Non-invasive forced airway oscillometry for Neonatal Respiratory Distress Syndrome

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Neonatal Respiratory Distress Syndrome+5 MoreNon-invasive forced airway oscillometry - Device
Eligibility
1 - 2
All Sexes
What conditions do you have?
Select

Study Summary

This trial is observing how well different newborns' lungs function. It is measuring how well they respond to treatments given to newborns with lung diseases.

Eligible Conditions
  • Neonatal Respiratory Distress Syndrome
  • Neonatal Diseases
  • Premature Infant Diseases
  • Bronchopulmonary Dysplasia
  • Transient Tachypnea of the Newborn
  • Meconium Aspiration Syndrome

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 13 Secondary · Reporting Duration: 40 weeks' postmenstrual age or discharge until 2 years

Year 2
Area under the reactance curve (AXR)
Impedance R(f)
Impedance x(f)
R11
R19
R7
R7-20
Resonance frequency
Respiratory rate
Tidal volume
X11
X19
X7
Up to 2 years
Longer-term pulmonary outcomes

Trial Safety

Trial Design

1 Treatment Group

Non-invasive forced airway oscillometry
1 of 1

Experimental Treatment

1098 Total Participants · 1 Treatment Group

Primary Treatment: Non-invasive forced airway oscillometry · No Placebo Group · N/A

Non-invasive forced airway oscillometry
Device
Experimental Group · 1 Intervention: Non-invasive forced airway oscillometry · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 40 weeks' postmenstrual age or discharge until 2 years

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,435 Previous Clinical Trials
2,228,136 Total Patients Enrolled
Namasivayam Ambalavanan, MDStudy DirectorUniversity of Alabama at Birmingham
6 Previous Clinical Trials
1,372 Total Patients Enrolled

Eligibility Criteria

Age 1 - 2 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
, who were born without labour and received care in the neonatal intensive care unit, had a significantly lower rate of death or major morbidity than did infants who were born at less than 22 weeks of gestation
Infants who are no longer ventilated and are receiving continuous positive airway pressure (CPAP) for 12 or more hours can be discharged from the hospital.
to participate in research Infants who are the legal wards of parents or guardians who have provided consent to participate in research are eligible for participation in research studies.