A Clinical Efficacy and Safety Study of SHP607 in Preventing Chronic Lung Disease in Extremely Premature Infants
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.
Conditions
- Retinopathy of Prematurity (ROP)
- Intraventricular Hemorrhage
- Bronchopulmonary Dysplasia
- Chronic Lung Disease of Prematurity
Eligibility
- Eligible Ages
- Under 1 Day
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Written informed consents and/or assents must be signed and dated by the participant's parent(s) prior to any study related procedures. The informed consent and any assents for underage parents must be approved by the institutional review board (IRB)/independent ethics committee (IEC). 2. Written informed consents and/or assents must be signed and dated by the participant's birth mother prior to providing study-related information related to birth mother medical history, pregnancy and the birth of the participant. The informed consent and any assents for underage birth mothers must be approved by the IRB/IEC. 3. Initially, participants must be between gestational age (GA) of 26 weeks +0 days and 27 weeks +6 days, inclusive. After approximately 75 participants (approximately 25 participants in each treatment group) have completed the postmenstrual age (PMA) 40 weeks visit, an independent data monitoring committee (DMC) will assess safety data and may authorize enrollment of participants of GA between 23 weeks +0 days and 27 weeks +6 days, inclusive.
Exclusion Criteria
- Detectable major (or severe) congenital malformation identified before randomization. 2. Known or suspected chromosomal abnormality, genetic disorder, or syndrome, identified before randomization, according to the investigator's opinion. 3. Hypoglycemia at Baseline (blood glucose less than (<) 45 milligrams per deciliter [mg/dL] or 2.5 milli moles per liter [mmol/L]) which persists in spite of glucose supplementation, to exclude severe congenital abnormalities of glucose metabolism. 4. Clinically significant neurological disease identified before randomization according to cranial ultrasound (hemorrhages confined to the germinal matrix are allowed) and investigator's opinion. 5. Any other condition or therapy that, in the investigator's opinion, may pose a risk to the participant or interfere with the participant's potential compliance with this protocol or interfere with interpretation of results. 6. Current or planned participation in a clinical study of another investigational study drug, device, or procedure (participation in observational studies is permitted on a case-by-case basis). 7. The participant or participant's parent(s) is/are unable to comply with the protocol or is unlikely to be available for long-term follow-up as determined by the investigator.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental 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. |
|
Experimental 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. |
|
No Intervention Standard Neonatal Care |
Standard neonatal care alone will be provided. |
|
Recruiting Locations
University of South Alabama Children's and Women's Hospital
Mobile, Alabama 36604
Mobile, Alabama 36604
Contact:
Site Contact
251-415-1055; 251-451-1270
Site Contact
251-415-1055; 251-451-1270
Arkansas Children's Hospital
Little Rock, Arkansas 72202-3500
Little Rock, Arkansas 72202-3500
Contact:
Site Contact
501-364-2596
Site Contact
501-364-2596
University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
Contact:
Site Contact
501-526-7984
Site Contact
501-526-7984
David Geffen School of Medicine at UCLA
Los Angeles, California 90095
Los Angeles, California 90095
Contact:
Site Contact
310-794-8864; 310-825-9330
Site Contact
310-794-8864; 310-825-9330
Tampa General Hospital
Tampa, Florida 33606
Tampa, Florida 33606
Contact:
Site Contact
813-844-3437
Site Contact
813-844-3437
University of Illinois at Chicago
Chicago, Illinois 60612
Chicago, Illinois 60612
Contact:
Site Contact
312-355-4038
Site Contact
312-355-4038
Memorial Hospital of South Bend
South Bend, Indiana 46601
South Bend, Indiana 46601
Contact:
Site Contact
574-647-3048
Site Contact
574-647-3048
Ochsner Baptist Medical Center
New Orleans, Louisiana 70115
New Orleans, Louisiana 70115
Contact:
Site Contact
504-894-2619; 504-842-4832
Site Contact
504-894-2619; 504-842-4832
University of Mississippi Medical Center
Jackson, Mississippi 39216
Jackson, Mississippi 39216
Contact:
Site Contact
601-815-3070
Site Contact
601-815-3070
Jersey Shore University Medical Center
Neptune, New Jersey 07753
Neptune, New Jersey 07753
Contact:
Site Contact
(732) 776-4693, (732) 776-4287
Site Contact
(732) 776-4693, (732) 776-4287
Bristol Myers Squibb Children's Hospital at Robert Wood Johnson University Hospital
New Brunswick, New Jersey 08901
New Brunswick, New Jersey 08901
Contact:
Site Contact
732-235-5691
Site Contact
732-235-5691
Vidant Medical Center
Greenville, North Carolina 27834
Greenville, North Carolina 27834
Contact:
Site Contact
252-744-5368
Site Contact
252-744-5368
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
Oklahoma City, Oklahoma 73104
Contact:
Site Contact
405-271-5215
Site Contact
405-271-5215
Medical University of South Carolina Children Hospital
Charleston, South Carolina 29425
Charleston, South Carolina 29425
Contact:
Site Contact
843-792-8829
Site Contact
843-792-8829
Virginia Commonwealth University - Children's Hospital of Richmond at VCU
Richmond, Virginia 23219
Richmond, Virginia 23219
Contact:
Site Contact
804-828-9602; 804-628-3921
Site Contact
804-828-9602; 804-628-3921
West Virginia University
Morgantown, West Virginia 26506
Morgantown, West Virginia 26506
Aurora Sinai Medical Center
Milwaukee, Wisconsin 53233
Milwaukee, Wisconsin 53233
Contact:
Site Contact
414-828-3708
Site Contact
414-828-3708
More Details
- NCT ID
- NCT03253263
- Status
- Recruiting
- Sponsor
- Shire