Breathing Problems in Premature Infants

What we are studying

Premature babies who requiring assistance with breathing from the ventilator at 1 week of age have a high risk of developing bronchopulmonary dysplasia (BPD), which is a condition where premature babies continue to have problems with their breathing and may require a breathing machine and/or oxygen for many more weeks. The purpose of this study is to test if giving additional surfactant will help the lungs of premature babies who were born at less than or equal to 28 weeks’ gestational age who are also receiving inhaled nitric oxide (iNO). Surfactant is a natural compound made in our lungs, and is required for normal breathing and survival. Many premature infants are born with reduced amounts of surfactant and so they are given surfactant medication through the breathing tube immediately after birth and over the first two days of life. Premature infants that continue to require the breathing tube and the mechanical ventilator beyond the first week of life often have problems with the amount or the function of their own natural surfactant. In this research study we are using surfactant beyond the first week of life, in addition to immediately after birth. The administration of surfactant after the first week of life is investigational and has not yet been approved by the FDA. All babies will receive a gas through the breathing tube called Nitric Oxide. Nitric oxide is a natural gas that is also made in the lungs. It opens the blood vessels that go to the lungs and improves development of the preterm lung.

Who we are studying

  • Men and Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • All Ages up to 0

Eligibility Criteria

  • Infants born prematurely
  • On a ventilator (a machine to help the child breathe)

What is involved

  • Collection of airway secretions
  • 5 doses of study treatment
  • Monitoring of the child's status until discharged from the hospital
  • Study visits after discharge will be done when the child has regular doctor visits
  • Phone call follow-ups every 3-4 months between visits until 1 year of age and again at 22-26 months of age

Compensation

$100 at the completion of the 24 month follow-up visit

Contact Information

Study Coordinator
Kelly Warden
Email
kwarden@wakehealth.edu
Phone
336-718-3091

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.