Non-inflatable Supraglottic Airway (NI-SGA) vs. Face Mask (FM) as a Primary Interface Device for Neonatal Resuscitation

NCT02629887 | Withdrawn DMC FDA Device

• 1 other identifier: 5848
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective, randomized controlled trial to be performed at one center, of term and late preterm infants requiring resuscitation. Prenatal consent will be obtained. At randomization, babies will be resuscitated following Neonatal Resuscitation Program (NRP) guidelines and ventilated using the T-piece resuscitator with either a Face Mask (FM) or Non-inflating supraglottic airway. Video will be collected during resuscitation as well as written documentation. Primary outcome will be time to spontaneous breathing, length of resuscitation, and need for endotracheal intubation.

Conditions

Neonatal Resuscitation

Keywords

supraglottic airway; neonatal resuscitation; ventilation; term infant

Outcome Measures

Primary Outcomes (3)

• Time to Spontaneous Breathing

  Record of time from beginning of resuscitation to time of spontaneous breathing

  30 minutes

• Duration of Positive Pressure Ventilation

  Total time of positive pressure ventilation required to adequate spontaneous breathing.

  30 minutes

• Need for subsequent endotracheal intubation

  Failure of non-invasive resuscitative efforts by face mask or NI-SGA requiring intubation per NRP guideline.

  30 minutes

Secondary Outcomes (7)

• Time needed for NI-SGA placement

  1 minute

• Need for drugs in resuscitation

  30 minutes

• Use of Chest Compressions

  30 minutes

• Use of oxygen

  30 minutes

• Rate of complications associated with resuscitation

  30 minutes

Study Arms (2)

Face Mask

ACTIVE COMPARATOR

Standard Face Mask with T piece resuscitator for neonatal resuscitation. Face mask placement per Neonatal Resuscitation Program resuscitation guideline.

Device: Face Mask; Device: T-Piece Resuscitator

Non-inflatable supraglottic airway

ACTIVE COMPARATOR

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.

Device: Non-inflatable supraglottic airway; Device: T-Piece Resuscitator

Interventions

Non-inflatable supraglottic airway DEVICE

at delivery if resuscitation is required infant randomized to NI-SGA or face mask as the interface for positive pressure ventilation.

Non-inflatable supraglottic airway

Face Mask DEVICE

at delivery - standard airway management per Neonatal Resuscitation Program utilizing face mask.

Face Mask

T-Piece Resuscitator DEVICE

T-Piece Resuscitator for providing postivie pressure ventilation via face mask or non-inflatable supraglottic airway

Face Mask; Non-inflatable supraglottic airway

Eligibility Criteria

• Age: Up to 30 Minutes
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Newborns \> or = 2000gms requiring positive pressure ventilation within the first 2 minutes of life

You may not qualify if:

• Newborns with expected fetal weight \<2000 grams
• Known congenital malformations
• Multiple gestation (twins and above)
• History of meconium stained fluid

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73117, United States

Location

Related Publications (25)

• 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.

  PMID: 25280870 BACKGROUND

• 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.

  PMID: 23896083 BACKGROUND

• 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.

  PMID: 15060855 BACKGROUND

• 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.

  PMID: 15805369 BACKGROUND

• 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.

  PMID: 22198423 BACKGROUND

• 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.

  PMID: 24690329 BACKGROUND

• 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.

  PMID: 20956432 BACKGROUND

• 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.

  PMID: 15174776 BACKGROUND

• 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.

  PMID: 22796898 BACKGROUND

• 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.

  PMID: 23933670 BACKGROUND

• 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.

  PMID: 23102793 BACKGROUND

• 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.

  PMID: 20547584 BACKGROUND

• 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.

  PMID: 25872563 BACKGROUND

• 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.

  PMID: 20956231 BACKGROUND

• 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.

  PMID: 20956046 BACKGROUND

• 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.

  PMID: 23146881 BACKGROUND

• 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.

  PMID: 16452326 BACKGROUND

• 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.

  PMID: 25287456 BACKGROUND

• 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.

  PMID: 17292525 BACKGROUND

• 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.

  PMID: 8010471 BACKGROUND

• 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.

  PMID: 10475295 BACKGROUND

• 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.

  PMID: 20022416 BACKGROUND

• 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.

  PMID: 21763393 BACKGROUND

• 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.

  PMID: 26003882 BACKGROUND

• Bernhard M, Benger JR. Airway management during cardiopulmonary resuscitation. Curr Opin Crit Care. 2015 Jun;21(3):183-7. doi: 10.1097/MCC.0000000000000201.

  PMID: 25922892 BACKGROUND

MeSH Terms

Conditions

Respiratory Aspiration

Interventions

Masks

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Attire; Equipment and Supplies, Hospital; Equipment and Supplies; Protective Devices; Personal Protective Equipment; Surgical Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Arlen Foulks, DO

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2015
• First Posted: December 14, 2015
• Study Start: April 15, 2018
• Primary Completion: April 15, 2018
• Study Completion: April 15, 2018
• Last Updated: May 9, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)