Study Summary
This trial will compare apneic oxygenation to standard care in order to determine if apneic oxygenation reduces oxygen desaturation during tracheal intubation in infants in the NICU.
Eligible Conditions
- Tracheal Intubation Morbidity
- Neonatal Respiratory Failure
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 15 Secondary · Reporting Duration: Through study completion, an average of 18 months.
During Intubation Procedure
Safety Outcome: Duration of time with 100% SpO2
Intubation, Intratracheal
During intubation procedure
Feasibility Outcome: Protocol deviations
Primary Clinical Outcome: Change in Oxygen Saturation (SpO2)
Secondary Clinical Outcome: Change in pulse rate
Secondary Clinical Outcome: Duration of intubation attempts
Intubation (procedure)
Secondary Clinical Outcome: Severe oxygen desaturation
Saturation of Peripheral Oxygen
Secondary Clinical Outcome: Time to SpO2 <80%
Intubation (procedure)
Hour 1
Safety Outcome: Cardiopulmonary resuscitation
During the intubation procedure
Feasibility Outcome: AO fidelity
Three hours after intubation
Secondary Clinical Outcome: PaO2
Secondary Clinical Outcome: pCO2
Secondary Clinical Outcome: pH
Month 18
Feasibility Outcome: Randomization
Feasibility Outcome: Recruitment
Feasibility Outcome: Screening
Hour 24
Safety Outcome: Air Leaks
Safety Outcome: Nasal Trauma
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Standard of Care
1 of 2
Apneic Oxygenation
1 of 2
Active Control
Experimental Treatment
110 Total Participants · 2 Treatment Groups
Primary Treatment: Apneic Oxygenation · No Placebo Group · N/A
Apneic Oxygenation
Procedure
Experimental Group · 1 Intervention: Apneic Oxygenation · Intervention Types: ProcedureStandard of Care
Procedure
ActiveComparator Group · 1 Intervention: Standard of Care · Intervention Types: ProcedureTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Apneic Oxygenation
2017
N/A
~200
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 18 months.
Who is running the clinical trial?
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,821 Previous Clinical Trials
2,238,026 Total Patients Enrolled
University of PennsylvaniaLead Sponsor
1,840 Previous Clinical Trials
41,126,267 Total Patients Enrolled
Children's Hospital of PhiladelphiaOTHER
648 Previous Clinical Trials
7,849,328 Total Patients Enrolled
Elizabeth Foglia, MD, MSCEPrincipal InvestigatorUniversity of Pennsylvania
Eligibility Criteria
Age Any Age · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are ≥28 weeks gestation.
References
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- Roberts, Calum T., Louise S. Owen, Brett J. Manley, Dag H. Frøisland, Susan M. Donath, Kim M. Dalziel, Margo A. Pritchard, et al.. 2016. “Nasal High-flow Therapy for Primary Respiratory Support in Preterm Infants”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1603694.
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- “Cummings JJ, Polin RA, COMMITTEE ON FETUS AND NEWBORN. Oxygen Targeting in Extremely Low Birth Weight Infants. pediatrics. 2016;138(2):e20161576”. 2016. “Cummings JJ, Polin RA, COMMITTEE ON FETUS AND NEWBORN. Oxygen Targeting in Extremely Low Birth Weight Infants. pediatrics. 2016;138(2):e20161576”. Pediatrics. American Academy of Pediatrics (AAP). doi:10.1542/peds.2016-2904.
- Dempsey, E M. 2006. “Facilitation of Neonatal Endotracheal Intubation with Mivacurium and Fentanyl in the Neonatal Intensive Care Unit”. Archives of Disease in Childhood - Fetal and Neonatal Edition. BMJ. doi:10.1136/adc.2005.087213.
- Venkatesh, Vidheya, Vennila Ponnusamy, Juliet Anandaraj, Rajiv Chaudhary, Manish Malviya, Paul Clarke, Anusha Arasu, and Anna Curley. 2010. “Endotracheal Intubation in a Neonatal Population Remains Associated with a High Risk of Adverse Events”. European Journal of Pediatrics. Springer Science and Business Media LLC. doi:10.1007/s00431-010-1290-8.
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- Gupta, Samir, and Steven M. Donn. 2016. “Continuous Positive Airway Pressure: Physiology and Comparison of Devices”. Seminars in Fetal and Neonatal Medicine. Elsevier BV. doi:10.1016/j.siny.2016.02.009.
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- Lee, Jan Hau, for the Pediatric Acute Lung Injury and Sepsis Investigators (PALISI), David A. Turner, Pradip Kamat, Sholeen Nett, Justine Shults, Vinay M. Nadkarni, Akira Nishisaki, and the National Emergency Airway Registry for Children (NEAR4KIDS). 2016. “The Number of Tracheal Intubation Attempts Matters! A Prospective Multi-institutional Pediatric Observational Study”. BMC Pediatrics. Springer Science and Business Media LLC. doi:10.1186/s12887-016-0593-y.
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- Grude, Ola, Helene Jørgensen Solli, Claus Andersen, and Nils Petter Oveland. 2018. “Effect of Nasal or Nasopharyngeal Apneic Oxygenation on Desaturation During Induction of Anesthesia and Endotracheal Intubation in the Operating Room: A Narrative Review of Randomized Controlled Trials”. Journal of Clinical Anesthesia. Elsevier BV. doi:10.1016/j.jclinane.2018.07.002.
- Brown CA 3rd, Bair AE, Pallin DJ, Walls RM; NEAR III Investigators. Techniques, success, and adverse events of emergency department adult intubations. Ann Emerg Med. 2015 Apr;65(4):363-370.e1. doi: 10.1016/j.annemergmed.2014.10.036. Epub 2014 Dec 20. Erratum In: Ann Emerg Med. 2017 May;69(5):540.
