Study of MEDI-524 (Motavizumab) for the Prophylaxis of Serious Respiratory Syncytial Virus (RSV) Disease in High-Risk Children

NCT ID: NCT00129766

Last Updated: 2013-08-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

6635 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2006-05-31

Brief Summary

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The primary objective of this study was to compare the safety and efficacy of motavizumab to palivizumab when administered monthly by intramuscular (IM) injection for the reduction of the incidence of RSV hospitalization among children at high risk for serious RSV disease. A secondary objective was to compare the incidence of medically-attended lower respiratory infections (LRIs) between treatment groups.

Detailed Description

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A randomized, double-blind, palivizumab-controlled, multi-center, multi-national trial conducted during 2 Northern Hemisphere RSV seasons with an intervening season in the Southern Hemisphere. Each child only participated during a single RSV season. Approximately 6,600 children at risk for serious RSV disease were to be randomized in a 1:1 ratio to receive either 15 mg/kg of palivizumab or motavizumab by IM injection every 30 days for a total of 5 doses.

Conditions

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Respiratory Syncytial Virus Infections

Keywords

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Respiratory Syncytial Virus (RSV) motavizumab palivizumab Synagis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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palivizumab

15 mg/kg administered intramuscularly for 5 monthly doses

Group Type ACTIVE_COMPARATOR

palivizumab

Intervention Type BIOLOGICAL

Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses

motavizumab (MEDI-524)

15 mg/kg of motavizumab was administered intramuscularly for 5 monthly doses

Group Type EXPERIMENTAL

motavizumab (MEDI-524)

Intervention Type BIOLOGICAL

Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses

Interventions

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motavizumab (MEDI-524)

Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses

Intervention Type BIOLOGICAL

palivizumab

Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses

Intervention Type BIOLOGICAL

Other Intervention Names

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MEDI-524 Synagis

Eligibility Criteria

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Inclusion Criteria

* 24 months of age or younger at randomization (child must be randomized on or before his/her 24-month birthday) with a diagnosis of chronic lung disease (CLD) of prematurity requiring medical intervention/management (i.e., supplemental oxygen, bronchodilators, or diuretics) within 6 months before randomization

OR:

* 35 weeks gestational age or less at birth and 6 months of age or younger at randomization (children were to be randomized on or before his/her 6-month birthday)

Exclusion Criteria

* Hospitalization at the time of randomization (unless discharge was anticipated within 10 days)
* Mechanical ventilation or other mechanical support (including continuous positive airways pressure \[CPAP\])
* Life expectancy \< 6 months
* Active RSV infection (a child with signs/symptoms of respiratory infection must have had negative RSV testing)
* Known renal impairment
* Known hepatic dysfunction
* Chronic seizure or evolving or unstable neurologic disorder
* Congenital heart disease \[CHD\] (children with uncomplicated CHD \[e.g., patent ductus arterious (PDA), small septal defect\] and children with complicated CHD that were currently anatomically and hemodynamically normal could be enrolled)
* Known immunodeficiency
* Mother with HIV infection (unless the child has been proven to be not infected)
* Known allergy to Ig products
* Receipt of palivizumab, RSV-IGIV, or other RSV-specific monoclonal antibody, or any other polyclonal antibody (for example, hepatitis B IG, IVIG, VZIG) within 3 months prior to randomization
* Anticipated use of palivizumab or IVIG during the study (blood transfusions permitted)
* Previous receipt of RSV vaccines
* Participation in other investigational drug product studies
Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MedImmune LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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M Pamela Griffin, MD

Role: STUDY_DIRECTOR

MedImmune LLC

Locations

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University Of Alabama At Birmingham

Birmingham, Alabama, United States

Site Status

Alabama Neonatal Medicine OC

Pike Road, Alabama, United States

Site Status

Maricopa Medical Center

Phoenix, Arizona, United States

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Central Arkansas Pediatric Clinic, PA

Benton, Arkansas, United States

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The Children's Clinic Of Jonesboro, P.A.

