OBJECTIVE: In a randomized multi-center trial, we demonstrated that inhaled nitric oxide begun between 7 and 21 days and given for 24 days significantly increased survival without bronchopulmonary dysplasia (BPD) in ventilated premature infants weighing <1250 g. Because some preventative BPD treatments are associated with neurodevelopmental impairment, we designed a follow-up study to assess the safety of nitric oxide. STUDY DESIGN: Our hypothesis was that inhaled nitric oxide would not increase neurodevelopmental impairment compared with placebo. We prospectively evaluated neurodevelopmental and growth outcomes at 24 months postmenstrual age in 477 of 535 surviving infants (89%) enrolled in the trial. RESULTS: In the treated group, 109 of 243 children (45%) had neurodevelopmental impairment (moderate or severe cerebral palsy, bilateral blindness, bilateral hearing loss, or score <70 on the Bayley Scales II), compared with 114 of 234 (49%) in the placebo group (relative risk, 0.92; 95% CI, 0.75-1.12; P = .39). No differences on any subcomponent of neurodevelopmental impairment or growth variables were found between inhaled nitric oxide or placebo. CONCLUSIONS:Inhaled nitric oxide improved survival free of BPD, with no adverse neurodevelopmental effects at 2 years of age. Copyright 2010 Mosby, Inc. All rights reserved.
RCT Entities:
OBJECTIVE: In a randomized multi-center trial, we demonstrated that inhaled nitric oxide begun between 7 and 21 days and given for 24 days significantly increased survival without bronchopulmonary dysplasia (BPD) in ventilated premature infants weighing <1250 g. Because some preventative BPD treatments are associated with neurodevelopmental impairment, we designed a follow-up study to assess the safety of nitric oxide. STUDY DESIGN: Our hypothesis was that inhaled nitric oxide would not increase neurodevelopmental impairment compared with placebo. We prospectively evaluated neurodevelopmental and growth outcomes at 24 months postmenstrual age in 477 of 535 surviving infants (89%) enrolled in the trial. RESULTS: In the treated group, 109 of 243 children (45%) had neurodevelopmental impairment (moderate or severe cerebral palsy, bilateral blindness, bilateral hearing loss, or score <70 on the Bayley Scales II), compared with 114 of 234 (49%) in the placebo group (relative risk, 0.92; 95% CI, 0.75-1.12; P = .39). No differences on any subcomponent of neurodevelopmental impairment or growth variables were found between inhaled nitric oxide or placebo. CONCLUSIONS: Inhaled nitric oxide improved survival free of BPD, with no adverse neurodevelopmental effects at 2 years of age. Copyright 2010 Mosby, Inc. All rights reserved.
Authors: Philip L Ballard; Jeffrey D Merrill; William E Truog; Rodolfo I Godinez; Marye H Godinez; Theresa M McDevitt; Yue Ning; Sergio G Golombek; Lance A Parton; Xianqun Luan; Avital Cnaan; Roberta A Ballard Journal: Pediatrics Date: 2007-08 Impact factor: 7.124
Authors: Roberta A Ballard; William E Truog; Avital Cnaan; Richard J Martin; Philip L Ballard; Jeffrey D Merrill; Michele C Walsh; David J Durand; Dennis E Mayock; Eric C Eichenwald; Donald R Null; Mark L Hudak; Asha R Puri; Sergio G Golombek; Sherry E Courtney; Dan L Stewart; Stephen E Welty; Roderic H Phibbs; Anna Maria Hibbs; Xianqun Luan; Sandra R Wadlinger; Jeanette M Asselin; Christine E Coburn Journal: N Engl J Med Date: 2006-07-27 Impact factor: 91.245
Authors: Krisa P Van Meurs; Linda L Wright; Richard A Ehrenkranz; James A Lemons; M Bethany Ball; W Kenneth Poole; Rebecca Perritt; Rosemary D Higgins; William Oh; Mark L Hudak; Abbot R Laptook; Seetha Shankaran; Neil N Finer; Waldemar A Carlo; Kathleen A Kennedy; Jon H Fridriksson; Robin H Steinhorn; Gregory M Sokol; G Ganesh Konduri; Judy L Aschner; Barbara J Stoll; Carl T D'Angio; David K Stevenson Journal: N Engl J Med Date: 2005-07-07 Impact factor: 91.245
Authors: William E Truog; Philip L Ballard; Michael Norberg; Sergio Golombek; Rashmin C Savani; Jeffrey D Merrill; Lance A Parton; Avital Cnaan; Xianqun Luan; Roberta A Ballard Journal: Pediatrics Date: 2007-04 Impact factor: 7.124
Authors: C L Huddy; C C Bennett; P Hardy; D Field; D Elbourne; R Grieve; A Truesdale; K Diallo Journal: Arch Dis Child Fetal Neonatal Ed Date: 2008-03-28 Impact factor: 5.747
Authors: Michael D Schreiber; Karen Gin-Mestan; Jeremy D Marks; Dezheng Huo; Grace Lee; Pimol Srisuparp Journal: N Engl J Med Date: 2003-11-27 Impact factor: 91.245
Authors: Susan R Hintz; Krisa P Van Meurs; R Perritt; W Kenneth Poole; Abhik Das; David K Stevenson; Richard A Ehrenkranz; James A Lemons; Betty R Vohr; Roy Heyne; David O Childers; Myriam Peralta-Carcelen; Anna Dusick; Yvette R Johnson; Brenda Morris; Robert Dillard; Yvonne Vaucher; Jean Steichen; Ira Adams-Chapman; Ganesh Konduri; Gary J Myers; Marissa de Ungria; Jon E Tyson; Rosemary D Higgins Journal: J Pediatr Date: 2007-07 Impact factor: 4.406
Authors: Athena I Patrianakos-Hoobler; Jeremy D Marks; Michael E Msall; Dezheng Huo; Michael D Schreiber Journal: Acta Paediatr Date: 2010-12-01 Impact factor: 2.299
Authors: Michael A Thompson; Rodney D Britt; Ine Kuipers; Alecia Stewart; James Thu; Hitesh C Pandya; Peter MacFarlane; Christina M Pabelick; Richard J Martin; Y S Prakash Journal: Biochim Biophys Acta Date: 2015-06-22
Authors: Shabih U Hasan; Jim Potenziano; Girija G Konduri; Jose A Perez; Krisa P Van Meurs; M Whit Walker; Bradley A Yoder Journal: JAMA Pediatr Date: 2017-11-01 Impact factor: 16.193