What is the mechanism of action of this treatment?

The most common treatments for Neonatal Respiratory Distress Syndrome (NRDS) include non-invasive respiratory support methods such as Continuous Positive Airway Pressure (CPAP) and High-Flow Nasal Cannula (HFNC). CPAP works by delivering a constant flow of air to maintain positive pressure in the airways, preventing alveolar collapse and improving oxygenation. HFNC provides heated and humidified oxygen at high flow rates, reducing the work of breathing and enhancing gas exchange. These treatments are crucial for NRDS patients as they help stabilize breathing, improve oxygen levels, and reduce the need for invasive mechanical ventilation, thereby minimizing the risk of lung injury and other complications.

What side effects are associated with this type of intervention?

Common treatments for Neonatal Respiratory Distress Syndrome (NRDS) include mechanical ventilation, surfactant therapy, and inhaled nitric oxide. Mechanical ventilation can cause lung injury, such as bronchopulmonary dysplasia and air leaks. Surfactant therapy is generally well-tolerated but may cause transient bradycardia and oxygen desaturation during administration. Inhaled nitric oxide has shown mixed results in preterm infants and may lead to methemoglobinemia and nitrogen dioxide toxicity.

What prior FDA approvals exist?

The FDA has approved several treatments for Neonatal Respiratory Distress Syndrome (RDS), primarily focusing on surfactant replacement therapy, which helps reduce the surface tension in the lungs and improves breathing. Commonly used surfactants include beractant, calfactant, and poractant alfa. These treatments are typically administered via endotracheal tube. While non-invasive airway oscillometry systems are primarily used for measuring pulmonary function and not direct treatment, they can play a crucial role in monitoring the effectiveness of these therapies and the overall respiratory status of infants with RDS.

What other types of research exist?

Promising novel alternatives to non-invasive airway oscillometry for measuring pulmonary function in Neonatal Respiratory Distress Syndrome patients include: 1) Electrical Impedance Tomography (EIT), which provides real-time imaging of lung ventilation and perfusion; 2) Near-Infrared Spectroscopy (NIRS), which measures tissue oxygenation and hemodynamics; and 3) Advanced Ultrasound Techniques, such as lung ultrasound, which can assess lung aeration and fluid content. These methods are non-invasive and have shown potential in improving the diagnosis and management of NRDS.

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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

Must not have

Infants with major malformation

Infants with a decision made to withhold or limit support

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 40 weeks' postmenstrual age or discharge until 2 years

Awards & highlights

No Placebo-Only Group

Summary

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.

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My infant has a significant birth defect.

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A decision has been made to limit or not provide further treatment for my infant.

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My infant has a condition that impacts their breathing.

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My infant has a life-threatening condition.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 40 weeks' postmenstrual age or discharge until 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Area under the reactance curve (AXR)

Secondary study objectives

Impedance R(f)

Impedance x(f)

Longer-term pulmonary outcomes

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Neonatal Respiratory Distress Syndrome (NRDS) include non-invasive respiratory support methods such as Continuous Positive Airway Pressure (CPAP) and High-Flow Nasal Cannula (HFNC). CPAP works by delivering a constant flow of air to maintain positive pressure in the airways, preventing alveolar collapse and improving oxygenation. HFNC provides heated and humidified oxygen at high flow rates, reducing the work of breathing and enhancing gas exchange. These treatments are crucial for NRDS patients as they help stabilize breathing, improve oxygen levels, and reduce the need for invasive mechanical ventilation, thereby minimizing the risk of lung injury and other complications.

Non-invasive respiratory support in preterm infants.Inhaled nitric oxide for respiratory failure in preterm infants.Inhaled nitric oxide therapy in premature newborns.