Jonesboro, Arkansas, United States

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Arkansas Children's Hospital Research Institute

Little Rock, Arkansas, United States

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Arkansas Pediatric Clinic

Little Rock, Arkansas, United States

Site Status

Little Rock Children's Clinic, PA

Little Rock, Arkansas, United States

Site Status

Miller Children's Hospital

Long Beach, California, United States

Site Status

Kaiser Permanente Los Angeles

Los Angeles, California, United States

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Children's Hospital of Oakland

Oakland, California, United States

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Kaiser Permanente Health Care Plan

Oakland, California, United States

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Children's Hospital of Orange County

Orange, California, United States

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University of California

San Diego, California, United States

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Children's Hospital San Diego

San Diego, California, United States

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California Pacific Medical Center

San Francisco, California, United States

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Santa Clara Valley Medical Center

San Jose, California, United States

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Children's Hospital

Denver, Colorado, United States

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Connecticut Children's Medical Center

Hartford, Connecticut, United States

Site Status

Pediatric Pulmonology, LLC

Stamford, Connecticut, United States

Site Status

A. I. Dupont Hospital For Children

Wilmington, Delaware, United States

Site Status

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Site Status

Children's National Medical Center

Washington D.C., District of Columbia, United States

Site Status

Shands Hospital At The University Of Florida

Gainesville, Florida, United States

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The Nemours Children's Clinic

Jacksonville, Florida, United States

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University Of Miami Medical Center

Miami, Florida, United States

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Nemours Children's Clinic Biomedical Research

Orlando, Florida, United States

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Univ. S. Florida Pediatrics Ambulatory Care Center

Tampa, Florida, United States

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Emory University School Of Medicine

Atlanta, Georgia, United States

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Georgia Pediatric Pulmonology Associates

Atlanta, Georgia, United States

Site Status

The Medical College Of Georgia

Augusta, Georgia, United States

Site Status

Kapiolani Medical Center for Woman and Children

Honolulu, Hawaii, United States

Site Status

University of Illinois at Chicago

Chicago, Illinois, United States

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Children's Memorial Hospital

Chicago, Illinois, United States

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Advocate Hope Children's Hospital

Cook, Illinois, United States

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Lutheran General Children's Hospital

Park Ridge, Illinois, United States

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James Whitcomb Riley Hospital for Children

Indianapolis, Indiana, United States

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Memorial Hospital of South Bend

South Bend, Indiana, United States

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University of Louisville

Louisville, Kentucky, United States

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Louisiana State University MidCity Clinic

Baton Rouge, Louisiana, United States

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Tulane Hospital for Children

New Orleans, Louisiana, United States

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University Of Maryland School of Medicine

Baltimore, Maryland, United States

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Tufts-New England Medical Center

Boston, Massachusetts, United States

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Boston Medical Center

Boston, Massachusetts, United States

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Baystate Medical Center

Springfield, Massachusetts, United States

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University of Michigan Mott Children's Hospital

Ann Arbor, Michigan, United States

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Children's Hospital Of Michigan

Detroit, Michigan, United States

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St. John Hospital & Medical Center

Detroit, Michigan, United States

Site Status

DeVos Children's Hospital

Grand Rapids, Michigan, United States

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St. Mary's Duluth Clinic

Duluth, Minnesota, United States

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Children's Healthcare D.B.A. Hospitals & Clinics

Saint Paul, Minnesota, United States

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Children's Mercy Hospital

Kansas City, Missouri, United States

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Research Medical Center

Kansas City, Missouri, United States

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University of Nebraska Medical Center Pediatric

Omaha, Nebraska, United States

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Children's Lung Specialist, Ltd

Las Vegas, Nevada, United States

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Dartmouth Medical School

Lebanon, New Hampshire, United States

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Saint Barnabas Medical Center

Livingston, New Jersey, United States

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New Jersey Medical School

Newark, New Jersey, United States

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Albany Medical Center

Albany, New York, United States

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The Brooklyn Hospital Center

Brooklyn, New York, United States

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Women & Children's Hospital

Buffalo, New York, United States

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Winthrop University Hospital

Mineola, New York, United States

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Schneider Children's Hospital

New Hyde Park, New York, United States

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The Children's Medical Group

Poughkeepsie, New York, United States

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University Of Rochester Medical Center

Rochester, New York, United States

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University Hospital State University of New York at Stony Brook Department of Pediatrics

Stony Brook, New York, United States

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Crouse Hospital NICU

Syracuse, New York, United States

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SUNY Upstate Medical University

Syracuse, New York, United States

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Bronx-Lebanon Hospital Center

The Bronx, New York, United States

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Jacobi Medical Center

The Bronx, New York, United States

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Montefiore Medical Center

The Bronx, New York, United States

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University of North Carolina-School of Medicine

Chapel Hill, North Carolina, United States

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Carolinas Medical Center

Charlotte, North Carolina, United States

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Duke University Medical Center

Durham, North Carolina, United States

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East Carolina University School of Medicine

Greenville, North Carolina, United States

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Raleigh Pediatric Associates

Raleigh, North Carolina, United States

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Wake Forest University School of Medicine

Winston-Salem, North Carolina, United States

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Children's Hospital Medical Center Of Akron

Akron, Ohio, United States

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Beehly Medical Park Women's and Children's Pav.

