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

2015; Elsevier BV; Volume: 168; Linguagem: Inglês

10.1016/j.jpeds.2015.09.031

1097-6833

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 Asselin, Catherine M. Bendel, Ellen Bendel‐Stenzel, Sherry E. Courtney, Ramasubbareddy Dhanireddy, Mark L. Hudak, Frances R. Koch, Dennis E. Mayock, Victor McKay, T. Michael O’Shea, Nicolas Porta, Rajan Wadhawan, Lisa Palermo, Sean Strong, Jill Immamura-Ching, Margaret Orfanos-Villalobos, Craig Williams, Douglas J. Horton, Lori Pacello, Alice Willard, Cheryl Gauldin, Anne Holmes, Peggy Johnson, Kerri A. Meinert, Anne Marie Reynolds, Janine Lucie, Patricia L. Conway, Michael Sacilowski, Michael Leadersdorff, Pam Orbank, Karen Wynn, M. DeUngria, Javed Masood Khan, K J Hamann, Molly Schau, B. Hopkins, J. Brunn Jenson, César Bertoldo, Jaffer A. Shariff, Rose McGovern, James U. Adelman, A. Combs, Mary Tjersland, Steven Walker, Elizabeth Howland, Jim Longoria, Holly Meo, Georgia E. McDavid, Katrina Burson, Rick Hinojosa, Christopher N. Johnson, Kenneth Miller, Stefanie Rogers, Sharon Wright, K. Barnette, A. Kellum, M. Nicholas Burke, Catherine Hayes, S J D Chadwick, Diantha B. Howard, Caroline Kennedy, Rebecca M. Prince, Beatrice M. Stefanescu, Jennifer Helderman, Kelly Warden, Pam Brown, James D. Griffin, Lisa Conley, Michael Georgieff, Bridget Davern, Maria M. Mills, STEVE RITTER, Carol L. Wagner, D. Fanning, J. Alan Roberson, Andrea Lampland, P. A. Meyers, Angela Brey, Cathy Worwa, Peter H. Dixon, G. Ebert, Charlotte Hejl, M Maxwell, Keith McCullough, Mohamad T. El Abiad, Ajay J. Talati, Sheila Dempsey, Kathy Gammage, Ga Gower, Kaitlyn E. James, Pam LeNoue, SD Bell, D. Bruton, M Beaulieu, Roberta Williams, Robin Barron-Nelson, Sneha K. Taylor, N. Carol Sikes, Gregory J Lowe, B. Proffitt, Cheryl Chapin, Hart Horneman, K J Hamann, Scott D. Kelley, Eric Vittinghoff, Jean Hietpas, L. Denton, Li Wu, Alan H. Jobe, Avroy A. Fanaroff, Traci E. Clemons, Lucio Glantz, David M. Reboussin, Krisa P. Van Meurs, Mark L. Allen, Betty R. Vohr, RA Ballard, P. Ballard, C. Blaisdell, David J. Durand, Dennis M. Black, Eric C. Eichenwald, Roberta L. Keller, Mark C. Mammel, J. Merrill, Elizabeth E. Rogers, Rita M. Ryan, WE Truog, Jason Asselin, Nancy Newton,

Congenital Diaphragmatic Hernia Studies

Objective To 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 design Extremely 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. Results A 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 <26 weeks (70.6%), race, sex, severity of lung disease at enrollment, or comorbidities of prematurity. Survival without BPD did not differ between the treated and control groups at 36 weeks PMA (31.3% vs 31.7%; relative benefit, 0.98; 95% CI, 0.75-1.28; P = .89) or 40 weeks PMA (58.7% vs 54.1%; relative benefit, 1.08; 95% CI, 0.92-1.27; P = .33). There were no between-group differences in serious adverse events, comorbidities of prematurity, or severity of lung disease to 36 weeks. Conclusion Late treatment with up to 5 doses of surfactant in ventilated premature infants receiving inhaled nitric oxide was well tolerated, but did not improve survival without BPD at 36 or 40 weeks. Pulmonary and neurodevelopmental assessments are ongoing. Trial registration ClinicalTrials.gov: NCT01022580.