Multicenter randomized controlled trial of the effects of inhaled nitric oxide therapy on gas exchange in children with acute hypoxemic respiratory failure☆,☆☆,★
Section snippets
Patients
The study protocol was approved by the Institutional Review Committee at each participating center based on Food and Drug Administration approval of an Investigational New Drug exemption. Any pediatric patient admitted to 1 of the participating pediatric intensive care units with AHRF of sufficient severity to require intubation and mechanical ventilation was eligible for enrollment pending parental consent. Acute hypoxemic respiratory failure was defined as an OI (mean airway pressure × FiO2 ×
RESULTS
Patients enrolled into this study (n = 108) were randomized to the control group (n = 55) and to the iNO group (n = 53). Age, sex, mode of ventilation, duration of mechanical ventilation before enrollment, Murray score, and pediatric risk of mortality scores were similar between groups at enrollment (Table I). No difference was seen in assignment of patients with each primary diagnostic categories between the control and iNO groups (Table I).
Ventilator settings (FiO2 , PEEP, and mean airway
DISCUSSION
We report the results of a prospective, multicenter, randomized, masked trial of iNO in the management of pediatric AHRF. We found that iNO therapy improved oxygenation in an acute manner in children with severe AHRF as reflected by an increase in the PaO2 /FiO2 ratio and a decrease in the OI in the iNO group early in treatment. Although no difference occurred in the proportion of responders between groups after 72 hours of treatment, 2 subgroups appeared to benefit from iNO treatment. The
Acknowledgements
We acknowledge the support and contributions of Jayvant Deshpande, MD, Ole Georg Vinorum, MD, Thore Henrichsen, MD,Joel E Barbato, Michelle Holecek, RN, MSN, Jade Forlidas, RN, MS, Lori Roberts, RN, Rocky Stone, RCP, RRT, Christine Cassaw, RRT, RCP, IV, Cherry Smith, RRT, Gary R Cutter, PhD, Wendy Dortch, and Todd MacKenzie, PhD.
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Cited by (0)
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Supported by in part by National Institutes of Health SCOR grant (P50HL57144) and the General Clinical Research Centers Program, National Centers for Research Resources (M01 RR00069).
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Reprint requests: Emily L. Dobyns, MD, Section of Pediatric Critical Care Medicine B530, The Children’s Hospital, 1056 E. 19th Ave, Denver, CO 80218.
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0022-3476/99/$8.00 + 0 9/21/96518