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Oxygen Saturation Target for Newborn Pulmonary Hypertension (POST-IT Trial)
N/A
Waitlist Available
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Postnatal age ≤ 28 days
Corrected gestational age (postmenstrual age) > 34 6/7 weeks
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 3-7
Awards & highlights
POST-IT Trial Summary
This trial is testing what oxygen saturation levels are best for newborns with pulmonary hypertension. Newborns will be randomly assigned to one of two oxygen saturation goals, and their progress will be monitored.
Who is the study for?
This trial is for newborns up to 28 days old with pulmonary hypertension or related conditions, needing respiratory support and oxygen. They must weigh over 2000g and be born after at least 32 weeks of gestation. Babies with certain heart defects or lethal conditions like trisomy 18 or trisomy 13 cannot participate.Check my eligibility
What is being tested?
The study tests two different goals for blood oxygen levels (95%-99% SpO2) in newborns with pulmonary issues. Participants will be randomly assigned a target range, have their medical records reviewed, and undergo targeted echocardiograms to assess the effects.See study design
What are the potential side effects?
While specific side effects are not listed, monitoring oxygen saturation can affect breathing treatments and may lead to adjustments in respiratory support which could impact the baby's comfort and stability.
POST-IT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My baby is 28 days old or younger.
Select...
My baby is more than 34 weeks and 6 days old, counting from conception.
Select...
My infant has CDH, Down syndrome, HIE, PDA, PFO/ASD, or VSD less than 2 mm.
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I am on a breathing machine or need high oxygen support.
POST-IT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at enrollment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at enrollment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Correlation of the Oxygenation and Echocardiography components of the HRF/PH scores
Hypoxemic Respiratory Failure and Pulmonary Hypertension (HRF/PH) score
Secondary outcome measures
Intracluster correlation coefficients of the HRF/PH score
Preliminary estimates of intervention effects on outcomes (length of stay, duration of mechanical ventilation, and ECMO)
POST-IT Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention armExperimental Treatment1 Intervention
target preductal SpO2 - 95 to 99%
Group II: Standard armActive Control1 Intervention
target preductal SpO2 - 91 to 95%
Find a Location
Who is running the clinical trial?
University of California, DavisLead Sponsor
910 Previous Clinical Trials
4,706,961 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,549 Total Patients Enrolled
National Center for Advancing Translational Sciences (NCATS)NIH
320 Previous Clinical Trials
401,700 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My condition is often fatal in infancy, like trisomy 18 or 13.My baby is 28 days old or younger.My baby is more than 34 weeks and 6 days old, counting from conception.I was born before reaching 32 weeks of pregnancy.I have severe respiratory failure and have been on a ventilator for over an hour despite treatments.My weight is less than 2000 grams at enrollment.I have a heart condition, but it's not ASD/PFO, PDA, or VSD.My infant has CDH, Down syndrome, HIE, PDA, PFO/ASD, or VSD less than 2 mm.An echocardiogram shows signs of pulmonary hypertension.I am on a breathing machine or need high oxygen support.
Research Study Groups:
This trial has the following groups:- Group 1: Standard arm
- Group 2: Intervention arm
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.
Does this medical trial accommodate participants under the age of thirty?
"This trial is seeking infants aged between 0 and 28 days. Furthermore, there are 829 studies targeting individuals over the age of 65 and 86 trials focussing on younger participants."
Answered by AI
Are new participants still being accepted into this experiment?
"This clinical trial, first posted on August 1st 2021 and last updated January 25th 2022, is not currently seeking patients. Nevertheless, there are 936 other medical studies that are actively recruiting participants at this point in time."
Answered by AI
Who is eligible to take part in this research investigation?
"Eligibility to participate requires a diagnosis of pulmonary hypertension, and the age range for participants is 0 days up to 28 days. At present, our team needs 30 patients to join this clinical trial."
Answered by AI
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