Providing Oxygen During Intubation in the NICU Trial (POINT)

June 9, 2026 updated by: Elizabeth Foglia, University of Pennsylvania

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 1 year (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard of Care
Procedure: Standard of Care
No respiratory support during laryngoscopy and intubation attempt(s) (current standard of care)
Experimental: Apneic Oxygenation
Procedure: Apneic Oxygenation
Nasal cannula at a rate of 6L/min with 100% FiO2 during laryngoscopy and intubation attempt(s)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Clinical Outcome: Change in Oxygen Saturation (SpO2)
Time Frame: During intubation procedure
Difference between highest SpO2 immediately prior to first intubation attempt and lowest SpO2 during the intubation encounter.
During intubation procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary Clinical Outcome: Severe oxygen desaturation
Time Frame: During intubation procedure
≥20% decline in SpO2
During intubation procedure
Secondary Clinical Outcome: SpO2<80%
Time Frame: During intubation procedure
SpO2<80% at any point
During intubation procedure
Secondary Clinical Outcome: Time to SpO2 <80%
Time Frame: During intubation procedure
Time to SpO2 <80% from facemask removal
During intubation procedure
Secondary Clinical Outcome: intubation success
Time Frame: During intubation procedure
First intubation attempt success
During intubation procedure
Secondary Clinical Outcome: Number of intubation attempts
Time Frame: During intubation procedure
Total number of intubation attempts
During intubation procedure
Secondary Clinical Outcome: Duration of intubation attempts
Time Frame: During intubation procedure
Duration of each intubation attempt
During intubation procedure
Secondary Clinical Outcome: Change in pulse rate
Time Frame: During intubation procedure
Difference between highest and lowest pulse rate
During intubation procedure
Secondary Clinical Outcome: pH
Time Frame: Three hours after intubation
First blood gas pH
Three hours after intubation
Secondary Clinical Outcome: pCO2
Time Frame: Three hours after intubation
First blood gas pCO2
Three hours after intubation
Secondary Clinical Outcome: PaO2
Time Frame: Three hours after intubation
First blood gas PaO2 (for infants with indwelling arterial lines)
Three hours after intubation
Feasibility Outcome: AO fidelity
Time Frame: During the intubation procedure
Proportion subjects allocated to AO successfully provided the AO intervention
During the intubation procedure
Feasibility Outcome: Protocol deviations
Time Frame: During intubation procedure
Number of protocol deviations and violations
During intubation procedure
Feasibility Outcome: Screening
Time Frame: Through study completion, an average of 18 months.
Proportion of intubated infants successfully screened in advance
Through study completion, an average of 18 months.
Feasibility Outcome: Recruitment
Time Frame: Through study completion, an average of 18 months.
Rates of informed consent
Through study completion, an average of 18 months.
Feasibility Outcome: Randomization
Time Frame: Through study completion, an average of 18 months.
Proportion of consented infants who were randomized
Through study completion, an average of 18 months.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety Outcome: Cardiopulmonary resuscitation
Time Frame: During or within 1 hour of procedure
Chest compressions with or without epinephrine
During or within 1 hour of procedure
Safety Outcome: Air Leaks
Time Frame: Within 24 hours of procedure
New pneumothorax
Within 24 hours of procedure
Safety Outcome: Nasal Trauma
Time Frame: Within 24 hours of procedure
New nasal trauma
Within 24 hours of procedure
Safety Outcome: adverse Tracheal Intubation Adverse Events
Time Frame: During Intubation Procedure
Tracheal Intubation Adverse Events, per NEAR4NEOS definitions
During Intubation Procedure
Safety Outcome: Duration of time with 100% SpO2
Time Frame: During Intubation Procedure
Duration of time with SpO2=100%
During Intubation Procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Children's Hospital of Philadelphia

Investigators

  • Principal Investigator: Elizabeth Foglia, MD, MSCE, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2022

Primary Completion (Actual)

June 2, 2026

Study Completion (Actual)

June 3, 2026

Study Registration Dates

First Submitted

June 7, 2022

First Submitted That Met QC Criteria

July 6, 2022

First Posted (Actual)

July 11, 2022

Study Record Updates

Last Update Posted (Actual)

June 11, 2026

Last Update Submitted That Met QC Criteria

June 9, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-017190
  • R21HD103927 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

After study completion.

IPD Sharing Access Criteria

Data use agreement in place prior to data sharing.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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