Pulmonary Function Testing for Neonatal Respiratory Disorders
(PUFFOR Trial)
Recruiting in Palo Alto (17 mi)
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: University of Alabama at Birmingham
Disqualifiers: Major malformation, Neuromuscular condition, Terminal illness, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
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.
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.
12345Is 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.
12467How 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.
1891011Eligibility 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.
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Participant Groups
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.
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
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Alabama at BirminghamBirmingham, AL
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Who Is Running the Clinical Trial?
University of Alabama at BirminghamLead Sponsor
References
Conducting Respiratory Oscillometry in an Outpatient Setting. [2023]Respiratory oscillometry is a different modality of pulmonary function testing that is increasingly used in a clinical and research setting to provide information regarding lung mechanics. Respiratory oscillometry is conducted through three acceptable measurements of tidal breathing and can be performed with minimal contraindications. Young children and patients who cannot perform spirometry due to cognitive or physical impairment can usually complete oscillometry. The main advantages of respiratory oscillometry are that it requires minimal patient cooperation and is more sensitive in detecting changes in small airways than conventional pulmonary function tests. Commercial devices are now available. Updated technical guidelines, standard operating protocols, and quality control/assurance guidelines have recently been published. Reference values are also available. We conducted oscillometry test audits before and after implementing a formal respiratory oscillometry training program and standard operating protocol. We observed improvement in the quality of tests completed, with a significant increase in the number of acceptable and reproducible measurements. The current paper outlines and demonstrates a standard operating protocol to conduct respiratory oscillometry in an outpatient setting. We highlight the key steps to ensuring acceptable and reproducible quality measurements according to the recommended European Respiratory Society (ERS) guidelines, as quality control is critical to measurement accuracies. Potential problems and pitfalls are also discussed with suggestions to resolve technical errors.
Role of Impulse Oscillometry in Assessing Asthma Control in Children. [2020]Impulse oscillometry is an effort-independent technique of assessment of airway resistance and reactance, and can be performed in children unable to complete spirometry.
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]The ability to objectively measure lung function in children is critical in the assessment and treatment of asthma in this age group. We thus determined the effectiveness of impulse oscillometry (IOS) as a non-invasive technique to assess lung function in children and in comparison to spirometry for sensitivity and specificity, testing variability, and the order effect of sequential testing of IOS and spirometry.
Use of the forced oscillation technique to detect bronchodilation in children: experience from the Schneider Children's Medical Center of Israel. [2013]The forced oscillation technique is a noninvasive and effort-independent technique that is well suited for lung function measurement in young children. FOT employs small-amplitude pressure oscillations superimposed on normal breathing. Therefore, it has the advantage over conventional lung function techniques in that it does not require patient cooperation for conducting respiratory maneuvers.
Evaluation of children with cystic fibrosis by impulse oscillometry when stable and at exacerbation. [2018]Pulmonary function tests are important in the diagnosis and follow-up of airway disease in cystic fibrosis (CF). Conventional spirometry for which repeated forced expiration maneuver are needed is considered as the main method. Impulse oscillometry (IOS) is a non-invasive method, which needs minimal cooperation. We performed a prospective cross-sectional study to determine the pulmonary function in CF children with IOS, and evaluate the IOS measurements during acute exacerbation. We hypothesized that IOS can detect lung function impairment in CF patients and detect changes during acute exacerbations.
The Influence of Different Mouthpieces on Impulse Oscillometry Results. [2018]Impulse oscillometry is a method of airway assessment and diagnosis that provides data on lung mechanics. In the literature, studies have used different types of mouthpieces or did not describe the model used for the tests. We sought to compare the 3 most commonly described mouthpieces in terms of test results, comfort, and subject preference.
Characteristics of inspiratory and expiratory reactance in interstitial lung disease. [2013]Forced oscillometry is a non-invasive method to measure respiratory resistance and reactance. In this study, we investigated the characteristics of measurements obtained with an impulse oscillation system (IOS) for patients with interstitial lung disease (ILD).
Pulmonary function testing in the critically ill neonate, Part I: An overview. [2004]Respiratory insufficiency, a frequent problem encountered by the critically ill neonate, has many etiologies. Pulmonary function testing can effectively diagnose, quantify, and qualify the dysfunction so as to better define a prognosis and guide appropriate therapy. Recent advances in computer-assisted technology and miniaturization of equipment now allow simple, reproducible, and rapid neonatal pulmonary function assessment at the bedside. The indications for, and benefits of, pulmonary function testing vary with gestation, age, and clinical condition of the infant. The overall description of the pulmonary function profile is discussed in this article. The general questions and approaches utilized for routine testing, the initial pulmonary function profile, and evaluation of the acutely ill infant and that of the convalescing preterm are addressed. The expertise of the intensive care nurse is invaluable in ensuring that safe, accurate, and reproducible data are obtained. The nurse can then use the data to alter the infant's care plan and to determine the necessity and timing for retesting. Specific information on methodology and examples of specific tests are given in related articles (Parts II, Vol. 13 No. 2 and III, Vol. 13 No. 4, respectively). A complete knowledge of pulmonary function assessment is important for any nurse caring for critically ill neonates.
Pulmonary function testing in the critically ill neonate, Part II: Methodology. [2004]Pulmonary function testing is an important diagnostic tool in neonatal intensive care. These tests provide a detailed assessment of an infant's pulmonary status that can be used in several ways: to monitor the progression of lung disease, to streamline ventilator management, and to assess the infant's response to new treatments, such as surfactant replacement therapy or bronchodilators. In some settings, these tests are performed by specially trained nurses, and the results are available immediately for planning nursing care. This relatively noninvasive and low-risk assessment can be performed on all infants, whether on mechanical ventilation or breathing spontaneously. A comprehensive pulmonary function evaluation can be performed at the bedside in less than 60 minutes and is generally well tolerated. In this article, the determination of pulmonary "vital signs" tidal volume, minute ventilation, respiratory rate, pulmonary compliance, resistance, resistive work of breathing, and functional residual capacity-are discussed. The esophageal balloon technique for measuring dynamic pulmonary mechanics and energetics, as well as the helium dilution technique for measuring functional residual capacity, are described.
[Diagnosis of lung function in intensive care of newborn infants]. [2006]We report our initial experience with pulmonary function testing in neonates during intensive care, using an automated, computerized system (PEDS), which allows non-invasive and rapid determination of pulmonary mechanics and energetics such as compliance, resistance and respiratory drive, and measurement of lung volume (functional residual capacity). This method is used for better physiological characterization and quantification of the respiratory status, to assess the effectiveness of mechanical ventilation and pharmacological therapy, and to guide weaning and extubation. Despite certain limitations with regard to direct evaluation of the respiratory status especially in very sick neonates, pulmonary function testing has contributed to a better understanding of the pathophysiological mechanisms of pulmonary dysfunction and can also be useful to optimize clinical management of neonates in intensive care.
Measurement of respiratory function by impulse oscillometry in horses. [2019]Due to technical implementations and lack of sensitivity, pulmonary function tests are seldom used in clinical practice. Impulse oscillometry (IOS) could represent an alternative method.