ClinicalTrials.gov
ClinicalTrials.gov Menu

Preventing Chronic Lung Disease in Extremely Premature Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03253263
Recruitment Status : Not yet recruiting
First Posted : August 17, 2017
Last Update Posted : May 21, 2018
Sponsor:
Information provided by (Responsible Party):
Shire

Brief Summary:
The purpose of this study is to determine if an investigational drug can reduce respiratory complications in extremely premature babies through 12 months corrected age (CA), as compared to extremely premature babies receiving standard neonatal care alone

Condition or disease Intervention/treatment Phase
Retinopathy of Prematurity (ROP) Intraventricular Hemorrhage Bronchopulmonary Dysplasia Chronic Lung Disease of Prematurity Drug: SHP607 Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1053 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase 2b/3, Multicenter, Randomized, Open-label, Controlled, 3-Arm Study to Evaluate the Clinical Efficacy and Safety of SHP607 in Preventing Chronic Lung Disease Through 12 Months Corrected Age (CA) Compared to Standard Neonatal Care in Extremely Premature Infants
Estimated Study Start Date : November 29, 2018
Estimated Primary Completion Date : March 30, 2022
Estimated Study Completion Date : March 30, 2022


Arm Intervention/treatment
Experimental: SHP607 250 mcg/kg/24 hours
Participants will receive SHP607 at a dose of 250 microgram (mcg)/kg/24 hours through continuous intravenous (IV) infusion from birth up to postmenstrual age (PMA) 29 weeks +6 days.
Drug: SHP607
Intravenous infusion of SHP607 at doses of 250 mcg/kg/24 hours and 400 mcg/kg/24 hours from birth up to PMA 29 weeks + 6 days.
Other Name: Mecasermin Rinfabate

Experimental: SHP607 400 mcg/kg/24 hours
Participants will receive SHP607 at a dose of 400 mcg/kg/24 hours through continuous IV infusion from birth up to PMA 29 weeks +6 days.
Drug: SHP607
Intravenous infusion of SHP607 at doses of 250 mcg/kg/24 hours and 400 mcg/kg/24 hours from birth up to PMA 29 weeks + 6 days.
Other Name: Mecasermin Rinfabate

No Intervention: Standard Neonatal Care
Neonatal care alone will be provided.



Primary Outcome Measures :
  1. Incidence of Chronic Respiratory Morbidity (CRM) Through 12 Months Corrected Age (CA) [ Time Frame: Baseline through 12 Months Corrected Age (CA) ]
    CRM is a common adverse outcome of premature birth resulting in recurrent respiratory symptoms requiring treatment with pulmonary medications such as bronchodilators, need for supplementary home oxygen, frequent emergency room visits or hospital readmissions, especially during the first year of life. CRM will be measured by respiratory health care utilization and respiratory symptoms.


Secondary Outcome Measures :
  1. Incidence of Bronchopulmonary Dysplasia (BPD) at Postmenstrual Age (PMA) 36 Weeks [ Time Frame: PMA Week 36 ]
    BPD is a chronic lung disorder characterized by pulmonary immaturity, undifferentiated alveoli with the presence of hyaline membrane and atelectasis, dilated capillaries immersed in the mesenchyme, and a distorted deposition of the extracellular matrix. BPD results in residual effects on pulmonary function and is linked to neurodevelopmental problems during later childhood.

  2. Incidence of Severe Intraventricular Hemorrhage (IVH) Grade III or IV Through Postmenstrual Age (PMA) 40 Weeks [ Time Frame: Baseline Through PMA 40 Weeks ]
    IVH is characterized by hemorrhage into the germinal matrix tissues of the developing brain. IVH is associated with substantial mortality and morbidity and may result in long-term neurodevelopmental impairments. It has been attributed to changes in cerebral blood flow to the immature germinal matrix microvasculature and secondary periventricular venous infarction. It will be assessed by cerebral ultrasound.

