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A Clinical Efficacy and Safety Study of SHP607 in Preventing Chronic Lung Disease in Extremely Premature Infants

IDENTIFIERS
Trial Protocol: SHP607-202
Clinicaltrials.gov: NCT03253263
EudraCT: 2018-001393-16
PURPOSE

The purpose of this study is to determine if an investigational drug can reduce the burden of chronic lung disease in extremely premature babies through 12 months corrected age (CA), as compared to extremely premature babies receiving standard neonatal care alone.

Recruiting
US
CA
FI
7+
IL
IT
JP
PT
ES
SE
GB

Trial at a glance

What medical condition is being studied?   Bronchopulmonary dysplasia, Chronic lung disease of prematurity, Intraventricular hemorrhage, Retinopathy of Prematurity (ROP)
What is the trial testing?   SHP607
How many participants are being enrolled?   477
When is the trial being conducted?    - 
How long is participation in the trial?   The total study period will last approximately 15-17 months depending on the participant\'s GA at birth. Participants enrolled in this study will be asked to participate in a 4-year extension study to evaluate the long-term safety and clinical outcomes of treatment with the study drug.

Key requirements

Sex   
All
Age   
Up to 1 Day
Accepts Healthy Volunteers?   
No

Trial Details / Participation Requirements

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Trial Phase:   Phase 2
Trial Type:   Interventional
Trial Arms/Groups or Cohorts:   
SHP607 250 mcg/kg/24 hours: Participants will receive continuous intravenous (IV) infusion of SHP607 250 micrograms per kilogram per 24 hours (mcg/kg/24 hours) from birth up to postmenstrual age (PMA) 29 weeks +6 days.
SHP607 400 mcg/kg/24 hours: Participants will receive continuous IV infusion of SHP607 400 mcg/kg/24 hours through from birth up to PMA 29 weeks +6 days.
Standard Neonatal Care: Standard neonatal care alone will be provided.
Intervention:   SHP607
Primary Outcome Measure(s):
Time to Final Weaning off Respiratory Technology Support (RTS) From Day 1 Through 12 Months Corrected age (CA) [Time Frame: Baseline through 12 months Corrected Age (CA)]
Secondary Outcome Measure(s):   
Incidence of Bronchopulmonary Dysplasia (BPD) or Death through Postmenstrual age (PMA) 36 Weeks [Time Frame: Baseline through 36 weeks postmenstrual age (PMA)]
Total Number of Days on Respiratory Technology Support (RTS) From Birth Through 12 Months Corrected age (CA) [Time Frame: Birth through 12 months CA]
Duration of Re-hospitalizations [Time Frame: From neonatal intensive care unit (NICU) discharge through 12 months CA]
Number of Emergency Room Visits [Time Frame: From NICU discharge through 12 months CA]
Number of Days of Respiratory Medication use [Time Frame: From NICU discharge through 12 months CA]
Incidence of Signs and Symptoms of Respiratory Disease as Assessed by a 28-day Caregiver-administered Diary Ending at 12 Months Corrected age (CA) [Time Frame: 11 months CA through 12 months CA]
Incidence of Chronic Respiratory Morbidity (CRM1) Through 12 Months Corrected age (CA) [Time Frame: From NICU discharge through 12 months CA]
Incidence of Chronic Respiratory Morbidity Including Symptoms of Respiratory Disease (CRM2) Through 12 Months Corrected age (CA) [Time Frame: From NICU discharge through 12 months CA]
Severity of Chronic Respiratory Morbidity (CRM3) Through 12 Months Corrected age (CA), as Determined by the Chronic Lung Disease (CLD) of Infancy Severity Score [Time Frame: From NICU discharge through 12 months CA]
Incidence of Intraventricular Haemorrhage (IVH) Through Postmenstrual age (PMA) 40 weeks, as Assessed by Cranial Ultrasound [Time Frame: Baseline through 40 Weeks PMA]
Motor Function at 12 Months Corrected age (CA), as Measured by Alberta Infant Motor Scales (AIMS) [Time Frame: At 12 months CA]
Functional Status as Assessed by PREMature Infant Index (PREMII) at Postmenstrual Age (PMA) 36 Weeks [Time Frame: At 36 weeks PMA]
Incidence of Retinopathy of Prematurity (ROP) [Time Frame: 31 weeks through 40 weeks PMA]
Incidence of Mortality [Time Frame: From birth through 12 months CA]
Exposure-response of Insulin-like Growth Factor-1 (IGF-1) [Time Frame: Up to 12 months CA]
Entry Criteria:
Must be newborn preterm infant with gestational age (GA) of 23 weeks +0 days and 27 weeks +6 days. Enrollment into the study has to occur 24 hours after birth. Cannot have known or suspected chromosomal abnormality, genetic disorder, or syndrome.