Boardman, Ohio, United States

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University of Cincinnati Col. of Med.

Cincinnati, Ohio, United States

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Metro Health Medical Center

Cleveland, Ohio, United States

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Pediatric Clinical Trials International, Inc.

Columbus, Ohio, United States

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Children's Medical Center

Dayton, Ohio, United States

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Tod Children's Hospital

Mahaning, Ohio, United States

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Toledo Children's Hospital

Toledo, Ohio, United States

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St. Vincent Medical Center

Toledo, Ohio, United States

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Children's Hospital Of Oklahoma

Oklahoma City, Oklahoma, United States

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Saint Francis Hospital EOPC

Tulsa, Oklahoma, United States

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Oregon Health Sciences University

Portland, Oregon, United States

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Lehigh Valley Hospital

Allentown, Pennsylvania, United States

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St. Luke's Hospital

Bethlehem, Pennsylvania, United States

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Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, United States

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Geisinger Medical Center- JW Children's Hospital

Danville, Pennsylvania, United States

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The Children's Hospital Of Philadelphia

Philadelphia, Pennsylvania, United States

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Jefferson-duPont Children's Health Program

Philadelphia, Pennsylvania, United States

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Pennsylvania Hospital

Philadelphia, Pennsylvania, United States

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Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

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Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

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Rhode Island Hospital

Providence, Rhode Island, United States

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MUSC

Charleston, South Carolina, United States

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Sioux Valley Hospital University of South Dakota Medical Center

Sioux Falls, South Dakota, United States

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Lebonheur Children's Medical Center

Memphis, Tennessee, United States

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

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Driscoll Children's Hospital

Corpus Christi, Texas, United States

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Baylor University Medical Center

Dallas, Texas, United States

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Univ. Of Texas Southwestern Medical Center

Dallas, Texas, United States

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Texas Children's Hospital

Houston, Texas, United States

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University Of Texas Houston Medical School

Houston, Texas, United States

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Texas Tech Health Sciences Center

Lubbock, Texas, United States

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University Of Texas Health Science Center

San Antonio, Texas, United States

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Scott & White Memorial Hospital

Temple, Texas, United States

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Primary Children's Medical Center

Salt Lake City, Utah, United States

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University of Virginia Hospital

Charlottesville, Virginia, United States

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VCU Medical Center

Richmond, Virginia, United States

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University Physicians

Huntington, West Virginia, United States

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West Virginia University

Morgantown, West Virginia, United States

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Marshfield Clinic

Marshfield, Wisconsin, United States

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St. Joseph's Hospital

Milwaukee, Wisconsin, United States

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Waukesha Memorial Hospital, Inc

Waukesha, Wisconsin, United States

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Children's Corporate Center

Wauwatosa, Wisconsin, United States

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Hospital Peiade Interzonal General de Augodos

Buenos Aires, , Argentina

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Hospital General De Ninos Pedro De Elizalde

Buenos Aires, , Argentina

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Sanatorio Trinidad

Capital Federal, , Argentina

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Hospital Materno Neonatal

Córdoba, , Argentina

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The Canberra Hospital

Garran, Australian Capital Territory, Australia

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John Hunter Children's Hospital

New Lambton, New South Wales, Australia

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Westmead Hospital

Westmead, New South Wales, Australia

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Royal Children's Hospital (Brisbane)

Herston, Queensland, Australia

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Peninsula Clinical Research Centre

Kippa-Ring, Queensland, Australia

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Mater Mothers Hospital Raymond Terrace

South Brisbane, Queensland, Australia

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Royal Hobart Hospital

Hobart, Tasmania, Australia

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Royal Children's Hospital (Melbourne)

Parkville, Victoria, Australia

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Princess Margaret Children's Hospital

Subiaco, Western Australia, Australia

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Women's and Children's Hospital

North Adelaide, , Australia

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Universitatsklinik fur Kinder und Jugenheilkunde, Graz

