Respiratory Distress Syndrome Clinical Trial
Official title:
Phase 4 Study of Curosurf (Poractant) and Survanta (Beractant) Surfactant Treatment in Very Premature Infants With Respiratory Distress Syndrome.
Approval of surfactant by the FDA in 1989 for the treatment of Respiratory Distress Syndrome
(RDS) in premature infants greatly improved survival rates. Newer surfactants approved by
the FDA were more concentrated and had a more rapid onset of action. The overall efficacy of
newer surfactants appeared similar until in 2004, Ramanathan and colleagues suggested that a
double dose of Curosurf improved survival in infants 25-32 weeks gestational age, compared
to infants treated with Survanta, the most commonly used surfactant preparation in the
United States. While the data was suggestive, it was not clear that the improvement in
survival was reproducible or that Curosurf was responsible for the improved survival rates.
The purpose of this study was to investigate the role of Curosurf in improving lung function
and survival rates and reducing the complications of prematurity in very premature infants <
30 weeks gestational age at birth.
Specific Aims:
- To determine whether there is a sustained difference in the level of respiratory
support during the first 3 days of life in extremely premature infants treated with
Curosurf versus Survanta
- To determine whether Curosurf is associated with a higher incidence of hemodynamically
significant PDA, compared with Survanta
- To determine whether there is a difference in the cerebral blood flow response to
Curosurf versus Survanta
- To determine whether there is a difference in morbidity in very premature infants
treated with Curosurf versus Survanta
We reasoned that if Curosurf was primarily responsible for improved survival rates, compared
with Survanta, then there should be a sustained improvement in respiratory function in the
first three days of life, when the direct pulmonary effects of the surfactant preparations
would be most easily detected. It was also possible that Curosurf and Survanta could have
effects on other systems that could secondarily affect long-term survival of the infant.
These other organ systems would include, but not be limited to, the development of a
hemodynamically significant Patent Ductus Arteriosus, Intraventricular Hemorrhage or
Periventricular Leukomalacia, or Necrotizing Enterocolitis. We propose to examine how
surfactant administration affected the hemodynamic precursors of these common morbidities of
very premature infants.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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