Mask versus nasal tube for stabilization of preterm infants at birth: A randomized controlled trial

Pediatrics

Volumn 132, Issue 2, 2013, Pages

  Kamlin, C Omar F ^a,b,c   Schilleman, Kim ^d   Dawson, Jennifer A ^a,b,c   Lopriore, Enrico ^d   Donath, Susan M ^c   Schmolzer, Georg M ^a,b,c   Walther, Frans J ^d   Davis, Peter G ^a,b,c   Pas, Arjan B Te ^d  

^a ROYAL WOMEN'S HOSPITAL   (Australia)

^b UNIVERSITY OF MELBOURNE   (Australia)

^c MURDOCH CHILDREN'S RESEARCH INSTITUTE   (Australia)

^d LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

Author keywords

Infant; Nasal ventilation; Neonatal resuscitation; Newborn; Positivepressure ventilation; Prematurity

Indexed keywords

CORTICOSTEROID; SILICONE;

ARTICLE; ASSISTED VENTILATION; AUSTRALIA; BRAIN HEMORRHAGE; COHORT ANALYSIS; CONTROLLED STUDY; DEVICE SAFETY; ENDOTRACHEAL INTUBATION; FACE MASK; FEMALE; GESTATIONAL AGE; HUMAN; INFANT; LUNG DYSPLASIA; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NASAL CANNULA; NECROTIZING ENTEROCOLITIS; NETHERLANDS; NOSE INJURY; POSITIVE END EXPIRATORY PRESSURE; PREMATURITY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RESUSCITATION; RESUSCITATOR;

INFANT; NASAL VENTILATION; NEONATAL RESUSCITATION; NEWBORN; POSITIVE-PRESSURE VENTILATION; PREMATURITY;

AIRWAY OBSTRUCTION; COHORT STUDIES; CONTINUOUS POSITIVE AIRWAY PRESSURE; EARLY TERMINATION OF CLINICAL TRIALS; EQUIPMENT FAILURE ANALYSIS; GESTATIONAL AGE; HUMANS; INFANT, LOW BIRTH WEIGHT; INFANT, NEWBORN; INFANT, VERY LOW BIRTH WEIGHT; INTUBATION, INTRATRACHEAL; MASKS; NETHERLANDS; RESPIRATORY DISTRESS SYNDROME, NEWBORN; RESUSCITATION; VICTORIA;

EID: 84882285992     PISSN: 00314005     EISSN: 10984275     Source Type: Journal    
DOI: 10.1542/peds.2013-0361     Document Type: Article

References (30)

