Pulmonary Function Testing for Neonatal Respiratory Disorders

(PUFFOR Trial)

Overseen By Colm P Travers, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Major malformation, Neuromuscular condition, Terminal illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand lung function in newborns, both preterm and term, with and without lung problems. Researchers use a gentle, non-invasive method called non-invasive forced airway oscillometry to measure lung function. The study includes infants who are at least 22 weeks gestational age and have been breathing without a ventilator for at least 12 hours. By comparing lung function across different groups, researchers hope to gain insights into conditions like respiratory distress syndrome and other common newborn lung issues. Parents or legal guardians must consent for their infants to participate. As an unphased trial, this study offers a unique opportunity to contribute to important research that could improve care for newborns with lung issues.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that non-invasive forced airway oscillometry is safe for neonatal pulmonary function testing?

Research has shown that non-invasive forced airway oscillometry safely checks lung function in newborns. This method uses gentle airwaves to assess a baby's lung performance. Being non-invasive, it avoids needles or surgery, ensuring comfort for infants.

No reports of harmful side effects have emerged from this technique. It has been successfully applied to both healthy newborns and those with breathing issues, offering valuable information without causing harm. This indicates that non-invasive forced airway oscillometry is well-tolerated and poses minimal risk to infants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using non-invasive forced airway oscillometry for neonatal respiratory disorders because it offers a safer and less invasive way to assess lung function in infants. Unlike traditional methods, which often involve more invasive techniques like intubation or sedation, this approach uses gentle oscillations of air to measure lung function without causing discomfort or harm to the baby. This method allows for both cross-sectional and longitudinal analysis, which can provide a more comprehensive understanding of how lung function develops or deteriorates over time in various neonatal conditions. Ultimately, this technique could lead to better diagnosis and monitoring of respiratory disorders in newborns, potentially improving outcomes for these vulnerable patients.

What evidence suggests that non-invasive forced airway oscillometry is effective for measuring pulmonary function in neonatal respiratory disorders?

Research has shown that non-invasive forced airway oscillometry, studied in this trial, effectively checks lung function in newborns. This technique distinguishes between healthy babies and those with conditions like transient tachypnea of the newborn (TTN) on their first day. Being non-invasive, it avoids needles or surgery, making it ideal for infants. Studies have found that this method provides important information about lung health and can monitor changes over time. This makes it a promising tool for understanding and managing breathing problems in newborns. ^{1 2 5 6 7}

Who Is on the Research Team?

Namasivayam Ambalavanan, MD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

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.

Inclusion 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 baby was born at or after 22 weeks of pregnancy.

Exclusion Criteria

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Observation

Lung function is measured using non-invasive forced oscillometry in term and preterm infants with and without lung disease.

40 weeks' postmenstrual age or until discharge

Follow-up

Participants are monitored for changes in lung function and response to therapeutic interventions.

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Non-invasive forced airway oscillometry

Trial Overview 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.

How Is the Trial Designed?

Group I: Non-invasive forced airway oscillometry Experimental Treatment 1 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

Non-invasive forced airway oscillometry is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Non-invasive forced oscillometry for:

• Assessment of lung function in infants and adults
• Diagnosis of respiratory diseases such as asthma and COPD

Approved in United States as Forced oscillation technique for:

• Assessment of lung function in infants and adults
• Monitoring of respiratory mechanics during mechanical ventilation and sleep

Approved in Canada as Impulse oscillometry for:

• Assessment of lung function in preterm infants
• Diagnosis of respiratory diseases such as bronchopulmonary dysplasia

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Published Research Related to This Trial

Pulmonary function testing is crucial for diagnosing and managing respiratory insufficiency in critically ill neonates, allowing for better prognosis and tailored therapy.

Recent advancements in technology enable quick and accurate bedside assessments of neonatal pulmonary function, emphasizing the important role of intensive care nurses in obtaining reliable data to inform care plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary function testing in the critically ill neonate, Part I: An overview. Greenspan, JS., Cullen, JA., Zukowsky, K., et al.[2004]

Pulmonary function testing in neonates is a crucial, low-risk diagnostic tool that helps monitor lung disease progression and assess responses to treatments like surfactant therapy, and it can be performed at the bedside in under 60 minutes.

These tests provide immediate results that can guide nursing care, measuring important pulmonary 'vital signs' such as tidal volume and respiratory rate, and can be conducted on infants regardless of their ventilation status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary function testing in the critically ill neonate, Part II: Methodology. Cullen, JA., Greenspan, JS., Antunes, MJ., et al.[2004]

Respiratory oscillometry is a valuable pulmonary function test that can be performed with minimal patient cooperation, making it suitable for young children and those unable to perform traditional spirometry due to cognitive or physical limitations.

After implementing a formal training program and standard operating protocol for respiratory oscillometry, there was a significant improvement in the quality of tests, leading to more acceptable and reproducible measurements, which is crucial for accurate lung function assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conducting Respiratory Oscillometry in an Outpatient Setting. Chang, E., Vasileva, A., Nohra, C., et al.[2023]

Impulse oscillometry is a useful technique for assessing asthma control in children aged 5-15 years, especially for those who cannot perform spirometry, as it is less dependent on patient effort.

Both impulse oscillometry and spirometry provide comparable information for monitoring asthma control, with specific parameters like FEV1 and area of reactance (AX) showing significant associations with controlled asthma over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of Impulse Oscillometry in Assessing Asthma Control in Children. Dawman, L., Mukherjee, A., Sethi, T., et al.[2020]

In a study involving 39 healthy volunteers, three different mouthpieces for impulse oscillometry were compared, revealing significant differences in lung resistance and reactance measurements, particularly between the oval mouthpiece and the circular mouthpiece with a free-flow piece.

