Monika M Gadhia1, Gary R Cutter2, Steven H Abman3, John P Kinsella4. 1. Division of Neonatology, Department of Pediatrics, Weill Cornell Medical College, New York, NY. Electronic address: Mog9018@med.cornell.edu. 2. Department of Biostatistics, University of Alabama, Birmingham, AL. 3. Pediatric Heart Lung Center, University of Colorado School of Medicine, Aurora, CO; Section of Pulmonary Medicine, Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO. 4. Pediatric Heart Lung Center, University of Colorado School of Medicine, Aurora, CO; Section of Neonatology, Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO.
Abstract
OBJECTIVE: To assess whether the combination of early inhaled nitric oxide (iNO) therapy and vitamin A supplementation lowers the incidence of bronchopulmonary dysplasia (BPD) in premature newborns with respiratory failure. STUDY DESIGN: A total of 793 mechanically ventilated infants (birth weight 500-1250 g) were randomized (after stratification by birth weight) to receive placebo or iNO (5 ppm) for 21 days or until extubation (500-749, 750-999, or 1000-1250 g). A total of 398 newborns received iNO, and of these, 118 (30%) receivedvitamin A according to their enrollment center. We compared patients who received iNO + vitamin A with those who received iNO alone. The primary outcome was a composite of death or BPD at 36 weeks postconceptual age. RESULTS:BPD was reduced in infants who received iNO + vitamin A for the 750-999 g birth weight group compared with iNO alone (P = .01). This group also showed a reduction in the combined outcome of BPD + death compared with iNO alone (P = .01). The use of vitamin A did not change the risk for BPD in the placebo group. Overall, the use of vitamin A was low (229 of 793 patients, or 29%). Combined therapy improved Bayley Scales of Infant Development II Mental and Psychomotor Developmental Index scores at 1 year compared with infants treated solely with iNO for the 500-749 g birth weight group. CONCLUSIONS: In this retrospective analysis of the nonrandomized use of vitamin A, combined iNO + vitamin A therapy in preterm infants with birth weight 750-999 g reduced the incidence of BPD and BPD + death and improved neurocognitive outcomes at 1 year in the 500-749 g birth weight group.
RCT Entities:
OBJECTIVE: To assess whether the combination of early inhaled nitric oxide (iNO) therapy and vitamin A supplementation lowers the incidence of bronchopulmonary dysplasia (BPD) in premature newborns with respiratory failure. STUDY DESIGN: A total of 793 mechanically ventilated infants (birth weight 500-1250 g) were randomized (after stratification by birth weight) to receive placebo or iNO (5 ppm) for 21 days or until extubation (500-749, 750-999, or 1000-1250 g). A total of 398 newborns received iNO, and of these, 118 (30%) received vitamin A according to their enrollment center. We compared patients who received iNO + vitamin A with those who received iNO alone. The primary outcome was a composite of death or BPD at 36 weeks postconceptual age. RESULTS: BPD was reduced in infants who received iNO + vitamin A for the 750-999 g birth weight group compared with iNO alone (P = .01). This group also showed a reduction in the combined outcome of BPD + death compared with iNO alone (P = .01). The use of vitamin A did not change the risk for BPD in the placebo group. Overall, the use of vitamin A was low (229 of 793 patients, or 29%). Combined therapy improved Bayley Scales of Infant Development II Mental and Psychomotor Developmental Index scores at 1 year compared with infants treated solely with iNO for the 500-749 g birth weight group. CONCLUSIONS: In this retrospective analysis of the nonrandomized use of vitamin A, combined iNO + vitamin A therapy in preterm infants with birth weight 750-999 g reduced the incidence of BPD and BPD + death and improved neurocognitive outcomes at 1 year in the 500-749 g birth weight group.
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