- Durrmeyer X, Breinig S, Claris O, Tourneux P, Alexandre C, Saliba E, Beuchee A, Jung C, Levy C, Marchand-Martin L, Marcoux MO, Dechartres A, Danan C; PRETTINEO Research Group. Effect of Atropine With Propofol vs Atropine With Atracurium and Sufentanil on Oxygen Desaturation in Neonates Requiring Nonemergency Intubation: A Randomized Clinical Trial. JAMA. 2018 May 1;319(17):1790-1801. doi: 10.1001/jama.2018.3708.
- Windpassinger M, Plattner O, Gemeiner J, Roder G, Baumann A, Zimmerman NM, Sessler DI. Pharyngeal Oxygen Insufflation During AirTraq Laryngoscopy Slows Arterial Desaturation in Infants and Small Children. Anesth Analg. 2016 Apr;122(4):1153-7. doi: 10.1213/ANE.0000000000001189.
- Kumar P, Denson SE, Mancuso TJ; Committee on Fetus and Newborn, Section on Anesthesiology and Pain Medicine. Premedication for nonemergency endotracheal intubation in the neonate. Pediatrics. 2010 Mar;125(3):608-15. doi: 10.1542/peds.2009-2863. Epub 2010 Feb 22.
- Foglia EE, Ades A, Sawyer T, Glass KM, Singh N, Jung P, Quek BH, Johnston LC, Barry J, Zenge J, Moussa A, Kim JH, DeMeo SD, Napolitano N, Nadkarni V, Nishisaki A; NEAR4NEOS Investigators. Neonatal Intubation Practice and Outcomes: An International Registry Study. Pediatrics. 2019 Jan;143(1):e20180902. doi: 10.1542/peds.2018-0902. Epub 2018 Dec 11.
- Dempsey EM, Al Hazzani F, Faucher D, Barrington KJ. Facilitation of neonatal endotracheal intubation with mivacurium and fentanyl in the neonatal intensive care unit. Arch Dis Child Fetal Neonatal Ed. 2006 Jul;91(4):F279-82. doi: 10.1136/adc.2005.087213. Epub 2006 Feb 7.
- Roberts KD, Leone TA, Edwards WH, Rich WD, Finer NN. Premedication for nonemergent neonatal intubations: a randomized, controlled trial comparing atropine and fentanyl to atropine, fentanyl, and mivacurium. Pediatrics. 2006 Oct;118(4):1583-91. doi: 10.1542/peds.2006-0590.
- Gupta S, Donn SM. Continuous positive airway pressure: Physiology and comparison of devices. Semin Fetal Neonatal Med. 2016 Jun;21(3):204-11. doi: 10.1016/j.siny.2016.02.009. Epub 2016 Mar 3.
- Patel R, Lenczyk M, Hannallah RS, McGill WA. Age and the onset of desaturation in apnoeic children. Can J Anaesth. 1994 Sep;41(9):771-4. doi: 10.1007/BF03011582.
- Cummings JJ, Polin RA, COMMITTEE ON FETUS AND NEWBORN. Oxygen Targeting in Extremely Low Birth Weight Infants. Pediatrics. 2016;138(2):e20161576. Pediatrics. 2016 Dec;138(6):e20162904. doi: 10.1542/peds.2016-2904. No abstract available.
- Oliveira J E Silva L, Cabrera D, Barrionuevo P, Johnson RL, Erwin PJ, Murad MH, Bellolio MF. Effectiveness of Apneic Oxygenation During Intubation: A Systematic Review and Meta-Analysis. Ann Emerg Med. 2017 Oct;70(4):483-494.e11. doi: 10.1016/j.annemergmed.2017.05.001. Epub 2017 Jul 14.
- Neumann RP, von Ungern-Sternberg BS. The neonatal lung--physiology and ventilation. Paediatr Anaesth. 2014 Jan;24(1):10-21. doi: 10.1111/pan.12280. Epub 2013 Oct 24.
- Wilkinson DJ, Andersen CC, Smith K, Holberton J. Pharyngeal pressure with high-flow nasal cannulae in premature infants. J Perinatol. 2008 Jan;28(1):42-7. doi: 10.1038/sj.jp.7211879. Epub 2007 Nov 8.
- Di Fiore JM, Poets CF, Gauda E, Martin RJ, MacFarlane P. Cardiorespiratory events in preterm infants: interventions and consequences. J Perinatol. 2016 Apr;36(4):251-8. doi: 10.1038/jp.2015.165. Epub 2015 Nov 19.
- Grude O, Solli HJ, Andersen C, Oveland NP. Effect of nasal or nasopharyngeal apneic oxygenation on desaturation during induction of anesthesia and endotracheal intubation in the operating room: A narrative review of randomized controlled trials. J Clin Anesth. 2018 Dec;51:1-7. doi: 10.1016/j.jclinane.2018.07.002. Epub 2018 Jul 18.
- Roberts CT, Owen LS, Manley BJ, Froisland DH, Donath SM, Dalziel KM, Pritchard MA, Cartwright DW, Collins CL, Malhotra A, Davis PG; HIPSTER Trial Investigators. Nasal High-Flow Therapy for Primary Respiratory Support in Preterm Infants. N Engl J Med. 2016 Sep 22;375(12):1142-51. doi: 10.1056/NEJMoa1603694.
- Elizabeth Foglia 2022. "Providing Oxygen During Intubation in the NICU Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05451953.
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