Lung Ultrasound - Prospective Study

The Utility of Lung Ultrasound Scores to Determine Extubation Readiness in Neonates With Respiratory Distress on Mechanical Ventilation

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06140615

Enrollment

Registered

2023-11-20

Start date

2023-12-11

Completion date

2026-02-01

Last updated

2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Distress of Newborn

Brief summary

The goal of this clinical trial is to determine whether lung ultrasound can predict extubation success in neonates with respiratory distress. Participants will undergo a lung ultrasound pre- and post-extubation.

Interventions

DEVICEUltrasound

Ultrasound of lungs

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 6 Months

Healthy volunteers

Inclusion criteria

* Infants born at UnityPoint Health Meriter Hospital and University of Minnesota admitted to the Neonatal Intensive Care Unit (NICU) with respiratory distress requiring intubation * Meeting the extubation readiness criteria per the attending neonatologist

Exclusion criteria

* Known major congenital disease (chromosomal abnormality, heart disease, respiratory malformation) * Neonates with parents that are less than 18 years old

Design outcomes

Primary

Measure	Time frame	Description
Ability of lung ultrasound score to predict extubation success	12 hours pre-extubation to 24 hours post extubation	Correlate the lung ultrasound score to the success of extubation, which is defined as remaining extubated for \>72 hours. Ultrasound scores are measured on a 4-point scale (0=normal,3 = most abnormal).

Secondary

Measure	Time frame	Description
Change in pre- and post-extubation lung ultrasound scores	12 hours pre-extubation to 24 hours post extubation	Ultrasound scores are measured on a 4-point scale (0=normal,3 = most abnormal).
Time to re-intubation	Up to 72 hours post-intubation	Length of time from extubation to re-intubation.
Change in heart rate	5 minutes before to 5 minutes after lung ultrasound	Measure of heart rate before and after ultrasound procedure
Change in respiratory rate	5 minutes before to 5 minutes after lung ultrasound	Measure of respiratory rate before and after ultrasound procedure
Change in oxygen saturation	5 minutes before to 5 minutes after lung ultrasound	Measure of oxygen saturation before and after ultrasound procedure

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAdam S Bauer, MD

Meriter Foundation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 19, 2026