Graz, , Austria

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LandesKrankenHaus Tulln, Kinderabteilung

Tulln, , Austria

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Allgemeines KrankenHaus Universitatsklinkiken Wein

Vienna, , Austria

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SMZ-Ost Donauspital Wien

Vienna, , Austria

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Hospital e Maternidade Celso Pierro-Puccamp

Campinas, , Brazil

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Mernidade Nossa Senhora De Fatima

Curitiba, , Brazil

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Hospital De Clinicas Da UFPR

Curitiba, , Brazil

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Hospital Sao Lucas da PUC-RS de Riberiao Perto da Universidade de Sao Paulo

Porto Alegre, , Brazil

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Hospital Das Clinicas Da Faculdade De Medicina

Ribeirão Preto, , Brazil

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Santa Casa de Misericordia de Sao Paulo

São Paulo, , Brazil

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Hospital e Maternidade Santa Marina

São Paulo, , Brazil

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Hospital Universitario de Universidade de Sao Paulo

São Paulo, , Brazil

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Multifunctional Hospital for Active Treatment "Pleven"

Pleven, , Bulgaria

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University Multifunctional Hospital for Active Treatment "St. George" Neonatology Clinic

Plovdiv, , Bulgaria

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University Multifunctional Hospital for Active Treatment "St. George" Clinic of Pediatrics

Plovdiv, , Bulgaria

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Multifunctional Hospital for Active Treatment - Plovdiv

Plovdiv, , Bulgaria

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Regional Hospital of Pulmonary Diseases

Rousse, , Bulgaria

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Specialized Hospital for Active Treatment of Cardio-vascular Diseases

Sofia, , Bulgaria

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Specialized Hospital for Active Treatment of Obstetrics and Gynaecology"-"Maichin Dom"

Sofia, , Bulgaria

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Specialized Hospital for Active Treatment of Pediatric Diseases

Sofia, , Bulgaria

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Multifunctional Hospital for Active Treatment "St. Marina"

Varna, , Bulgaria

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Alberta Children's Hospital

Calgary, , Canada

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Queen Elizabeth Hospital

Charlottetown, , Canada

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University Of Alberta/Stollery Children's Hospital

Edmonton, , Canada

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Dalhousie University IWK Health Centre

Halifax, , Canada

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Mcmaster Children's Hospital

Hamilton, , Canada

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McGill University Health Centre Monteal Children's Hospital

Montreal, , Canada

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Sainte Justine Hospital

Montreal, , Canada

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Children's Hospital of Eastern Ontario

Ottawa, , Canada

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Centre Hospitalier de L'Universite Laval

Québec, , Canada

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Royal University Hospital

Saskatoon, , Canada

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Children's And Women's Hospital of BC

Vancouver, , Canada

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Victoria General Hospital

Victoria, , Canada

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Windsor Regional Hospital

Windsor, , Canada

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Manitoba Institute Of Child Health University of Manitoba

Winnipeg, , Canada

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Hospital San Jose

Independencia, , Chile

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Hospital Clinico de la Universidad de Chile

Independencia, , Chile

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Hospital Dr. Sotero Del Rio

Puente Alto, , Chile

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Hospital Dr. Feliz Buines Cerda

Quinta Normal, , Chile

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Hospital Clinico San Borja Arriaran

Santiago, , Chile

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Hospital Padre Hurtado

Santiago, , Chile

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Nemocnice CB

České Budějovice, , Czechia

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FN Hradec Kralove Detska klinika

Hradec Králové, , Czechia

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Nemocnice s poliklinikou v Moste

Most, , Czechia

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Fakultni nemocnice

Olomouc, , Czechia

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FNsP Ostrava

Ostrava, , Czechia

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FN Plzen

Plzen-Bory, , Czechia

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FN Plzen

Plzen-Lochotin, , Czechia

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Vfn 1.Lf Uk

Prague, , Czechia

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Fakultni Thomayerova nemocnice S poliklinkou

Prague, , Czechia

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Ustav pro peci o matku a dite

Prague, , Czechia

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FN Motol Novorozenecke oddeleni

Prague, , Czechia

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Batova krajska nemocnice Zlin

Zlín, , Czechia

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Paediatrisk Afdeling Herning Centralsygehus

Herning, , Denmark

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Hillerod Sygehus Helsevej 2

Hillerød, , Denmark

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Hvidovre Hospital

Hvidovre, , Denmark

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Sygehus Viborg

Viborg, , Denmark

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Service de Medecine Neonatale et de reanimation pediatrique

