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Apneic Oxygenation for Neonatal Respiratory Failure (POINT Trial)
N/A
Recruiting
Led By Elizabeth Foglia, MD, MSCE
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 18 months.
Awards & highlights
POINT Trial 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.
Who is the study for?
This trial is for infants at least 28 weeks corrected gestational age who need a breathing tube inserted in the NICU and have received pre-medication. It's not for babies previously enrolled, with certain health conditions like unstable blood pressure, specific heart or lung problems, COVID-19, or those intubated by non-NICU providers.Check my eligibility
What is being tested?
The study tests if giving oxygen through the nose (apneic oxygenation) to babies who can't breathe on their own during intubation is better than the usual method without extra oxygen. Infants are randomly chosen to receive either apneic oxygenation or standard care at two hospitals.See study design
What are the potential side effects?
While there may be minimal side effects directly from apneic oxygenation itself, potential risks include discomfort from the nasal cannula and possible impact on delicate tissues due to increased airflow.
POINT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 18 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 18 months.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary Clinical Outcome: Change in Oxygen Saturation (SpO2)
Secondary outcome measures
Feasibility Outcome: AO fidelity
Feasibility Outcome: Protocol deviations
Feasibility Outcome: Randomization
+12 moreOther outcome measures
Safety Outcome: Air Leaks
Safety Outcome: Cardiopulmonary resuscitation
Safety Outcome: Duration of time with 100% SpO2
+2 morePOINT Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Apneic OxygenationExperimental Treatment1 Intervention
Group II: Standard of CareActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Apneic Oxygenation
2017
N/A
~200
Find a Location
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,000 Previous Clinical Trials
42,879,978 Total Patients Enrolled
Children's Hospital of PhiladelphiaOTHER
707 Previous Clinical Trials
8,581,181 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,963 Previous Clinical Trials
2,674,631 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a tracheostomy.You cannot reach a level of 90% oxygen in your blood before needing a breathing tube.You have unstable blood pressure or are currently being resuscitated.You have an untreated birth defect called diaphragmatic hernia.You had surgery to fix a hole between your windpipe and esophagus within the past 2 weeks.Inserting a tube through the nose.You are being checked for COVID-19 or have tested positive for it.You have a type of heart disease that causes your skin or lips to turn blue.You are currently using a special type of life support called Extracorporeal Membrane Oxygenation.Twins born physically joined together.Babies who are at least 28 weeks old based on their expected due date.If you needed a breathing tube put in by a doctor who doesn't usually work in the neonatal intensive care unit (NICU).You have taken medication before the study.You have a serious problem with your airway or breathing.Being on a breathing machine in the NICU.
Research Study Groups:
This trial has the following groups:- Group 1: Apneic Oxygenation
- Group 2: Standard of Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are currently registered in this experiment?
"Affirmative, clinicaltrials.gov provides evidence that this medical experiment is actively recruiting volunteers. The listing was first posted on July 21st 2022 and updated recently on August 1st 2022. A total of 110 subjects are needed from a single site for completion of the trial."
Answered by AI
Are there any unfilled openings in this trial that potential participants can access?
"Clinicaltrials.gov attests that this ongoing trial, which commenced on July 21st 2022 and was recently updated on August 1st of the same year, is still recruiting participants."
Answered by AI
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