Pulmonary Function Using Non-invasive Forced Oscillometry

NCT03346343 | Active Not Recruiting Results DMC

• 2 other identifiers: IRB-300000296K23HL157618
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this observational study is to measure pulmonary function in term and preterm infants with and without pulmonary disease including respiratory distress syndrome, bronchopulmonary dysplasia, transient tachypnea of the newborn, meconium aspiration syndrome, and response to treatments given to newborn infants with lung diseases using a non-invasive airway oscillometry system.

Conditions

Infant, Premature, Diseases; Infant, Newborn, Diseases; Bronchopulmonary Dysplasia; Respiratory Distress Syndrome, Newborn; Meconium Aspiration Syndrome; Transient Tachypnea of the Newborn

Outcome Measures

Primary Outcomes (1)

• Area Under the Reactance Curve (AXR)

  AXR as the measure of overall measure of reactance of the respiratory system quantified by oscillometry and measured in cmH2O/L

  40 weeks' postmenstrual age or discharge until 2 years

Secondary Outcomes (4)

• R7-20

  40 weeks' postmenstrual age or discharge until 2 years

• R7

  40 weeks' postmenstrual age or discharge until 2 years

• X7

  40 weeks' postmenstrual age or discharge until 2 years

• Longer-term Pulmonary Outcomes

  Up to 2 years

Study Arms (1)

Non-invasive forced airway oscillometry

EXPERIMENTAL

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

Device: Non-invasive forced airway oscillometry

Interventions

Non-invasive forced airway oscillometry DEVICE

This is a non-invasive device will measure lung function in spontaneously breathing infants. Infants will have a cushioned mask placed on his/her face and the device will take measurements as the infant breathes normally.

Non-invasive forced airway oscillometry

Eligibility Criteria

• Age: 1 Day - 2 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Infants with gestational age at least 22 weeks at birth
• Infants off ventilator/continuous positive airway pressure ≥ 12 hours
• Infants whose parents/legal guardians have provided consent

You may not qualify if:

• Infants with major malformation
• Infants with a neuromuscular condition that affects respiration
• Infants with terminal illness
• Infants with a decision made to withhold or limit support

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

Related Publications (1)

• Klinger AP, Travers CP, Martin A, Kuo HC, Alishlash AS, Harris WT, Carlo WA, Ambalavanan N. Non-invasive forced oscillometry to quantify respiratory mechanics in term neonates. Pediatr Res. 2020 Aug;88(2):293-299. doi: 10.1038/s41390-020-0751-7. Epub 2020 Jan 14.

  PMID: 31935746 DERIVED

MeSH Terms

Conditions

Infant, Premature, Diseases; Infant, Newborn, Diseases; Bronchopulmonary Dysplasia; Respiratory Distress Syndrome, Newborn; Meconium Aspiration Syndrome; Transient Tachypnea of the Newborn

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Respiratory Distress Syndrome; Respiration Disorders; Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Tachypnea; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Colm Travers
• Organization: UAB

cptravers@uabmc.edu

2059344680

Study Officials

• Namasivayam Ambalavanan, MD

  University of Alabama at Birmingham

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This will be a single center prospective observational study with pre-specified Aims and Hypotheses

Study Record Dates

• First Submitted: November 10, 2017
• First Posted: November 17, 2017
• Study Start: December 6, 2017
• Primary Completion: October 21, 2024
• Study Completion (Estimated): May 1, 2027
• Last Updated: January 27, 2026
• Results First Posted: January 27, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)