Amiens, , France

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CHU Angers

Angers, , France

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CHU de Besancon-Hopital Saint-Jacques

Besançon, , France

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CHU Bordeaux/Hopital des enfants/Unite de Neonatologie B

Bordeaux, , France

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CH Chambery

Chambéry, , France

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CHU Dijon

Dijon, , France

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Hopital Jeanne de Flandre

Lille, , France

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CHU Nord

Marseille, , France

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CHU Montpellier/Hoptial Arnaud de Villeneuve

Montpellier, , France

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CHU de Nantes/Hospital Mere-Enfant

Nantes, , France

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CHI Poissy/St Germain en Laye

Poissy, , France

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CHU Rennes/Hopital Sud

Rennes, , France

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CHU Rouen

Rouen, , France

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CH Pierre Haute

Strasbourg, , France

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CHU Toulouse-Hopital des Enfants

Toulouse, , France

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Centre Pediatrique Gatien de Clocheville

Tours, , France

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Ruhr-Uni St. Josef Hospital

Bochum, , Germany

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Klinikum Duisburg, Wedau Kliniken

Duisburg, , Germany

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Uni-Kinderklinik

Düsseldorf, , Germany

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Klinik fur Kinder und Jugendliche

Erlangen, , Germany

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Zentrum Klinische Studien/Universtatsklinikum Freiburg

Freiburg im Breisgau, , Germany

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Universtatsklinikum Gottingen

Göttingen, , Germany

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Wittenberg/Zentrum: fur Kinderheilkunde, Universitatsklinik und Poliklinik fur Kinder and Jugendmedizin

Halle, , Germany

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Stiftung Hannoversche

Hanover, , Germany

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Im Neuenheimer Feld 153

Heidelberg, , Germany

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Klinik und Poliklinik und Jugendiche der Universitat Leipzig

Leipzig, , Germany

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Universitatskinderlinik/Zentrum Fur klinische Studien

Mainz, , Germany

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Kinderklinik und Kinderpoliklinik

München, , Germany

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Stadtisches Krankenhaus Muchen-Harlaching

München, , Germany

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Evangelischisches Krankenhaus

Oberhausen, , Germany

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Klinikum Oldenberg

Oldenberg, , Germany

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Klinikum Rosenheim

Rosenheim, , Germany

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Asklepios Kinderklinik Sankt Augustin GmbH

Sankt Augustin, , Germany

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"P&A Kyriakou" Children's hospital

Athens, , Greece

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Aghia Sofia Children hospital

Athens, , Greece

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Aristotele University of Thessaloniki, General "AXEPA" Hospital

Thessaloniki, , Greece

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Hippokration Hospital, University of Thessaloniki

Thessaloniki, , Greece

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General hospital "Papageorgiou"

Thessaloniki, , Greece

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Semmelweis Univ.

Budapest, , Hungary

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Semmelweis University

Budapest, , Hungary

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Schopf-Merei Agost Hospital

Budapest, , Hungary

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Semmelweis Univ.

Budapest, , Hungary

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DEOEC Neonatology Division

Debrecen, , Hungary

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DEOEC, Dept. of Pediatry

Debrecen, , Hungary

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Petz Aladar Teaching Hospital

Győr, , Hungary

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Borsod-Abaúj-Zemplén Megyei Önkormányzat Kórháza

Miskolc, , Hungary

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Josa Andras Hospital

Nyíregyháza, , Hungary

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University of Pecs

Pécs, , Hungary

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Univ. of Pecs

Pécs, , Hungary

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Csolnoky Ferenc Hospital

Veszprém, , Hungary

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Children's hospital, Landspitali University Hospital

Reykjavik, , Iceland

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HaEmek Medical Center

Afula, , Israel

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Barzilai Medical Center

Ashkelon, , Israel

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Soroka Medical Center

Beersheba, , Israel

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Bnei Zion Medical Center

Haifa, , Israel

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Rambam Medical Center

Haifa, , Israel

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Carmel Medical Center

Haifa, , Israel

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Wolfson Medical Center

Holon, , Israel

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Shaare Zedek Medical Center

Jerusalem, , Israel

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Hadassah Ein-Kerem Medical Center