Trial Locations

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RESULTS
University of South Alabama Children's and Women's Hospital

1700 Center St, Mobile, AL 36604, USA

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Arkansas Children's Hospital

1 Children's Way, Little Rock, AR 72202, USA

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University of Arkansas for Medical Sciences

4301 W Markham St, Little Rock, AR 72205, USA

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LAC USC Medical Center

2051 Marengo St, Los Angeles, CA 90033, USA

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David Geffen School of Medicine at UCLA

10833 Le Conte Ave, Los Angeles, CA 90095, USA

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Tampa General Hospital

1 Tampa General Cir, Tampa, FL 33606, USA

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University of Illinois at Chicago

1200 W Harrison St, Chicago, IL 60607, USA

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Memorial Hospital of South Bend

615 N Michigan St, South Bend, IN 46601, USA

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Ochsner Baptist Medical Center

2700 Napoleon Ave, New Orleans, LA 70115, USA

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Floating Hospital for Children

755 Washington St, Boston, MA 02111, USA

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University of Mississippi Medical Center

2500 N State St, Jackson, MS 39216, USA

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Bristol Myers Squibb Children's Hospital at Robert Wood Johnson University Hospital

200 Somerset St, New Brunswick, NJ 08901, USA

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Vidant Medical Center

2100 Stantonsburg Rd, Greenville, NC 27834, USA

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University of Oklahoma Health Sciences Center

865 Research Pkwy, Oklahoma City, OK 73104, USA

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Medical University of South Carolina Children Hospital

171 Ashley Ave, Charleston, SC 29425, USA

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Virginia Commonwealth University - Children's Hospital of Richmond at VCU

1000 E Broad St, Richmond, VA 23219, USA

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Sainte Justine Hospital

3175 Chemin de la Côte-Sainte-Catherine, Montréal, QC H3T 1C5, Canada

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Mount Sinai Hospital

600 University Ave, Toronto, ON M5G 1X5, Canada

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Oulun Yliopistollinen Sairaala

Kajaanintie 50, 90220 Oulu, Finland

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Bnai Zion Medical Center

Sderot Eliyahu Golomb 47, Haifa, Israel

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Fondazione Policlinico Universitario A Gemelli

Via Giuseppe Moscati, 31, 00168 Roma RM, Italy

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Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Via della Commenda, 10, 20122 Milano MI, Italy

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Azienda Ospedaliera Di Padova

Via Nicolò Giustiniani, 2, 35128 Padova PD, Italy

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Azienda Ospedaliero-Universitaria Careggi SOD Neonatologia e Terapia Intensiva Neonatale

Largo Piero Palagi, 1, 50139 Firenze FI, Italy

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Istituto Giannina Gaslini-Istituto Pediatrico di Ricovero e

Via Gerolamo Gaslini, 5, 16147 Genova GE, Italy

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Presidio Ospedaliero Di Treviso Ca' Foncello

Piazzale dell'Ospedale, 1, 31100 Treviso TV, Italy

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Kagoshima City Hospital

37-1 Uearatachō, Kagoshima, 890-8760, Japan

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Nagano Children's Hospital

3100 Toyoshina, Azumino, Nagano 399-8205, Japan

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Kurashiki Central Hospital

1-chōme-1-1 Miwa, Kurashiki, Okayama 710-8602, Japan

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Saitama Medical Center

1981番地 Kamoda, Kawagoe, Saitama 350-8550, Japan

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Osaka Women's and Children's Hospital

840 Murodōchō, Izumi, Osaka 594-1101, Japan

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Hospital Garcia de Orta

Av. Torrado da Silva, 2805-267 Almada, Portugal

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Maternidade Alfredo da Costa

R. Viriato 1, 2890-495 Lisboa, Portugal

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Centro Hospitalar Lisboa

Av. Prof. Egas Moniz MB, 1649-028 Lisboa, Portugal

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Centro Materno Infantil do Norte - Centro Hospital Universitario do Porto, E.P.E.

Largo da Maternidade de Júlio Dinis 45, 4050-651 Porto, Portugal

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Hospital Clinico Unversitario de Santiago

Rúa da Choupana, s/n, 15706 Santiago de Compostela, A Coruña, Spain

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Hospital General Universitario de Alicante

Pintor Baeza, 11, 03010 Alacant, Alicante, Spain

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Hospital Unversitari de Tarragona Joan XXIII

C/ Dr. Mallafrè Guasch, 4, 43005 Tarragona, Spain

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Skanes Universitetssjukhus

Entrégatan 7, 222 42 Lund, Sweden

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Karolinska Solna

Karolinska Vägen, Solna, Sweden

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Norfolk and Norwich University Hospital

Norfolk & Norwich University Hospital, Colney Ln, Colney, Norwich NR4 7UY, UK

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Ashford and St. Peter's Hospitals NHS Trust - St. Peter's Hospital

Guildford St, Lyne, Chertsey KT16 0PZ, UK

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University of Cambridge

The Old Schools, Trinity Ln, Cambridge CB2 1TN, UK

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University College London

Gower St, Bloomsbury, London WC1E 6BT, UK

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Chelsea and Westminster NHS Trust

369 Fulham Rd, London SW10 9NH, UK

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St. Mary's Hospital

Oxford Rd, Manchester M13 9WL, UK

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Wayne State University Children's Hospital of Michigan

3901 Beaubien St, Detroit, MI 48201, USA

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Wayne State University Hutzel Women's Hospital

3990 John R St, Detroit, MI 48201, USA

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Jersey Shore University Medical Center

1945 NJ-33, Neptune City, NJ 07753, USA

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West Virginia University

Morgantown, WV 26506, USA

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Aurora Sinai Medical Center

945 N 12th St, Milwaukee, WI 53233, USA

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View all (51)
Trial Protocol ID: SHP607-202
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