Lung Ultrasound - Prospective Study

NCT ID: NCT06140615

Last Updated: 2025-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-11

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Respiratory Distress of Newborn

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Lung ultrasound

Participants undergo pre- and post-extubation lung ultrasound

Group Type EXPERIMENTAL

Ultrasound

Intervention Type DEVICE

Ultrasound of lungs

Interventions

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Ultrasound

Ultrasound of lungs

Intervention Type DEVICE

Eligibility Criteria

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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
Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Meriter Foundation

OTHER

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adam S Bauer, MD

Role: PRINCIPAL_INVESTIGATOR

Meriter Foundation

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status RECRUITING

Unity-Point Health Meriter

Madison, Wisconsin, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Adam S Bauer, MD

Role: CONTACT

608-417-6411

Meg Baker

Role: CONTACT

Other Identifiers

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2023-026

Identifier Type: OTHER

Identifier Source: secondary_id

non-PBA dated 7/8/24

Identifier Type: OTHER

Identifier Source: secondary_id

2023-1132

Identifier Type: OTHER

Identifier Source: secondary_id

2024-1751

Identifier Type: -

Identifier Source: org_study_id

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