Jerusalem, , Israel

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Sapir Medical Center

Kfar Saba, , Israel

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Laniado Medical Center

Netanya, , Israel

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Schneider Medical Center

Petah Tikva, , Israel

Site Status

Kaplan Medical Center

Rehovot, , Israel

Site Status

Sourasky Medical Center (Ichilov)

Tel Aviv, , Israel

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Chaim Sheba Medical Center

Tel Litwinsky, , Israel

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Poria Medical Center

Tiberias, , Israel

Site Status

Presio Ospedaliero di Alta Specializzazione "G. Salesi" - Azienda Ospedaliera Universitaria - Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"

Ancona, , Italy

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Ospedali Riuniti di Bergamo - Azienda Ospedaliera/Unità Operativa di Patologia Neonatale

Bergamo, , Italy

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Azienda Ospedaliera di Bologna - Policlinico S. Orsola - Malpighi

Bologna, , Italy

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Ospedale Generale di Bolzano

Bolzano, , Italy

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Spedali Civili di Brescia

Brescia, , Italy

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Azienda Ospedaliera S. Croce e Carle

Cuneo, , Italy

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Azienda Ospedaliera Universitaria

Foggia, , Italy

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Azienda USL di Imola - Ospedale di Imola

Imola, , Italy

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Ospedale Alessandro Manzoni Lecco - Presidio dell'Azienda Ospedaliera "Ospedale di Lecco"

Lecco, , Italy

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Azienda Ospedaliera Universitaria Policlinico Gaetano Martino

Messina, , Italy

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Azienda Ospedaliera San Gerardo

Monza, , Italy

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Azienda Ospedaliera di Parma

Parma, , Italy

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Azienda Ospedaliera Universitaria Pisana - Ospedale S. Chiara

Pisa, , Italy

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Azienda Sanitaria Ospedaliera O.I.R.M.-S. Anna

Torino, , Italy

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Azienda Ospedaliera S. Maria della Misericordoa Struttura Operativa Complessa di Patologia Neonatale e terapia Intesiva Neonatale

Udine, , Italy

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Middlemore Hospital

Auckland, , New Zealand

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Dunedin Hospital

Dunedin, , New Zealand

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Waikato Hospital

Hamilton, , New Zealand

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Palmerston North Hospital

Palmerston North, , New Zealand

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Klinika Neonatologii AM w Białymstoku

Bialystok, , Poland

Site Status

Samodzielny Publiczny Zakład Opieki Zdrowotnej Wojewódzki Szpital im. dr Jana Biziela w Bydgoszczy, Oddział Noworodków, Wcześniaków I Intensywnej Terapii Noworodka

Bydgoszcz, , Poland

Site Status

Oddział Pediatrii i Kardiologii z pododdziałem Patologii Noworodka

Bydgoszcz, , Poland

Site Status

Wojewódzki Szpital Specjalistyczny, Oddział Dziecięcy

Częstochowa, , Poland

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Samodzielny Publiczny Szpital Kliniczny nr 1, Klinika Neonatologii

Gdansk, , Poland

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Szpital Morski im. PCK, Oddział Dziecięcy

Gdynia, , Poland

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Oddzial Kliniczny Kliniki Neonatologii Szpitala Uniwersyteckiego w Krakowie

Krakow, , Poland

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Szpital Kliniczny nr 4 im.M.Konopnickiej, Oddział Intensywnej Terapii i Anestezjologii

Lodz, , Poland

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Klinika Neonatologii, Instytut Centrum Zdrowia Matki Polki

Lodz, , Poland

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Dziecięcy Szpital Kliniczny im. Prof. dr hab. n. med. Antoniego Gębali w Lublinie

Lublin, , Poland

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Katedra i Klinika Neonatologii AM w Poznaniu

Poznan, , Poland

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II Klinika Chorób Dzieci PAM, Samodzielny Publiczny

Szczecin, , Poland

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Klinika Neonatologii AM w Warszawie

Warsaw, , Poland

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Klinika Niemowlęca, Instytut Pomnik - Centrum Zdrowia Dziecka

Warsaw, , Poland

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Niepubliczny Zakład Opieki Zdrowotnej Salmed s.c.

