Abstract
Objective To assess the efficacy and safety of early, noninvasive inhaled nitric oxide (iNO) therapy in premature newborns who do not require mechanical ventilation. Study design We performed a multicenter randomized trial including 124 premature newborns who required noninvasive supplemental oxygen within the first 72 hours after birth. Newborns were stratified into 3 different groups by birth weight (500-749, 750-999, 1000-1250 g) prior to randomization to iNO (10 ppm) or placebo gas (controls) until 30 weeks postmenstrual age. The primary outcome was a composite of death or bronchopulmonary dysplasia (BPD) at 36 weeks postmenstrual age. Secondary outcomes included the need for and duration of mechanical ventilation, severity of BPD, and safety outcomes. Results There was no difference in the incidence of death or BPD in the iNO and placebo groups (42% vs 40%, P =.86, relative risk = 1.06, 0.7-1.6). BPD severity was not different between the treatment groups. There were no differences between the groups in the need for mechanical ventilation (22% vs 23%; P =.89), duration of mechanical ventilation (9.7 vs 8.4 days; P =.27), or safety outcomes including severe intracranial hemorrhage (3.4% vs 6.2%, P =.68). Conclusions We found that iNO delivered noninvasively to premature infants who have not progressed to early respiratory failure is a safe treatment, but does not decrease the incidence or severity of BPD, reduce the need for mechanical ventilation, or alter the clinical course.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 1104-1108.e1 |
| Journal | Journal of Pediatrics |
| Volume | 165 |
| Issue number | 6 |
| DOIs | |
| State | Published - Dec 1 2014 |
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Keywords
- BPD Bronchopulmonary dysplasia CPAP Continuous positive airway pressure iNO Inhaled nitric oxide NO Nitric oxide PH Pulmonary hypertension PMA Postmenstrual age
ASJC Scopus subject areas
- Pediatrics, Perinatology, and Child Health
Cite this
Noninvasive inhaled nitric oxide does not prevent bronchopulmonary dysplasia in premature newborns. / Kinsella, John P.; Cutter, Gary R.; Steinhorn, Robin H; Nelin, Leif D.; Walsh, William F.; Finer, Neil N.; Abman, Steven H.
In: Journal of Pediatrics, Vol. 165, No. 6, 01.12.2014, p. 1104-1108.e1.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Noninvasive inhaled nitric oxide does not prevent bronchopulmonary dysplasia in premature newborns
AU - Kinsella, John P.
AU - Cutter, Gary R.
AU - Steinhorn, Robin H
AU - Nelin, Leif D.
AU - Walsh, William F.
AU - Finer, Neil N.
AU - Abman, Steven H.
PY - 2014/12/1
Y1 - 2014/12/1
N2 - Objective To assess the efficacy and safety of early, noninvasive inhaled nitric oxide (iNO) therapy in premature newborns who do not require mechanical ventilation. Study design We performed a multicenter randomized trial including 124 premature newborns who required noninvasive supplemental oxygen within the first 72 hours after birth. Newborns were stratified into 3 different groups by birth weight (500-749, 750-999, 1000-1250 g) prior to randomization to iNO (10 ppm) or placebo gas (controls) until 30 weeks postmenstrual age. The primary outcome was a composite of death or bronchopulmonary dysplasia (BPD) at 36 weeks postmenstrual age. Secondary outcomes included the need for and duration of mechanical ventilation, severity of BPD, and safety outcomes. Results There was no difference in the incidence of death or BPD in the iNO and placebo groups (42% vs 40%, P =.86, relative risk = 1.06, 0.7-1.6). BPD severity was not different between the treatment groups. There were no differences between the groups in the need for mechanical ventilation (22% vs 23%; P =.89), duration of mechanical ventilation (9.7 vs 8.4 days; P =.27), or safety outcomes including severe intracranial hemorrhage (3.4% vs 6.2%, P =.68). Conclusions We found that iNO delivered noninvasively to premature infants who have not progressed to early respiratory failure is a safe treatment, but does not decrease the incidence or severity of BPD, reduce the need for mechanical ventilation, or alter the clinical course.
AB - Objective To assess the efficacy and safety of early, noninvasive inhaled nitric oxide (iNO) therapy in premature newborns who do not require mechanical ventilation. Study design We performed a multicenter randomized trial including 124 premature newborns who required noninvasive supplemental oxygen within the first 72 hours after birth. Newborns were stratified into 3 different groups by birth weight (500-749, 750-999, 1000-1250 g) prior to randomization to iNO (10 ppm) or placebo gas (controls) until 30 weeks postmenstrual age. The primary outcome was a composite of death or bronchopulmonary dysplasia (BPD) at 36 weeks postmenstrual age. Secondary outcomes included the need for and duration of mechanical ventilation, severity of BPD, and safety outcomes. Results There was no difference in the incidence of death or BPD in the iNO and placebo groups (42% vs 40%, P =.86, relative risk = 1.06, 0.7-1.6). BPD severity was not different between the treatment groups. There were no differences between the groups in the need for mechanical ventilation (22% vs 23%; P =.89), duration of mechanical ventilation (9.7 vs 8.4 days; P =.27), or safety outcomes including severe intracranial hemorrhage (3.4% vs 6.2%, P =.68). Conclusions We found that iNO delivered noninvasively to premature infants who have not progressed to early respiratory failure is a safe treatment, but does not decrease the incidence or severity of BPD, reduce the need for mechanical ventilation, or alter the clinical course.
KW - BPD Bronchopulmonary dysplasia CPAP Continuous positive airway pressure iNO Inhaled nitric oxide NO Nitric oxide PH Pulmonary hypertension PMA Postmenstrual age
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U2 - 10.1016/j.jpeds.2014.06.018
DO - 10.1016/j.jpeds.2014.06.018
M3 - Article
VL - 165
SP - 1104-1108.e1
JO - Journal of Pediatrics
JF - Journal of Pediatrics
SN - 0022-3476
IS - 6
ER -