The circular mouthpiece coupled with a free-flow piece (B3) was found to be the most effective and preferred option, providing lower impedance values and greater comfort for subjects during the tests.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Influence of Different Mouthpieces on Impulse Oscillometry Results. Dionísio, GH., Dos Santos, DO., Perossi, L., et al.[2018]

The automated pulmonary function testing system (PEDS) allows for rapid and non-invasive assessment of lung mechanics and energetics in neonates, providing valuable data on compliance, resistance, and respiratory drive.

This testing method enhances the understanding of respiratory dysfunction in critically ill neonates and aids in optimizing mechanical ventilation and pharmacological treatments, despite some limitations in evaluating very sick patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Diagnosis of lung function in intensive care of newborn infants]. Reiterer, F., Kuttnig-Haim, M., Müller, W.[2006]

In a study involving 64 patients with interstitial lung disease (ILD) and other respiratory conditions, forced oscillometry revealed that ILD patients had increased respiratory resistance and decreased reactance compared to healthy controls, indicating distinct lung function characteristics.

The study found that changes in reactance (ΔX5) during breathing were significantly different in ILD patients compared to those with asthma and COPD, suggesting that ΔX5 could be a potential marker for assessing the severity of ILD and its physiological abnormalities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics of inspiratory and expiratory reactance in interstitial lung disease. Sugiyama, A., Hattori, N., Haruta, Y., et al.[2013]

Impulse oscillometry (IOS) effectively distinguishes between asthmatic and non-asthmatic children, showing a significant bronchodilator response that correctly identified 77% of asthma cases in a study of 117 children.

IOS is a non-invasive method that can be used alongside or as an alternative to spirometry for assessing lung function in children, as it provides objective measurements of lung impedance without the variability seen in spirometry.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A study of the use of impulse oscillometry in the evaluation of children with asthma: analysis of lung parameters, order effect, and utility compared with spirometry. Komarow, HD., Skinner, J., Young, M., et al.[2022]

Impulse oscillometry (IOS) is a quick and minimally invasive method for assessing pulmonary function in horses, showing repeatable results in both healthy and diseased animals, making it a viable alternative to traditional pulmonary function tests.

In horses with clinical signs of heaves, specific IOS measurements (increased respiratory resistance and negative reactance values) can effectively indicate respiratory distress, highlighting its potential for routine clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measurement of respiratory function by impulse oscillometry in horses. van Erck, E., Votion, D., Art, T., et al.[2019]

The forced oscillation technique (FOT) is a non-invasive and easy-to-use method for measuring lung function in preschool children, with 87% of children aged 4 years and older successfully performing the test compared to only 21% success in simple spirometry.

FOT demonstrated a significant agreement with spirometry in measuring the response to bronchodilator therapy, indicating its reliability as a lung function assessment tool for young children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of the forced oscillation technique to detect bronchodilation in children: experience from the Schneider Children's Medical Center of Israel. Bar-Yishay, E., Matyashchuk, E., Mussaffi, H., et al.[2013]

Impulse oscillometry (IOS) is a promising non-invasive method for assessing lung function in children with cystic fibrosis (CF), showing significant differences in resistance and reactance compared to healthy controls.

During acute exacerbations, IOS measurements indicated increased resistance and decreased reactance, which returned to baseline levels after treatment, suggesting that IOS can effectively monitor lung function changes in CF patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of children with cystic fibrosis by impulse oscillometry when stable and at exacerbation. Sakarya, A., Uyan, ZS., Baydemir, C., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7358118/

Non-invasive Forced Oscillometry to Quantify Respiratory ... FOT is feasible in neonates and distinguishes normal control infants from those with TTN on postnatal day 1. Oscillometry offers a non-invasive, longitudinal ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31935746/

Non-invasive forced oscillometry to quantify respiratory ... Oscillometry offers a non-invasive, longitudinal technique to assess lung mechanics in newborns ... To determine normative data by forced oscillation technique ( ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT03346343/pulmonary-function-using-non-invasive-forced-oscillometry

Pulmonary Function Using Non-invasive Forced Oscillometry The purpose of this observational study is to measure pulmonary function in term and preterm infants with and without pulmonary disease ...

4. clinicaltrial.be clinicaltrial.be/en/details/58027?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

Forced Oscillometry in Infants with Bronchopulmonary Dysp... The forced oscillation technique (FOT) is a non-invasive method that had been used to measure respiratory mechanics. FOT employs small amplitude ...

5. mdpi.com mdpi.com/2227-9067/10/11/1753

Noninvasive Monitoring Strategies for Bronchopulmonary ... The interruption technique, forced oscillation technique, and pulse oscillometry for the study of resistances and reactances could be implemented. Other serial ...

6. frontiersin.org frontiersin.org/journals/pediatrics/articles/10.3389/fped.2022.867883/full

Respiratory Oscillometry in Newborn Infants: Conventional ... Respiratory oscillometry measures the mechanical impedance of the respiratory system (Zrs), and it has been shown as a promising method in different ...

7. publications.ersnet.org publications.ersnet.org/content/erj/22/6/1026

The forced oscillation technique in clinical practice The forced oscillation technique (FOT) is a noninvasive method with which to measure respiratory mechanics. FOT employs small-amplitude pressure oscillations ...