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

1098 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Non-invasive forced airway oscillometry for neonatal respiratory disorders?

Research shows that techniques like impulse oscillometry, which are part of the treatment, are effective in measuring lung function in children with conditions like asthma and cystic fibrosis. These methods are non-invasive, require minimal cooperation, and are sensitive in detecting changes in small airways, making them suitable for young children and potentially effective for neonatal respiratory disorders. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Non-invasive forced airway oscillometry, Non-invasive forced oscillometry, Forced oscillation technique, Impulse oscillometry, Respiratory oscillometry for neonatal respiratory disorders?

Research shows that techniques like impulse oscillometry and forced oscillation are effective in measuring lung function in children, especially when they cannot perform traditional tests. These methods are non-invasive and require minimal cooperation, making them suitable for young children and potentially effective for neonatal respiratory disorders. ^{1 2 3 4 5}

Is pulmonary function testing using oscillometry safe for humans?

Pulmonary function testing using oscillometry, which includes techniques like forced oscillation and impulse oscillometry, is generally considered safe for humans. It is non-invasive, requires minimal patient cooperation, and is suitable for young children and those unable to perform traditional lung function tests. ^{1 2 4 6 7}

Is pulmonary function testing using oscillometry safe for humans?

Pulmonary function testing using oscillometry is generally considered safe for humans, including young children and those unable to perform traditional lung tests. It is non-invasive, requires minimal cooperation, and has minimal contraindications, making it suitable for a wide range of patients. ^{1 2 4 6 7}

How is non-invasive forced airway oscillometry different from other treatments for neonatal respiratory disorders?

Non-invasive forced airway oscillometry is unique because it requires minimal patient cooperation and is more sensitive in detecting changes in small airways compared to traditional pulmonary function tests. This makes it particularly useful for infants who cannot perform standard tests due to their age or condition. ^{1 8 9 10 11}

How does non-invasive forced airway oscillometry differ from other treatments for neonatal respiratory disorders?

Non-invasive forced airway oscillometry is unique because it requires minimal patient cooperation and is more sensitive in detecting changes in small airways compared to traditional pulmonary function tests. This makes it particularly useful for young children and patients who cannot perform standard tests due to cognitive or physical limitations. ^{1 8 9 10 11}

What is the purpose of this trial?

This trial uses a new device to measure lung function in newborns by sending gentle airwaves into their lungs while they breathe normally. It targets term and preterm infants, especially those with lung diseases, because traditional methods are difficult and often require sedation. This method is easier and safer for measuring lung function in newborns.

Research Team

Namasivayam Ambalavanan, MD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Conducting Respiratory Oscillometry in an Outpatient Setting. [2023]

2. India pubmed.ncbi.nlm.nih.gov

Role of Impulse Oscillometry in Assessing Asthma Control in Children. [2020]

3. United States 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. [2022]

4. Israel 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. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

Evaluation of children with cystic fibrosis by impulse oscillometry when stable and at exacerbation. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

The Influence of Different Mouthpieces on Impulse Oscillometry Results. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Characteristics of inspiratory and expiratory reactance in interstitial lung disease. [2013]

8. United States pubmed.ncbi.nlm.nih.gov

Pulmonary function testing in the critically ill neonate, Part I: An overview. [2004]

9. United States pubmed.ncbi.nlm.nih.gov

Pulmonary function testing in the critically ill neonate, Part II: Methodology. [2004]

10. Austria pubmed.ncbi.nlm.nih.gov

[Diagnosis of lung function in intensive care of newborn infants]. [2006]

11. United States pubmed.ncbi.nlm.nih.gov

Measurement of respiratory function by impulse oscillometry in horses. [2019]