1. Perlman JM, Risser R. Cardiopulmonary resuscitation in the delivery room: associated clinical events. Arch Pediatr Adolesc Med. 1995;149(1):20-25
2. Perlman JM, Wyllie J, Kattwinkel J, et al Neonatal Resuscitation Chapter Collaborators. Part 11: Neonatal resuscitation: 2010 international consensus on cardiopulmonary resuscitation and emergency cardiovascular care science with treatment recommendations. Circulation. 2010;122(16 suppl 2):S516-S538
3. Wyllie J, Perlman JM, Kattwinkel J, et al Neonatal Resuscitation Chapter Collaborators. Part 11: Neonatal resuscitation: 2010 international consensus on cardiopulmonary resuscitation and emergency cardiovascular care science with treatment recommendations. Resuscitation. 2010;81 (suppl 1):e260-e287
4. Kattwinkel J, Perlman JM, Aziz K, et al American Heart Association. Neonatal resuscitation: 2010 American Heart Association guidelines for cardiopulmonary resuscitation and emergency cardiovascular care. Pediatrics. 2010;126(5). Available at: www.pediatrics.org/cgi/content/full/126/5/e1400
5. O'Donnell CP, Davis PG, Lau R, Dargaville PA, Doyle LW, Morley CJ. Neonatal resuscitation 2: an evaluation of manual ventilation devices and face masks. Arch Dis Child Fetal Neonatal Ed. 2005;90(5):F392-F396
6. Wood FE, Morley CJ, Dawson JA, et al. Assessing the effectiveness of two round neonatal resuscitation masks: study 1. Arch Dis Child Fetal Neonatal Ed. 2008;93 (3):F235-F237
7. Wood FE, Morley CJ, Dawson JA, et al. Improved techniques reduce face mask leak during simulated neonatal resuscitation: study 2. Arch Dis Child Fetal Neonatal Ed. 2008;93(3):F230-F234
8. Finer NN, Rich W, Wang C, Leone T. Airway obstruction during mask ventilation of very low birth weight infants during neonatal resuscitation. Pediatrics. 2009;123(3):865-869
9. Schmölzer GM, Dawson JA, Kamlin CO, O'Donnell CP, Morley CJ, Davis PG. Airway obstruction and gas leak during mask ventilation of preterm infants in the delivery room. Arch Dis Child Fetal Neonatal Ed. 2011;96(4):F254-F257
10. Schmölzer GM, Morley CJ, Wong C, et al. Respiratory function monitor guidance of mask ventilation in the delivery room: a feasibility study. J Pediatr. 2012;160(3):377-381
11. Schilleman K, Witlox RS, Lopriore E, Morley CJ, Walther FJ, te Pas AB. Leak and obstruction with mask ventilation during simulated neonatal resuscitation. Arch Dis Child Fetal Neonatal Ed. 2010;95(6):F398-F402
12. O'Donnell CP, Kamlin CO, Davis PG, Morley CJ. Crying and breathing by extremely preterm infants immediately after birth. J Pediatr. 2010;156(5):846-847
13. Morley CJ, Davis PG, Doyle LW, Brion LP, Hascoet JM, Carlin JB; COIN Trial Investigators. Nasal CPAP or intubation at birth for very preterm infants. N Engl J Med. 2008;358(7):700-708
14. Jobe AH, Kramer BW, Moss TJ, Newnham JP, Ikegami M. Decreased indicators of lung injury with continuous positive expiratory pressure in preterm lambs. Pediatr Res. 2002;52(3):387-392
15. Jobe AH, Ikegami M. Mechanisms initiating lung injury in the preterm. Early Hum Dev. 1998;53(1):81-94
16. Lindner W, Vossbeck S, Hummler H, Pohlandt F. Delivery room management of extremely low birth weight infants: spontaneous breathing or intubation? Pediatrics. 1999;103 (5 pt 1):961-967
17. Aly H, Massaro AN, Patel K, El-Mohandes AA. Is it safer to intubate premature infants in the delivery room? Pediatrics. 2005;115(6): 1660-1665
18. Schmolzer GM, Te Pas AB, Davis PG. Morley CJ. Reducing lung injury during neonatal resuscitation of preterm infants. J Pediatr 2008;153(6):741-745
19. Capasso L, Capasso A, Raimondi F, Vendemmia M, Araimo G, Paludetto R. A randomized trial comparing oxygen delivery on intermittent positive pressure with nasal cannulae versus facial mask in neonatal primary resuscitation. Acta Paediatr. 2005;94(2):197-200
20. Lindner W, Högel J, Pohlandt F. Sustained pressure-controlled inflation or intermittent mandatory ventilation in preterm infants in the delivery room? A randomized, controlled trial on initial respiratory support via nasopharyngeal tube. Acta Paediatr. 2005;94 (3):303-309
21. te Pas AB, Walther FJ. A randomized, controlled trial of delivery-room respiratory management in very preterm infants. Pediatrics. 2007;120(2):322-329
22. National Health and Medical Research Council. National Statement on Ethical Conduct in Human Research. Canberra, Australia: Commonwealth of Australia; 2007:23
23. Papile LA, Burstein J, Burstein R, Koffler H. Incidence and evolution of subependymal and intraventricular hemorrhage: a study of infants with birth weights less than 1,500 gm. J Pediatr. 1978;92(4):529-534
24. Jitlal M, Khan I, Lee SM, Hackshaw A. Stopping clinical trials early for futility: retrospective analysis of several randomised clinical studies. Br J Cancer. 2012;107(6):910-917
25. Perlman JM, Wyllie J, Kattwinkel J, et al Neonatal Resuscitation Chapter Collaborators. Neonatal resuscitation: 2010 international consensus on cardiopulmonary resuscitation and emergency cardiovascular care science with treatment recommendations. Pediatrics. 2010;126(5). Available at: www.pediatrics.org/cgi/content/full/126/5/e1319
26. van Vonderen JJ, Kleijn TA, Schilleman K, Walther FJ, Hooper SB, te Pas AB. Compressive force applied to a manikin's head during mask ventilation. Arch Dis Child Fetal Neonatal Ed. 2012;97(4):F254-F258
27. O'Donnell CP, Davis PG, Morley CJ. Positive pressure ventilation at neonatal resuscitation: review of equipment and international survey of practice. Acta Paediatr. 2004;93(5):583-588
28. Schilleman K, van der Pot CJ, Hooper SB, Lopriore E, Walther FJ, Te Pas AB. Evaluating manual inflations and breathing during mask ventilation in preterm infants at birth. J Pediatr. 2013;162(3):457-463
29. te Pas AB, Kamlin CO, Dawson JA, et al. Ventilation and spontaneous breathing at birth of infants with congenital diaphragmatic hernia. J Pediatr. 2009;154(3):369-373
30. Fernandes RM, van der Lee JH, Offringa M. A systematic review of the reporting of data monitoring committees' roles, interim analysis and early termination in pediatric clinical trials. BMC Pediatr. 2009;9:77