Non-inflatable Supraglottic Airway (NI-SGA) vs. Face Mask (FM) as a Primary Interface Device for Neonatal Resuscitation
NCT ID: NCT02629887
Last Updated: 2018-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2018-04-15
2018-04-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Face Mask
Standard Face Mask with T piece resuscitator for neonatal resuscitation. Face mask placement per Neonatal Resuscitation Program resuscitation guideline.
Face Mask
at delivery - standard airway management per Neonatal Resuscitation Program utilizing face mask.
T-Piece Resuscitator
T-Piece Resuscitator for providing postivie pressure ventilation via face mask or non-inflatable supraglottic airway
Non-inflatable supraglottic airway
Use of non-inflating supraglottic airway with T-piece resuscitator instead of Standard Face Mask with T piece resuscitator for neonatal resuscitation, replacing standard of care face mask in Neonatal Resuscitation Program guideline.
Non-inflatable supraglottic airway
at delivery if resuscitation is required infant randomized to NI-SGA or face mask as the interface for positive pressure ventilation.
T-Piece Resuscitator
T-Piece Resuscitator for providing postivie pressure ventilation via face mask or non-inflatable supraglottic airway
Interventions
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Non-inflatable supraglottic airway
at delivery if resuscitation is required infant randomized to NI-SGA or face mask as the interface for positive pressure ventilation.
Face Mask
at delivery - standard airway management per Neonatal Resuscitation Program utilizing face mask.
T-Piece Resuscitator
T-Piece Resuscitator for providing postivie pressure ventilation via face mask or non-inflatable supraglottic airway
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Known congenital malformations
* Multiple gestation (twins and above)
* History of meconium stained fluid
30 Minutes
ALL
No
Sponsors
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University of Oklahoma
OTHER
Responsible Party
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Principal Investigators
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Arlen Foulks, DO
Role: PRINCIPAL_INVESTIGATOR
University of Oklahoma
Locations
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University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Countries
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References
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Liu L, Oza S, Hogan D, Perin J, Rudan I, Lawn JE, Cousens S, Mathers C, Black RE. Global, regional, and national causes of child mortality in 2000-13, with projections to inform post-2015 priorities: an updated systematic analysis. Lancet. 2015 Jan 31;385(9966):430-40. doi: 10.1016/S0140-6736(14)61698-6. Epub 2014 Sep 30.
Ersdal HL, Singhal N. Resuscitation in resource-limited settings. Semin Fetal Neonatal Med. 2013 Dec;18(6):373-8. doi: 10.1016/j.siny.2013.07.001. Epub 2013 Jul 27.
Wyckoff MH, Perlman JM. Effective ventilation and temperature control are vital to outborn resuscitation. Prehosp Emerg Care. 2004 Apr-Jun;8(2):191-5. doi: 10.1016/j.prehos.2003.12.013.
Wyckoff MH, Perlman JM, Laptook AR. Use of volume expansion during delivery room resuscitation in near-term and term infants. Pediatrics. 2005 Apr;115(4):950-5. doi: 10.1542/peds.2004-0913.
Ersdal HL, Mduma E, Svensen E, Perlman JM. Early initiation of basic resuscitation interventions including face mask ventilation may reduce birth asphyxia related mortality in low-income countries: a prospective descriptive observational study. Resuscitation. 2012 Jul;83(7):869-73. doi: 10.1016/j.resuscitation.2011.12.011. Epub 2011 Dec 23.
Szyld E, Aguilar A, Musante GA, Vain N, Prudent L, Fabres J, Carlo WA; Delivery Room Ventilation Devices Trial Group. Comparison of devices for newborn ventilation in the delivery room. J Pediatr. 2014 Aug;165(2):234-239.e3. doi: 10.1016/j.jpeds.2014.02.035. Epub 2014 Mar 29.
Kattwinkel J, Perlman JM, Aziz K, Colby C, Fairchild K, Gallagher J, Hazinski MF, Halamek LP, Kumar P, Little G, McGowan JE, Nightengale B, Ramirez MM, Ringer S, Simon WM, Weiner GM, Wyckoff M, Zaichkin J; American Heart Association. Neonatal resuscitation: 2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Pediatrics. 2010 Nov;126(5):e1400-13. doi: 10.1542/peds.2010-2972E. Epub 2010 Oct 18. No abstract available.
O'Donnell CP, Davis PG, Morley CJ. Positive pressure ventilation at neonatal resuscitation: review of equipment and international survey of practice. Acta Paediatr. 2004 May;93(5):583-8. doi: 10.1111/j.1651-2227.2004.tb02981.x.
Hartung JC, te Pas AB, Fischer H, Schmalisch G, Roehr CC. Leak during manual neonatal ventilation and its effect on the delivered pressures and volumes: an in vitro study. Neonatology. 2012;102(3):190-5. doi: 10.1159/000339325. Epub 2012 Jul 10.
