Abstract

This is a multicenter randomized study of multiple dose, exogenous surfactant in full term infants with moderate ventilatory failure who have adverse progression of disease. Infants will be randomized to control and surfactant groups only if they are stable. All treatment after randomization will be administered by individuals blind to assignment. The primary outcome variable will be adverse progression of disease defined by blood gas measures and increased use of ventilary support. The sample size needed to detect a 40% reduction in adverse progression is 206. Support from the GCRC is being sought only for data management.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
2M01RR000044-35A1
Application #
5217800
Study Section
Project Start
Project End
Budget Start
Budget End
Support Year
35
Fiscal Year
1996
Total Cost
Indirect Cost

  Publications

Askie, Lisa M; Darlow, Brian A; Finer, Neil et al. (2018) Association Between Oxygen Saturation Targeting and Death or Disability in Extremely Preterm Infants in the Neonatal Oxygenation Prospective Meta-analysis Collaboration. JAMA 319:2190-2201
Di Fiore, Juliann M; Martin, Richard J; Li, Hong et al. (2017) Patterns of Oxygenation, Mortality, and Growth Status in the Surfactant Positive Pressure and Oxygen Trial Cohort. J Pediatr 186:49-56.e1
Ternullo, Sharon R; Abdolahi, Amir; Williams, Geoffrey C (2017) Study of monotherapy versus combination therapy for tobacco dependence among heavily addicted smokers. J Am Pharm Assoc (2003) 57:77-81.e1
Younge, Noelle; Goldstein, Ricki F; Bann, Carla M et al. (2017) Survival and Neurodevelopmental Outcomes among Periviable Infants. N Engl J Med 376:617-628
Williams, Geoffrey C; Niemiec, Christopher P; Patrick, Heather et al. (2016) Outcomes of the Smoker's Health Project: a pragmatic comparative effectiveness trial of tobacco-dependence interventions based on self-determination theory. Health Educ Res 31:749-759
Archer, Stephanie Wilson; Carlo, Waldemar A; Truog, William E et al. (2016) Improving publication rates in a collaborative clinical trials research network. Semin Perinatol 40:410-417
Ettensohn, David B; Frampton, Mark W; Nichols, Joan E et al. (2016) Human Alveolar Macrophages May Not Be Susceptible to Direct Infection by a Human Influenza Virus. J Infect Dis 214:1658-1665
Phelps, Dale L; Ward, Robert M; Williams, Rick L et al. (2016) Safety and pharmacokinetics of multiple dose myo-inositol in preterm infants. Pediatr Res 80:209-17
Foglia, Elizabeth E; Nolen, Tracy L; DeMauro, Sara B et al. (2015) Short-term Outcomes of Infants Enrolled in Randomized Clinical Trials vs Those Eligible but Not Enrolled. JAMA 313:2377-9
O'Connor, Thomas G; Wang, Hongyue; Moynihan, Jan A et al. (2015) Observed parent-child relationship quality predicts antibody response to vaccination in children. Brain Behav Immun 48:265-73

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