Łęczna, , Poland

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Pediatric City Hospital #13

Moscow, , Russia

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Morozovsky Pediatric City Hospital

Moscow, , Russia

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St. Petersburg City Outpatient Hospital #45

Saint Petersburg, , Russia

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Saint-Petersburg State Pediatric Medical Academy

Saint Petersburg, , Russia

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St. Petersburg State Pediatric Medical Academy

Saint Petersburg, , Russia

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Pediatric City Hospital #1

Saint Petersburg, , Russia

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Smolensk State Medical Academy

Smolensk, , Russia

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Hospital Juan Canalejo

A Coruña, , Spain

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Hospital Clinic y Maternistat - Barcelona

Barcelona, , Spain

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Hospital Sant Joan de Déu (Barcelona)

Barcelona, , Spain

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Hospital Reina Sofia

Córdoba, , Spain

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Hospital de Cruces

Cruces, , Spain

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Hospital Josep Trueta

Girona, , Spain

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Hospital Virgen de las Nieves

Granada, , Spain

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Hospital de Donostia (San Sebastian)

Guipuzcoa, , Spain

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Hospital Materno Infantil deJaén

Jaén, , Spain

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Hospital General de Jerez

Jerez de la Frontera, , Spain

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Hospital Materno Infantil de Canarias

Las Palmas de Gran Canaria, , Spain

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Hospital Clínico San Carlos

Madrid, , Spain

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Hospital La Paz- Madrid

Madrid, , Spain

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Hospital Severo Ochoa

Madrid, , Spain

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Hospital Materno Infantil/Neumología pediátrica

Málaga, , Spain

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Hospital Central de Asturias

Oviedo, , Spain

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Hospital Clinico de Salamanca

Salamanca, , Spain

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Hospital Universitario de Canarias

Santa Cruz de Tenerife, , Spain

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Hospital Clinico Universitario de Santiago

Santiago de Compostela, , Spain

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Hospital Maternal Virgen del Rocío

Seville, , Spain

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Hospital Virgen Macarena

Seville, , Spain

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Hospital Joan XXIII

Tarragona, , Spain

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Hospital Universitario La Fe Maternidad

Valencia, , Spain

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Hospital Clinico Universitario de Valencia

Valencia, , Spain

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Hospital Xeral-Cíes

Vigo, , Spain

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Mälarsjukhuset

Eskilstuna, , Sweden

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The Queen Silvia Children's Hospital

Gothenburg, , Sweden

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Karolinska University Hospital Solna

Stockholm, , Sweden

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Danderyds Sjukhus

Stockholm, , Sweden

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Uppsala University Hospital

Uppsala, , Sweden

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Hacettepe Üniversitesi İhsan Doğramacı Çocuk Hastanesi Neonatoloji Ünitesi

Ankara, , Turkey (Türkiye)

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Ankara Üniversitesi

Ankara, , Turkey (Türkiye)

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Ege Üniversitesi Tıp Fakültesi

Izmir, , Turkey (Türkiye)

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Dokuz Eylül Üniversitesi Tıp Fakültesi

Izmir, , Turkey (Türkiye)

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Birmingham Heartlands Hospital

Birmingham, , United Kingdom

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Dumfries and Galloway Royal Infirmary

Dumfries, , United Kingdom

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Children's Respiratory Medicine Division of Maternal and Child Health Sciences Ninewells Hospital

Dundee, , United Kingdom

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Medway Maritime Hospital

Gillingham Kent, , United Kingdom

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Princess Anne Hospital

Hants, , United Kingdom

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Claredon Wing, Leeds General Infirmary

Leeds, , United Kingdom

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St James' University Hospital

Leeds, , United Kingdom

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James Cook University Hospital

Middlesbrough, , United Kingdom

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Queen's Medical Centre Nottingham University Hospital

Nottingham, , United Kingdom

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Sheffield Children's Hospital

Sheffield, , United Kingdom

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Royal Hampshire County Hospital

Winchester, , United Kingdom

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Countries

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United States Argentina Australia Austria Brazil Bulgaria Canada Chile Czechia Denmark France Germany Greece Hungary Iceland Israel Italy New Zealand Poland Russia Spain Sweden Turkey (Türkiye) United Kingdom

References

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Carbonell-Estrany X, Simoes EA, Dagan R, Hall CB, Harris B, Hultquist M, Connor EM, Losonsky GA; Motavizumab Study Group. Motavizumab for prophylaxis of respiratory syncytial virus in high-risk children: a noninferiority trial. Pediatrics. 2010 Jan;125(1):e35-51. doi: 10.1542/peds.2008-1036. Epub 2009 Dec 14.

Reference Type RESULT
PMID: 20008423 (View on PubMed)

Other Identifiers

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MI-CP110

Identifier Type: -

Identifier Source: org_study_id