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Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
A randomized trial of nasal prong or face mask for respiratory support for preterm newborns.
Pediatrics 2013 August
BACKGROUND AND OBJECTIVE: Resuscitation guidelines recommend that respiratory support should be given to newborns via a face mask (FM) in the delivery room (DR). Respiratory support given to preterm newborns via a single nasal prong (SNP; ie, short nasal tube, nasopharyngeal tube) may be more effective. We wished to determine whether giving respiratory support to preterm newborns with a SNP rather than a FM reduces the rate of intubation in the DR.
METHODS: Infants <31 weeks' gestation were randomized just before delivery to SNP (endotracheal tube shortened to 5 cm) or FM. Randomization was stratified by gestation (<28 weeks, 28-30(+6)). Infants with apnea, respiratory distress, and/or heart rate <100 received positive pressure ventilation with a T-piece. The primary outcome was intubation and mechanical ventilation in the DR. Infants in both groups were intubated for heart rate <100 and/or apnea despite PPV and not solely for surfactant administration. All other aspects of treatment in the DR and NICU were the same. Relevant secondary outcomes were recorded and data were analyzed by using the intention-to-treat principle.
RESULTS: One hundred forty-four infants were enrolled. The rate of intubation in the DR was the same in both groups (11/72 [15%] vs 11/72 [15%], P = 1.000]. Infants assigned to SNP had lower SpO2 at 5 minutes and received a higher maximum concentration of oxygen in the DR. There were no significant differences in other secondary outcomes.
CONCLUSIONS: Giving respiratory support to newborn infants <31 weeks' gestation via a SNP, compared with a FM, did not result in less intubation and ventilation in the DR.
METHODS: Infants <31 weeks' gestation were randomized just before delivery to SNP (endotracheal tube shortened to 5 cm) or FM. Randomization was stratified by gestation (<28 weeks, 28-30(+6)). Infants with apnea, respiratory distress, and/or heart rate <100 received positive pressure ventilation with a T-piece. The primary outcome was intubation and mechanical ventilation in the DR. Infants in both groups were intubated for heart rate <100 and/or apnea despite PPV and not solely for surfactant administration. All other aspects of treatment in the DR and NICU were the same. Relevant secondary outcomes were recorded and data were analyzed by using the intention-to-treat principle.
RESULTS: One hundred forty-four infants were enrolled. The rate of intubation in the DR was the same in both groups (11/72 [15%] vs 11/72 [15%], P = 1.000]. Infants assigned to SNP had lower SpO2 at 5 minutes and received a higher maximum concentration of oxygen in the DR. There were no significant differences in other secondary outcomes.
CONCLUSIONS: Giving respiratory support to newborn infants <31 weeks' gestation via a SNP, compared with a FM, did not result in less intubation and ventilation in the DR.
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