A Clinical Efficacy and Safety Study of SHP607 in Preventing Chronic Lung Disease in Extremely Premature Infants
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.
- Retinopathy of Prematurity (ROP)
- Intraventricular Hemorrhage
- Bronchopulmonary Dysplasia
- Chronic Lung Disease of Prematurity
- Eligible Ages
- Under 1 Day
- Eligible Genders
- Accepts Healthy Volunteers
- 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).
- 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.
- 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.
- Detectable major (or severe) congenital malformation identified before randomization.
- Known or suspected chromosomal abnormality, genetic disorder, or syndrome, identified before randomization, according to the investigator's opinion.
- 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.
- Clinically significant neurological disease identified before randomization according to cranial ultrasound (hemorrhages confined to the germinal matrix are allowed) and investigator's opinion.
- 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.
- 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).
- 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.
- Phase 2
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- None (Open Label)
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.||
Mobile, Alabama 36604
Little Rock, Arkansas 72202-3500
Little Rock, Arkansas 72205
Los Angeles, California 90095
Tampa, Florida 33606
Chicago, Illinois 60612
South Bend, Indiana 46601
New Orleans, Louisiana 70115
Jackson, Mississippi 39216
Neptune, New Jersey 07753
(732) 776-4693, (732) 776-4287
New Brunswick, New Jersey 08901
Oklahoma City, Oklahoma 73104
Charleston, South Carolina 29425
Richmond, Virginia 23219
Morgantown, West Virginia 26506
Milwaukee, Wisconsin 53233
- NCT ID
Study ContactShire Contact
+1 866 842 5335