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Kamlin, CO; Schilleman, K; Dawson, JA; Lopriore, E; Donath, SM; Schmölzer, GM; Walther, FJ; Davis, PG; Te Pas, AB.
Mask versus nasal tube for stabilization of preterm infants at birth: a randomized controlled trial.
Pediatrics. 2013; 132(2):e381-e388
Doi: 10.1542/peds.2013-0361
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PubMed
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- Co-authors Med Uni Graz
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Schmölzer Georg
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- Abstract:
- OBJECTIVE: Positive-pressure ventilation (PPV) using a manual ventilation device and a face mask is recommended for compromised newborn infants in the delivery room (DR). Mask ventilation is associated with airway obstruction and leak. A nasal tube is an alternative interface, but its safety and efficacy have not been tested in extremely preterm infants. METHODS: An unblinded randomized controlled trial was conducted in Australia, and the Netherlands. Infants were stratified by gestational age (24-25/26-29 weeks) and center. Immediately before birth infants were randomly assigned to receive PPV and/or continuous positive airway pressure with either a nasal tube or a size 00 soft, round silicone mask. Resuscitation protocols were standardized; respiratory support was provided using a T-piece device commencing in room air. Criteria for intubation included need for cardiac compressions, apnea, continuous positive airway pressure >7 cm H2O, and fraction of inspired oxygen >0.4. Primary outcome was endotracheal intubation in the first 24 hours from birth. RESULTS: Three hundred sixty-three infants were randomly assigned; the study terminated early on the grounds of futility. Baseline variables were similar between groups. Intubation rates in the first 24 hours were 54% and 55% in the nasal tube and face mask groups, respectively (odds ratio: 0.97; 95% confidence interval: 0.63-1.50). There were no important differences in any of the secondary outcomes within the whole cohort or between the 2 gestational age subgroups. CONCLUSIONS: In infants at <30 weeks' gestation receiving PPV in the DR, there were no differences in short-term outcomes using the nasal tube compared with the face mask.
- Find related publications in this database (using NLM MeSH Indexing)
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Airway Obstruction - etiology
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Cohort Studies -
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Continuous Positive Airway Pressure - instrumentation
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Early Termination of Clinical Trials -
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Equipment Failure Analysis -
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Gestational Age -
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Humans -
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Infant, Low Birth Weight -
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Infant, Newborn -
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Infant, Very Low Birth Weight -
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Intubation, Intratracheal -
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Masks -
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Masks -
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Respiratory Distress Syndrome, Newborn - therapy
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Resuscitation -
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Resuscitation -
- Find related publications in this database (Keywords)
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infant
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newborn
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neonatal resuscitation
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prematurity
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positive-pressure ventilation
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nasal ventilation