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Neonatal Respiratory FailurePOINTNCT05451953

Providing Oxygen During Intubation in the NICU Trial

A study testing Apneic Oxygenation in people with Neonatal Respiratory Failure and Tracheal Intubation Morbidity, run by University of Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Tracheal intubation in the NICU is frequently complicated by severe oxygen desaturation. Apneic oxygenation, a method of applying free flowing oxygen via nasal cannula to apneic patients undergoing intubation, prevents or delays oxygen desaturation during intubation in adults and older children. Read more about this study

Who is it for?
Ages 0 to 365 days
What is being tested?
Apneic Oxygenation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
1 siteUnited States
Study dates
20 Jul 2022to 3 Jun 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 to 365 days
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Infants ≥28 weeks corrected gestational age
  • Undergoing intubation in the NICU
  • Pre-medication (including paralytic) administered

Who cannot join

  • Critical Airway or Airway Anomaly
  • Unstable hemodynamics (i.e. active resuscitation)
  • Unable to achieve SpO2 ≥90% prior to intubation attempt
  • Intubation performed by Non-NICU provider (i.e. anesthesiology or ENT)
  • Unrepaired congenital diagrammatic hernia
  • Tracheal esophageal fistula within 2 weeks of repair
Show all 13Show fewer
  • Tracheostomy
  • Previous enrollment in the trial
  • Nasal intubation
  • COVID person under investigation (PUI) or COVID positive
  • Cyanotic heart disease
  • Receiving Extracorporeal Membrane Oxygenation support
  • Conjoined twins

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Apneic Oxygenation to Prevent Oxygen Desaturation During Intubation in the NICU

Tracheal intubation in the NICU is frequently complicated by severe oxygen desaturation. Apneic oxygenation, a method of applying free flowing oxygen via nasal cannula to apneic patients undergoing intubation, prevents or delays oxygen desaturation during intubation in adults and older children. We propose to enroll patients at two sites (Hospital of the University of Pennsylvania and Children's Hospital of Philadelphia) in a randomized trial in infants undergoing intubation in the NICU to determine if apneic oxygenation, compared with no respiratory support or oxygen during laryngoscopy and intubation attempts (standard care), reduces the magnitude of oxygen desaturation during tracheal intubation encounters.

Being tested
Apneic Oxygenation, Standard of Care
Keywords
Apneic Oxygenation, Tracheal Intubation, Neonate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Apneic OxygenationProcedure or surgery

    Nasal cannula at a rate of 6L/min with 100% FiO2 during laryngoscopy and intubation attempt(s)

  • Standard of CareProcedure or surgery

    No respiratory support during laryngoscopy and intubation attempt(s) (current standard of care)

Study groups in NCT05451953
Study groupRoleWhat they receive
Apneic OxygenationExperimentalNot described
Receives: Procedure: Apneic Oxygenation
Standard of CareActive comparatorNot described
Receives: Procedure: Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Clinical Outcome: Change in Oxygen Saturation (SpO2)

    Difference between highest SpO2 immediately prior to first intubation attempt and lowest SpO2 during the intubation encounter.

    Measured: During intubation procedure

Secondary outcomes (15)

  1. Secondary Clinical Outcome: Severe oxygen desaturation

    ≥20% decline in SpO2

    Measured: During intubation procedure

  2. Secondary Clinical Outcome: SpO2<80%

    SpO2<80% at any point

    Measured: During intubation procedure

  3. Secondary Clinical Outcome: Time to SpO2 <80%

    Time to SpO2 <80% from facemask removal

    Measured: During intubation procedure

  4. Secondary Clinical Outcome: intubation success

    First intubation attempt success

    Measured: During intubation procedure

  5. Secondary Clinical Outcome: Number of intubation attempts

    Total number of intubation attempts

    Measured: During intubation procedure

  6. Secondary Clinical Outcome: Duration of intubation attempts

    Duration of each intubation attempt

    Measured: During intubation procedure

  7. Secondary Clinical Outcome: Change in pulse rate

    Difference between highest and lowest pulse rate

    Measured: During intubation procedure

  8. Secondary Clinical Outcome: pH

    First blood gas pH

    Measured: Three hours after intubation

  9. Secondary Clinical Outcome: pCO2

    First blood gas pCO2

    Measured: Three hours after intubation

  10. Secondary Clinical Outcome: PaO2

    First blood gas PaO2 (for infants with indwelling arterial lines)

    Measured: Three hours after intubation

  11. Feasibility Outcome: AO fidelity

    Proportion subjects allocated to AO successfully provided the AO intervention

    Measured: During the intubation procedure

  12. Feasibility Outcome: Protocol deviations

    Number of protocol deviations and violations

    Measured: During intubation procedure

  13. Feasibility Outcome: Screening

    Proportion of intubated infants successfully screened in advance

    Measured: Through study completion, an average of 18 months.

  14. Feasibility Outcome: Recruitment

    Rates of informed consent

    Measured: Through study completion, an average of 18 months.

  15. Feasibility Outcome: Randomization

    Proportion of consented infants who were randomized

    Measured: Through study completion, an average of 18 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2022
  2. Study start20 Jul 2022
  3. Primary completion2 Jun 2026
  4. Study completion3 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel group open-label randomized controlled trial.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05451953
Sponsor's protocol ID
19-017190
Other IDs
R21HD103927
Acronym
POINT
Status last verified
Jun 2026
First submitted
7 Jun 2022
Last updated
11 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The PI will make data available after study completion and in accordance with NIH policies. Our data will only be provided to those investigators who agree to adhere to a signed research data use agreement. The execution of the agreement will require approval by the institution's IRB or demonstration of IRB exemption per institutional policy. The data and the associated documentation will be available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and does not identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.

