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Completed

NCT Number: NCT06140615

Lung Ultrasound - Prospective Study

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.

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Key information

Conditions

Respiratory Distress of Newborn Lung Diseases Pulmonary Atelectasis Respiratory Tract Diseases

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota, Minneapolis, Minnesota, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound

Device

Ultrasound of lungs

Primary outcomes

  1. Ability of lung ultrasound score to predict extubation success

    Time frame: 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 outcomes

  1. Change in pre- and post-extubation lung ultrasound scores

    Time frame: 12 hours pre-extubation to 24 hours post extubation

    Ultrasound scores are measured on a 4-point scale (0=normal,3 = most abnormal).

  2. Time to re-intubation

    Time frame: Up to 72 hours post-intubation

    Length of time from extubation to re-intubation.

  3. Change in heart rate

    Time frame: 5 minutes before to 5 minutes after lung ultrasound

    Measure of heart rate before and after ultrasound procedure

  4. Change in respiratory rate

    Time frame: 5 minutes before to 5 minutes after lung ultrasound

    Measure of respiratory rate before and after ultrasound procedure

  5. Change in oxygen saturation

    Time frame: 5 minutes before to 5 minutes after lung ultrasound

    Measure of oxygen saturation before and after ultrasound procedure

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • Meriter Foundation

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Nov 20, 2023
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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