Randomized Trial of Late Surfactant Treatment in Ventilated Preterm Infants Receiving Inhaled Nitric Oxide

Autor: Roberta A. Ballard, Roberta L. Keller, Dennis M. Black, Philip L. Ballard, Jeffrey D. Merrill, Eric C. Eichenwald, William E. Truog, Mark C. Mammel, Robin H. Steinhorn, Elizabeth E. Rogers, Rita M. Ryan, David J. Durand, Jeanette M. Asselin, Catherine M. Bendel, Ellen M. Bendel-Stenzel, Sherry E. Courtney, Ramasubbareddy Dhanireddy, Mark L. Hudak, Frances R. Koch, Dennis E. Mayock, Victor J. McKay, T. Michael O'Shea, Nicolas F. Porta, Rajan Wadhawan, Lisa Palermo, S. Hamilton Strong, J. Immamura-Ching, M. Orfanos-Villalobos, C. Williams, D. Horton, L. Pacello, A. Willard, C. Gauldin, A. Holmes, P. Johnson, K. Meinert, A.M. Reynolds, J. Lucie, P. Conway, M.l. Sacilowski, M. Leadersdorff, P. Orbank, K. Wynn, M. deUngria, J. Khan, K. Hamann, M. Schau, B. Hopkins, J. Jenson, C. Garcia, J. Shariff, R. McGovern, J. Adelman, A. Combs, M. Tjersland, S. Walker, E. Howland, J. Longoria, H. Meo, G. McDavid, K. Burson, R. Hinojosa, C. Johnson, K. Miller, S. Rogers, S. Wright, K. Barnette, A. Kellum, M. Burke, C. Hayes, S. Chadwick, D. Howard, C. Kennedy, R. Prince, B. Stefanescu, J. Helderman, K. Warden, P. Brown, J. Griffin, L. Conley, M. Georgieff, B. Davern, M. Mills, S. Ritter, C. Wagner, D. Fanning, J. Roberson, A. Lampland, P. Meyers, A. Brey, C. Worwa, P. Dixon, G. Ebert, C. Hejl, M. Maxwell, K. McCullough, M.T. El Abiad, A. Talati, S. Dempsey, K. Gammage, G. Gower, K. James, P. LeNoue, S. Bell, D. Bruton, M. Beaulieu, R. Williams, R. Barron-Nelson, S. Taylor, N.C. Sikes, G. Lowe, B. Proffitt, C. Chapin, H. Horneman, S. Kelley, E. Vittinghoff, J. Hietpas, L. Denton, L. Wu, A. Jobe, A. Fanaroff, T. Clemons, L. Glantz, D. Reboussin, K. Van Meurs, M. Allen, B. Vohr, R. Ballard, P. Ballard, C. Blaisdell, D. Durand, D. Black, E. Eichenwald, R. Keller, M. Mammel, J. Merrill, E. Rogers, R. Ryan, W. Truog, J. Asselin, N. Newton
Rok vydání: 2016
Předmět:
Male
TOLSURF Study Group
Calfactant
medicine.medical_treatment
Diseases
Infant
Premature
Diseases

Reproductive health and childbirth
Low Birth Weight and Health of the Newborn
Pediatrics
law.invention
0302 clinical medicine
Randomized controlled trial
law
Fraction of inspired oxygen
Infant Mortality
Infant
Very Low Birth Weight

030212 general & internal medicine
Lung
Bronchopulmonary Dysplasia
Pediatric
Respiration
Gestational age
Survival Rate
Inhalation
Anesthesia
Artificial
Administration
Respiratory
Female
Infant
Premature

medicine.drug
Birth weight
Clinical Trials and Supportive Activities
Nitric Oxide
Article
Neonatal Respiratory Distress
Paediatrics and Reproductive Medicine
03 medical and health sciences
Preterm
Clinical Research
030225 pediatrics
Administration
Inhalation

medicine
Humans
Survival rate
Premature
Mechanical ventilation
business.industry
Very Low Birth Weight
Infant
Newborn

Infant
Pulmonary Surfactants
Human Movement and Sports Sciences
Perinatal Period - Conditions Originating in Perinatal Period
medicine.disease
Newborn
Respiration
Artificial

United States
Bronchopulmonary dysplasia
Pediatrics
Perinatology and Child Health

business
Popis: ObjectiveTo assess whether late surfactant treatment in extremely low gestational age (GA) newborn infants requiring ventilation at 7-14 days, who often have surfactant deficiency and dysfunction, safely improves survival without bronchopulmonary dysplasia (BPD).Study designExtremely low GA newborn infants (GA ≤28 0/7 weeks) who required mechanical ventilation at 7-14 days were enrolled in a randomized, masked controlled trial at 25 US centers. All infants received inhaled nitric oxide and either surfactant (calfactant/Infasurf) or sham instillation every 1-3 days to a maximum of 5 doses while intubated. The primary outcome was survival at 36 weeks postmenstrual age (PMA) without BPD, as evaluated by physiological oxygen/flow reduction.ResultsA total of 511 infants were enrolled between January 2010 and September 2013. There were no differences between the treated and control groups in mean birth weight (701 ± 164 g), GA (25.2 ± 1.2 weeks), percentage born at GA
Databáze: OpenAIRE