Publications

  • 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.

    PubMed 26583943

  • Di Fiore JM, Bloom JN, Orge F, Schutt A, Schluchter M, Cheruvu VK, Walsh M, Finer N, Martin RJ. A higher incidence of intermittent hypoxemic episodes is associated with severe retinopathy of prematurity. J Pediatr. 2010 Jul;157(1):69-73. doi: 10.1016/j.jpeds.2010.01.046. Epub 2010 Mar 20.

    PubMed 20304417

  • 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.

    PubMed 30538147

  • Poets CF, Roberts RS, Schmidt B, Whyte RK, Asztalos EV, Bader D, Bairam A, Moddemann D, Peliowski A, Rabi Y, Solimano A, Nelson H; Canadian Oxygen Trial Investigators. Association Between Intermittent Hypoxemia or Bradycardia and Late Death or Disability in Extremely Preterm Infants. JAMA. 2015 Aug 11;314(6):595-603. doi: 10.1001/jama.2015.8841.

    PubMed 26262797

  • 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.

    PubMed 20176672

  • 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.

    PubMed 30029021

  • Steiner JW, Sessler DI, Makarova N, Mascha EJ, Olomu PN, Zhong JW, Setiawan CT, Handy AE, Kravitz BN, Szmuk P. Use of deep laryngeal oxygen insufflation during laryngoscopy in children: a randomized clinical trial. Br J Anaesth. 2016 Sep;117(3):350-7. doi: 10.1093/bja/aew186. Epub 2016 Jul 27.

    PubMed 27466252

  • 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.

    PubMed 26991620

  • Humphreys S, Lee-Archer P, Reyne G, Long D, Williams T, Schibler A. Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) in children: a randomized controlled trial. Br J Anaesth. 2017 Feb;118(2):232-238. doi: 10.1093/bja/aew401.

    PubMed 28100527

  • Napolitano N, Laverriere EK, Craig N, Snyder M, Thompson A, Davis D, Nett S, Branca A, Harwayne-Gidansky I, Sanders R Jr, Shults J, Nadkarni V, Nishisaki A; National Emergency Airway Registry for Children (NEAR4KIDS) and Pediatric Acute Lung Injury and Sepsis Investigators (PALISI). Apneic Oxygenation As a Quality Improvement Intervention in an Academic PICU. Pediatr Crit Care Med. 2019 Dec;20(12):e531-e537. doi: 10.1097/PCC.0000000000002123.

    PubMed 31568243

  • Long E, Cincotta DR, Grindlay J, Sabato S, Fauteux-Lamarre E, Beckerman D, Carroll T, Quinn N. A quality improvement initiative to increase the safety of pediatric emergency airway management. Paediatr Anaesth. 2017 Dec;27(12):1271-1277. doi: 10.1111/pan.13275. Epub 2017 Oct 24.

    PubMed 29063722

  • Vukovic AA, Hanson HR, Murphy SL, Mercurio D, Sheedy CA, Arnold DH. Apneic oxygenation reduces hypoxemia during endotracheal intubation in the pediatric emergency department. Am J Emerg Med. 2019 Jan;37(1):27-32. doi: 10.1016/j.ajem.2018.04.039. Epub 2018 Apr 18.

    PubMed 29699900

  • Nishisaki A, Turner DA, Brown CA 3rd, Walls RM, Nadkarni VM; National Emergency Airway Registry for Children (NEAR4KIDS); Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network. A National Emergency Airway Registry for children: landscape of tracheal intubation in 15 PICUs. Crit Care Med. 2013 Mar;41(3):874-85. doi: 10.1097/CCM.0b013e3182746736.

    PubMed 23328260

  • Li S, Hsieh TC, Rehder KJ, Nett S, Kamat P, Napolitano N, Turner DA, Adu-Darko M, Jarvis JD, Krawiec C, Derbyshire AT, Meyer K, Giuliano JS Jr, Tala J, Tarquinio K, Ruppe MD, Sanders RC Jr, Pinto M, Howell JD, Parker MM, Nuthall G, Shepherd M, Emeriaud G, Nagai Y, Saito O, Lee JH, Simon DW, Orioles A, Walson K, Vanderford P, Shenoi A, Lee A, Bird GL, Miksa M, Graciano AL, Bain J, Skippen PW, Polikoff LA, Nadkarni V, Nishisaki A; for National Emergency Airway Registry for Children (NEAR4KIDS) and Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network. Frequency of Desaturation and Association With Hemodynamic Adverse Events During Tracheal Intubations in PICUs. Pediatr Crit Care Med. 2018 Jan;19(1):e41-e50. doi: 10.1097/PCC.0000000000001384.

    PubMed 29210925

  • 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.

    PubMed 25533140

Questions about this trial

What is this clinical trial studying?

A study testing Apneic Oxygenation in people with Neonatal Respiratory Failure and Tracheal Intubation Morbidity, run by University of Pennsylvania at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Clinical Outcome: Change in Oxygen Saturation (SpO2) (time frame: During intubation procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05451953, which also lists 36 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.

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