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(904) 244-0411

Safety of Sildenafil in Premature Infants at Risk of Bronchopulmonary Dysplasia (20180529)

  • Status
    Accepting Candidates
  • Age
    N/A
  • Sexes
    All
  • Healthy Volunteers
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Description

You are being asked to consider permitting your baby to take part in this research study, because your baby was born prematurely and is at risk for developing a lung disease called bronchopulmonary dysplasia (BPD). We are interested in learning about the safety of a medicine called sildenafil when given to premature babies at risk of BPD. We will share the information gained from this study with other researchers. The study team will record your baby’s sex, date of birth, and other birth information. They will also record your baby’s medical and medication history. Your baby will be in this study for up to 62 days. Your baby may receive study drug for up to 34 days. Your baby will be monitored during the period they receive study drug and for the following 28 days after they stop receiving study drug. Biological samples, like blood, will be collected from your baby at certain times during the study. You can choose not to participate or to withdraw your baby from the study at any time without penalty or loss of benefits to which you or your baby are otherwise entitled. There are risks in this study that are described in this form. Low blood pressure could occur after receiving sildenafil. Your baby’s blood pressure will be checked closely during the study. Full details are included in the risk section of this form. It is possible that babies who get sildenafil have improved breathing and a lower risk for BPD. However, it is possible that there will be no benefit. We hope the information that we learn from this study will help us to take care of premature babies in the future.

Details

Protocol number 1304032

Eligibility

Inclusion Criteria

  1. Documented informed consent from parent or guardian, prior to study procedures

  2. Receiving positive airway pressure (nasal continuous airway pressure, nasal intermittent positive pressure ventilation, or nasal cannula flow > 1LPM) or mechanical ventilation (high frequency or conventional) at time of randomization*

  3. < 29 weeks gestational age at birth

  4. 7-28 (inclusive) days postnatal age at time of randomization Exclusion

  5. Previous enrollment and dosing in NICHD-2015-SIL02 “Safety of Sildenafil in Premature Infants at Risk of Bronchopulmonary Dysplasia”

  6. Previous exposure to sildenafil within 7 days prior to randomization*

  7. Currently receiving vasopressors*

  8. Currently receiving inhaled nitric oxide*

  9. Baseline mean arterial pressure < gestational age (in weeks) plus postnatal age (in weeks) within 24 hours of randomization; e.g. an infant at 25 weeks gestational age and 3 weeks postnatal age with MAP 225 U/L < 72 hours prior to randomization

  10. ALT > 150 U/L < 72 hours prior to randomization 10. Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study

Lead researchers

Participate in a study

Here are some general steps to consider when participating in a research study:

  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.