller L, Ivanova A. Development and impact of an intervention to boost recruitment in a multicenter pediatric randomized clinical trial. Clin Pediatr (Phila). 2014 Feb;53(2):151-7. doi: 10.1177/0009922813506961. Epub 2013 Oct 22. PubMed 24151147 ↗
  • Chesney RW, Patters AB. Childhood vesicoureteral reflux studies: registries and repositories sources and nosology. J Pediatr Urol. 2013 Dec;9(6 Pt A):731-7. doi: 10.1016/j.jpurol.2012.09.003. Epub 2012 Oct 5. PubMed 23044377 ↗
  • Carpenter MA, Hoberman A, Mattoo TK, Mathews R, Keren R, Chesney RW, Moxey-Mims M, Greenfield SP; RIVUR Trial Investigators. The RIVUR trial: profile and baseline clinical associations of children with vesicoureteral reflux. Pediatrics. 2013 Jul;132(1):e34-45. doi: 10.1542/peds.2012-2301. Epub 2013 Jun 10. PubMed 23753091 ↗
  • RIVUR Trial Investigators; Hoberman A, Greenfield SP, Mattoo TK, Keren R, Mathews R, Pohl HG, Kropp BP, Skoog SJ, Nelson CP, Moxey-Mims M, Chesney RW, Carpenter MA. Antimicrobial prophylaxis for children with vesicoureteral reflux. N Engl J Med. 2014 Jun 19;370(25):2367-76. doi: 10.1056/NEJMoa1401811. Epub 2014 May 4. PubMed 24795142 ↗
  • Primack W, Bukowski T, Sutherland R, Gravens-Mueller L, Carpenter M. What Urinary Colony Count Indicates a Urinary Tract Infection in Children? J Pediatr. 2017 Dec;191:259-261.e1. doi: 10.1016/j.jpeds.2017.08.012. Epub 2017 Sep 28. PubMed 28967387 ↗
  • Keren R, Shaikh N, Pohl H, Gravens-Mueller L, Ivanova A, Zaoutis L, Patel M, deBerardinis R, Parker A, Bhatnagar S, Haralam MA, Pope M, Kearney D, Sprague B, Barrera R, Viteri B, Egigueron M, Shah N, Hoberman A. Risk Factors for Recurrent Urinary Tract Infection and Renal Scarring. Pediatrics. 2015 Jul;136(1):e13-21. doi: 10.1542/peds.2015-0409. Epub 2015 Jun 8. PubMed 26055855 ↗

Individual participant data

Plan to share: Yes — Data are available at the NIDDK Central Repository: https://repository.niddk.nih.gov/studies/rivur/?query=rivur

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 21, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00405704
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators
University of North Carolina, Chapel Hill
Responsible party
Sponsor
First posted
Nov 30, 2006
Start date
May 2007
Primary completion
Jun 2013
Completion
May 2014
Results posted
Apr 16, 2015
Last update
Apr 21, 2020

Study contacts

Sahar Fathallah, MD
principal investigator · University of Alabama, Birmingham, AL
Myra A Carpenter, PhD
principal investigator · University of NC at Chapel Hill, Chapel Hill, NC
Caleb P. Nelson, MD, MPH
principal investigator · Children's Hospital of Boston, Boston, MA
Eileen Brewer, MD
principal investigator · Texas Children's Hospital, Houston, TX
Saul P Greenfield, MD
principal investigator · Women and Children's Hospital of Buffalo, Buffalo, NY
Alejandro Hoberman, MD
principal investigator · Children's Hospital of Pittsburgh, Pittsburgh, PA
Ron Keren, MD, MPH
principal investigator · Children's Hospital of Philadelphia, Philadelphia, PA
Bradley P Kropp, MD
principal investigator · University of Oklahoma, Oklahoma City, OK
Ranjiv Mathews, MD
principal investigator · Johns Hopkins University
Tej K Mattoo, MD,DCH, FRCP
principal investigator · Wayne State University School of Medicine, Detroit, MI
H. Gil Rushton, MD, FAAP
principal investigator · Children's National Research Institute
Mary Ann Queen, MD
principal investigator · Children's Mercy Hospital Kansas City
Russell W Chesney, MD
study chair · Le Bonheur Children's Medical Center, Memphis, TN
Steven J Skoog, MD FACS,FAAP
principal investigator · Oregon Health & Science University, Portland, OR
Amy Renwick, MD
principal investigator · Alfred I. duPont Hospital for Children, Wilmington, DE
Earl Y. Cheng, MD
principal investigator · Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL
Milan Nadkarni, MD
principal investigator · Wake Forest University Baptist Medical Center, Winston-Salem, NC
Caleb P Nelson, MD, MPH
principal investigator · Children's Hospital of Boston, Boston, MA
William R DeFoor, Jr, MD, MPH
principal investigator · Cincinnati Children's Hospital, Cincinnati, OH
Dan McMahon, MD
principal investigator · Akron Children's Hospital, Akron, OH
Ross Decter, MD
principal investigator · Penn State Hershey Medical Center, Hershey, PA
Sharon M Bartosh, MD
principal investigator · University of Wisconsin, Madison

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
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