Deindl P, O'Reilly M, Zoller K, Berger A, Pollak A, Schwindt J, Schmolzer GM. Influence of mask type and mask position on the effectiveness of bag-mask ventilation in a neonatal manikin. Eur J Pediatr. 2014 Jan;173(1):75-9. doi: 10.1007/s00431-013-2122-4. Epub 2013 Aug 11.
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 Mar;162(3):457-63. doi: 10.1016/j.jpeds.2012.09.036. Epub 2012 Oct 25.
Schmolzer GM, Kamlin OC, O'Donnell CP, Dawson JA, Morley CJ, Davis PG. Assessment of tidal volume and gas leak during mask ventilation of preterm infants in the delivery room. Arch Dis Child Fetal Neonatal Ed. 2010 Nov;95(6):F393-7. doi: 10.1136/adc.2009.174003. Epub 2010 Jun 14.
Foglia EE, Owen LS, Thio M, Ratcliffe SJ, Lista G, Te Pas A, Hummler H, Nadkarni V, Ades A, Posencheg M, Keszler M, Davis P, Kirpalani H. Sustained Aeration of Infant Lungs (SAIL) trial: study protocol for a randomized controlled trial. Trials. 2015 Mar 15;16:95. doi: 10.1186/s13063-015-0601-9.
Kattwinkel J, Perlman JM, Aziz K, Colby C, Fairchild K, Gallagher J, Hazinski MF, Halamek LP, Kumar P, Little G, McGowan JE, Nightengale B, Ramirez MM, Ringer S, Simon WM, Weiner GM, Wyckoff M, Zaichkin J. Part 15: neonatal resuscitation: 2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2010 Nov 2;122(18 Suppl 3):S909-19. doi: 10.1161/CIRCULATIONAHA.110.971119. No abstract available.
Richmond S, Wyllie J. European Resuscitation Council Guidelines for Resuscitation 2010 Section 7. Resuscitation of babies at birth. Resuscitation. 2010 Oct;81(10):1389-99. doi: 10.1016/j.resuscitation.2010.08.018. No abstract available.
Schmolzer GM, Agarwal M, Kamlin CO, Davis PG. Supraglottic airway devices during neonatal resuscitation: an historical perspective, systematic review and meta-analysis of available clinical trials. Resuscitation. 2013 Jun;84(6):722-30. doi: 10.1016/j.resuscitation.2012.11.002. Epub 2012 Nov 9.
Leone TA, Rich W, Finer NN. A survey of delivery room resuscitation practices in the United States. Pediatrics. 2006 Feb;117(2):e164-75. doi: 10.1542/peds.2005-0936.
Schreiner MS, Feltman D, Wiswell T, Wootton S, Arnold C, Tyson J, Lantos JD. When is waiver of consent appropriate in a neonatal clinical trial? Pediatrics. 2014 Nov;134(5):1006-12. doi: 10.1542/peds.2014-0207. Epub 2014 Oct 6.
Nichol G, Huszti E. Design and implementation of resuscitation research: special challenges and potential solutions. Resuscitation. 2007 Jun;73(3):337-46. doi: 10.1016/j.resuscitation.2006.10.021. Epub 2007 Feb 9.
Paterson SJ, Byrne PJ, Molesky MG, Seal RF, Finucane BT. Neonatal resuscitation using the laryngeal mask airway. Anesthesiology. 1994 Jun;80(6):1248-53; discussion 27A.
Gandini D, Brimacombe JR. Neonatal resuscitation with the laryngeal mask airway in normal and low birth weight infants. Anesth Analg. 1999 Sep;89(3):642-3. doi: 10.1097/00000539-199909000-00018. No abstract available.
Zanardo V, Weiner G, Micaglio M, Doglioni N, Buzzacchero R, Trevisanuto D. Delivery room resuscitation of near-term infants: role of the laryngeal mask airway. Resuscitation. 2010 Mar;81(3):327-30. doi: 10.1016/j.resuscitation.2009.11.005. Epub 2009 Dec 22.
Zhu XY, Lin BC, Zhang QS, Ye HM, Yu RJ. A prospective evaluation of the efficacy of the laryngeal mask airway during neonatal resuscitation. Resuscitation. 2011 Nov;82(11):1405-9. doi: 10.1016/j.resuscitation.2011.06.010. Epub 2011 Jul 16.
Trevisanuto D, Cavallin F, Nguyen LN, Nguyen TV, Tran LD, Tran CD, Doglioni N, Micaglio M, Moccia L. Supreme Laryngeal Mask Airway versus Face Mask during Neonatal Resuscitation: A Randomized Controlled Trial. J Pediatr. 2015 Aug;167(2):286-91.e1. doi: 10.1016/j.jpeds.2015.04.051. Epub 2015 May 21.
Bernhard M, Benger JR. Airway management during cardiopulmonary resuscitation. Curr Opin Crit Care. 2015 Jun;21(3):183-7. doi: 10.1097/MCC.0000000000000201.
Other Identifiers
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5848
Identifier Type: -
Identifier Source: org_study_id
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