CLINICAL TRIAL

Continuous positive airway pressure for Anoxia

Recruiting · Any Age · All Sexes · Birmingham, AL

This study is evaluating whether CPAP is better than NC for preterm infants.

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About the trial for Anoxia

Eligible Conditions
Respiratory Distress Syndrome · Newborn, Infant, Disease · Bronchopulmonary Dysplasia · Infant, Newborn, Diseases · Respiratory Distress Syndrome, Newborn · Hypoxia

Treatment Groups

This trial involves 2 different treatments. Continuous Positive Airway Pressure is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Continuous positive airway pressure
PROCEDURE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Nasal Cannula
PROCEDURE

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Continuous positive airway pressure
2013
Completed Phase 4
~1590

Side Effect Profile for Sham CPAP

Sham CPAP
Show all side effects
Broken arm
4%
Hit by falling snow
4%
Vasovagal reaction
4%
Coronary artery bypass surgery
4%
Asthenia
4%
Vomiting
4%
Persistent bleeding at skin biopsy site
4%
Skin cancer
0%
Spinal cancer
0%
Hematoma
0%
IV infiltration
0%
This histogram enumerates side effects from a completed 2017 Phase 2 trial (NCT01629862) in the Sham CPAP ARM group. Side effects include: Broken arm with 4%, Hit by falling snow with 4%, Vasovagal reaction with 4%, Coronary artery bypass surgery with 4%, Asthenia with 4%.

Eligibility

This trial is for patients born any sex of any age. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
to be randomized Infants who are currently using CPAP (without a rate) and have a PEEP ≤ 5 and FiO2 ≤ 30% will be randomized. show original
postoperative If a patient has been previously Intubated, they must be extubated at least 72 hours postoperative. show original
There were three self-resolving apneas and/or bradycardia episodes in the last six hours. show original
If the baby is born before 34 weeks, the baby's gestational age is less than 34 weeks. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 24 hours of intervention
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 24 hours of intervention.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Continuous positive airway pressure will improve 1 primary outcome and 10 secondary outcomes in patients with Anoxia. Measurement will happen over the course of 24 hours of intervention.

The median cNIRS value
24 HOURS OF INTERVENTION
Median cerebral near-infrared spectroscopy value during the 24 hour intervention period
The number of episodes (≥ 10 seconds) with oxygen saturations less than 80 %
24 HOURS OF INTERVENTION
The median supplemental oxygen concentration
24 HOURS OF INTERVENTION
The proportion of time spent outside oxygen saturation target ranges (91-95%) among infants requiring supplemental oxygen
24 HOURS OF INTERVENTION
The proportion of time with oxygen saturations > 95 % among infants requiring supplemental oxygen
24 HOURS OF INTERVENTION
The coefficient of variability of oxygen saturations (relative standard deviation)
24 HOURS OF INTERVENTION
The coefficient of variation is a standardized measure of dispersion of a frequency distribution defined as the ratio of the standard deviation to the mean. It will be used in this study to assess the stability of oxygen saturations.
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Who is running the study

Principal Investigator
S. Y.
Siamak Yazdi, Principal Investigator, Neonatology Fellow
University of Alabama at Birmingham

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get anoxia a year in the United States?

The frequency of anoxia in the United States is not sufficiently known. The highest rates are seen in the elderly population, among rural white men and the most economically disadvantaged people in the United States. The highest rates of anoxia are seen only in the states of Washington and Western Texas.

Anonymous Patient Answer

What is anoxia?

There is significant overlap between anoxic and ischemic brain injury in the acute setting, particularly in the setting of cerebral oedema and diffusely reversible ischaemic axonal damage. Patients suffering from both of these types of injury may have a significantly worse prognosis.

Anonymous Patient Answer

What are common treatments for anoxia?

Inadequate oxygen has various serious consequences in the human body. A variety of treatments are available to alleviate anoxia, including the use of oxygen, hyperbaric chambers, and resuscitation.

Anonymous Patient Answer

What causes anoxia?

The exact cause of anoxic episodes is unknown. Many theories to explain this phenomenon have been proposed, including ischemic mechanisms, hypoxia, cardiac insufficiency by other means, or delayed cerebral ischemia that may occur during surgery or during cardiac arrest. If a precise cause is not established, the name Sudden Death Syndrome should be used when reporting possible explanations for anoxia.

Anonymous Patient Answer

What are the signs of anoxia?

Symptoms of anoxia can be mistaken for other conditions, especially seizure-inducing conditions. This can lead to a severe lack of oxygen in the brain (hypoxia).\n

Anonymous Patient Answer

Can anoxia be cured?

The main causes of anoxia-induced retinopathy in patients who survive a severe intracranial aneurysm hemorrhage are irreversible hypoxia and retinal edema. Treatment results in an excellent visual outcome in almost two thirds of cases.

Anonymous Patient Answer

Have there been any new discoveries for treating anoxia?

Currently, there is no way to tell whether an individual is going to suffer hypoxic toxicity or anoxia if given chemotherapy, radiation therapy, or surgery. New research is being conducted in order to identify markers that will identify who is at risk for this deadly disease. Once such markers have been discovered, the goal will be to prevent these patients from suffering from the most debilitating effects of these treatments before the patient is even diagnosed.

Anonymous Patient Answer

What are the latest developments in continuous positive airway pressure for therapeutic use?

Improvements in the design and mechanics of the CPAP may result in a significant increase in the pressure delivered to patients with mild to moderate OSA. This translates into a marked reduction in the time required for the CPAP prescription to be completed and an improvement in adherence to the treatment regimen.

Anonymous Patient Answer

What does continuous positive airway pressure usually treat?

The treatment of sleep apnea is not necessarily determined by severity but can be modified by patient age and sleep duration. CPAP therapy can improve sleepiness, but it is not a reliable cure. Power may help you find CPAP trials tailored to your condition and symptoms.

Anonymous Patient Answer

Who should consider clinical trials for anoxia?

Subjects with SIDS are a vulnerable population who have been shown to have significant problems in the future as they would have no possibility of preventive care. This is in line with the NICE recommendations, which would exclude SIDS subjects from being part of any potential clinical trials for anoxia. The reasons for this decision appear understandable as the main aim of the NICE guidelines being to prevent a sudden SIDS event was not in line with the aim of eliminating the chances of harm to such a vulnerable population, and NICE’s guidelines do not exclude individuals without SIDS from clinical trials for anoxia. Further research could be undertaken to determine other criteria which could exclude individuals with SIDS from clinical trials for anoxia.

Anonymous Patient Answer

What are the common side effects of continuous positive airway pressure?

Continuous positive airway pressure can be delivered as effectively as previously studied with non-CPAP protocols. The most common side effects are dry mucosal irritation or sore throat during the early stage of treatment. At the conclusion of the treatment or if the symptoms are present, the treatment should be tapered off slowly to the lowest pressure needed to keep the patient awake, well oxygenated and well hydrated. A small percentage can develop a severe reaction after the first few weeks of treatment. This can be treated with an antipruritic and cold spray. In a few instances, this can be life-threatening and a high degree of awareness and early intervention is needed.

Anonymous Patient Answer

How does continuous positive airway pressure work?

CPAP reduced AECPO2 in all three patient groups, and also reduced the need for tracheal intubation. In addition to reducing the need for intubation, CPAP also appeared to improve long-term prognosis in the acute stages of severe ARDS associated with ALI/ARDS.

Anonymous Patient Answer
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