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Pulmonary Function Testing for Neonatal Respiratory Disorders (PUFFOR Trial)
N/A
Recruiting
Research Sponsored by University of Alabama at Birmingham
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 40 weeks' postmenstrual age or discharge until 2 years
Awards & highlights
PUFFOR Trial Summary
This trial is observing how well different newborns' lungs function. It is measuring how well they respond to treatments given to newborns with lung diseases.
Who is the study for?
This trial is for infants born at or after 22 weeks of gestation who are off ventilators for at least 12 hours. It's open to those whose parents or guardians consent, but not to babies with terminal illnesses, neuromuscular conditions affecting breathing, major malformations, or if there's a decision to limit support.Check my eligibility
What is being tested?
The study observes lung function in newborns using non-invasive forced oscillometry. It aims to understand respiratory health in term and preterm infants with various lung diseases and how they respond to treatments without the need for invasive procedures.See study design
What are the potential side effects?
Since this is an observational study using a non-invasive technique, significant side effects are not expected. The procedure involves measuring breath patterns through gentle airway pressure.
PUFFOR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 40 weeks' postmenstrual age or discharge until 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~40 weeks' postmenstrual age or discharge until 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Area under the reactance curve (AXR)
Secondary outcome measures
Impedance R(f)
Impedance x(f)
Longer-term pulmonary outcomes
+10 morePUFFOR Trial Design
1Treatment groups
Experimental Treatment
Group I: Non-invasive forced airway oscillometryExperimental Treatment1 Intervention
Analyze lung function using forced airway oscillometry in preterm infants and term infants with and without lung disease with both cross-sectional and longitudinal comparisons.
Aim 1: Lung function in term and preterm infants without lung disease (anticipated n=264) Aim 2: Lung function in preterm infants with respiratory distress syndrome (RDS) who develop bronchopulmonary dysplasia (BPD) and preterm infants with RDS who do not develop BPD (anticipated n=264) Aim 3: Lung function measurements in infants with common neonatal lung diseases (including RDS, BPD, meconium aspiration syndrome, and transient tachypnea of the newborn) and controls without lung disease (anticipated n=570) Aim 4: Lung function in infants with lung disease before and after common therapeutic interventions
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Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,590 Previous Clinical Trials
2,280,256 Total Patients Enrolled
Namasivayam Ambalavanan, MDStudy DirectorUniversity of Alabama at Birmingham
6 Previous Clinical Trials
1,372 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My infant has been off a ventilator or CPAP for at least 12 hours.My child's legal guardians have agreed to the study.My infant has a significant birth defect.A decision has been made to limit or not provide further treatment for my infant.My infant has a condition that impacts their breathing.My infant has a life-threatening condition.My baby was born at or after 22 weeks of pregnancy.
Research Study Groups:
This trial has the following groups:- Group 1: Non-invasive forced airway oscillometry
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.
What are the eligibility criteria for participation in this experiment?
"This clinical study is recruiting 1098 infants, aged one day to two years old and suffering from an array of premature-onset pathologies. To be eligible, they must have been born with a gestational age of no less than 22 weeks and their parents/legal guardians are required to provide consent."
Answered by AI
Does this research include participants aged 45 or older?
"The team is seeking infants ranging in age from 1 day to 2 years old for this clinical trial."
Answered by AI
Are there any vacancies within this research project for participants?
"Affirmative. According to clinicaltrials.gov, this trial has been open for recruitment since December 6th of 2017 and was last edited on March 21st 2022. The study is in need of 1098 participants at a single test site."
Answered by AI
What is the current cohort size for this experiment?
"Yes, the online records of clinicaltrials.gov indicate that this medical trial is still recruiting patients. The experiment was first opened up to the public on December 6th 2017 and its details were most recently revised on March 21st 2022. 1098 participants need to be sourced from 1 particular site."
Answered by AI
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