  3. Incidence of Bronchopulmonary Dysplasia (BPD) at Postmenstrual Age (PMA) 40 Weeks [ Time Frame: PMA Week 40 ]
    BPD is a chronic lung disorder characterized by pulmonary immaturity, undifferentiated alveoli with the presence of hyaline membrane and atelectasis, dilated capillaries immersed in the mesenchyme, and a distorted deposition of the extracellular matrix. BPD results in residual effects on pulmonary function and is linked to neurodevelopmental problems during later childhood.

  4. Incidence of Chronic Respiratory Morbidity (CRM) or Death Through 6 Months Corrected Age (CA) [ Time Frame: Baseline through 6 Months Corrected Age (CA) ]
    CRM is a common adverse outcome of premature birth resulting in recurrent respiratory symptoms requiring treatment with pulmonary medications such as bronchodilators, need for supplementary home oxygen, frequent emergency room visits or hospital readmissions, especially during the first year of life. CRM will be measured by respiratory health care utilization and respiratory symptoms.

  5. Functional Status as Assessed by PREMature Infant Index (PREMII) at Postmenstrual Age (PMA) 40 Weeks [ Time Frame: PMA Week 36 ]
    PREMII is a Clinician-Reported Outcome (ClinRO) assessment used to capture overall functional maturation of extremely preterm neonates. Functional Status is defined as what the infant can do with respect to 8 key functional areas (feeding, weight gain, thermoregulation, respiratory support, apnea, bradycardia, desaturation events, and oxygen administration), as a reflection of the infant's overall health and development.

  6. Incidence of Retinopathy of Prematurity (ROP) [ Time Frame: PMA Week 31 up to Week 40 ]
    The ROP examination will consist of a dilated fundus examination. Typically ROP is classified according to the International Classification (International Committee for the Classification of Retinopathy of Prematurity 2005) and is subdivided into Stage 1 (demarcation line), Stage 2 (ridge), Stage 3 (ridge with extraretinal fibrovascular proliferations), Stage 4 (subtotal retinal detachment), and Stage 5 (total retinal detachment).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   23 Weeks to 27 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. A signed and dated written informed consent from the subject's parents/guardians prior to any study-related procedures that has been approved by the institutional review board (IRB)/independent ethics committee (IEC).
  2. Subject must be between gestational age (GA) of 23 weeks +0 days and 27 weeks +6 days.

Exclusion Criteria:

  1. Detectable gross malformation.
  2. Known or suspected chromosomal abnormality, genetic disorder, or syndrome, according to the investigator's opinion.
  3. Persistent blood glucose level less than (<)2.5 millimoles per liter (mmol/L) at the Baseline Visit to exclude severe congenital abnormalities of glucose metabolism.
  4. Clinically significant neurological disease according to the investigator's opinion (grade I intraventricular hemorrhage (IVH) allowed).
  5. Any other condition or therapy that, in the investigator's opinion, may pose a risk to the subject or interfere with the subject's ability to be compliant with this protocol or interfere with interpretation of results.
  6. Monozygotic multiples (dizygotic multiples allowed).
  7. Subject is participating or plans to participate in a clinical study of another investigational study drug, device, or procedure (participation in observational studies is permitted on a case-by-case basis).
  8. The subject or subject's parent or legally authorized representative(s) is unable to comply with the protocol or is unlikely to be available for long-term follow-up as determined by the investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03253263


Contacts
Contact: Shire Contact 1-866-842-5335 ClinicalTransparency@shire.com

Sponsors and Collaborators
Shire
Investigators
Study Director: Shire Physician Shire

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT03253263     History of Changes
Other Study ID Numbers: SHP607-301
First Posted: August 17, 2017    Key Record Dates
Last Update Posted: May 21, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Retinopathy of Prematurity
Retinal Diseases
Hemorrhage
Lung Diseases
Premature Birth
Bronchopulmonary Dysplasia
Cerebral Hemorrhage
Pathologic Processes
Respiratory Tract Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Ventilator-Induced Lung Injury
Lung Injury
Infant, Premature, Diseases
Infant, Newborn, Diseases
Eye Diseases
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases