Lung Ultrasound-Guided Respiratory Management in Infants (NeoLUS-RCT)

January 26, 2026 updated by: Tufts Medical Center

Lung Ultrasound-Guided Respiratory Management in Infants: A Single-Center Randomized Controlled Trial

This single-center randomized controlled study will compare lung ultrasound-guided respiratory management with standard clinical care in infants requiring respiratory support.

The primary outcome measure is length of NICU stay.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Infants, especially premature infants, frequently require respiratory support in the neonatal intensive care unit (NICU). Lung ultrasound is a bedside, radiation-free tool that can assess lung aeration and guide respiratory management, but its effect on clinical outcomes has not been evaluated in a U.S. randomized trial.

This single-center randomized controlled study will compare lung ultrasound-guided respiratory management with standard clinical care in premature infants requiring respiratory support. In the intervention group, lung ultrasound scores will guide surfactant administration, weaning non-invasive respiratory support, and weaning from non-invasive respiratory support to room air using predefined thresholds. The control group will use standard care to guide surfactant administration, weaning non-invasive respiratory support, and weaning from non-invasive respiratory support to room air.

The primary outcome is length of NICU stay. Secondary outcomes include duration of respiratory support, time on non-invasive respiratory support, time to successful weaning to room air, need for re-intubation, surfactant dosing, and mortality prior to discharge. This study aims to determine whether lung ultrasound-guided management can improve respiratory care and reducive hospital length of stay in infants requiring respiratory suppport.

Study Type

Interventional

Enrollment (Estimated)

64

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Infants admitted to the Tufts Medical Center NICU
  • Requiring invasive or non-invasive respiratory support
  • Requiring surfactant therapy
  • Parental or guardian informed consent obtained

Exclusion Criteria:

  • Major congenital anomalies
  • Known chromosomal abnormalities
  • Congenital diaphragmatic hernia
  • Decision for comfort care
  • Surfactant administered prior to transfer from outside hospital (only excluded for surfactant decisions)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention - Lung ultrasound guided respiratory management

Participants randomized to this group will under lung ultrasound assessments at predefined clinical time points. Lung ultrasound scores will guide:

  • Surfactant administration in the early neonatal period
  • Weaning from non-invasive respiratory suppport
  • Transition to room air

Decisions will follow predefined lung ultrasound score thresholds using a validating scoring system. Ultrasounds to be performed by trained neonatal providers using standardized techniques. Attending neonatologists may override protocol recommendations if clinically necessary, with documentation
Procedure: Lung ultrasound-guided respiratory management
Scheduled lung ultrasounds are performed to guide decisions about surfactant administration, non-invasive respiratory support weaning, and transition to room air using predefined lung ultrasound score thresholds.
No Intervention: Control - Standard Clinical Care
Participants randomized to this group will receive respiratory management based on standard NICU clinical criteria including oxygen requirement, work of breathing, blood gas measurements, and radiographic findings. Lung ultrasound may be performed if clinically indicated, but will not be used for protocolized decision making.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Length of NICU stay (days)
Time Frame: From date of NICU admission to date of hospital discharge up to one year
From date of NICU admission to date of hospital discharge up to one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of any respiratory support
Time Frame: From date of initiation of respiratory support to date of discontinuation of respiratory support, up to one year
From date of initiation of respiratory support to date of discontinuation of respiratory support, up to one year
Duration of non-invasive respiratory support
Time Frame: From date of initiation of non-invasive respiratory support to date of discontinuation of non-invasive respiratory support up to one year.
From date of initiation of non-invasive respiratory support to date of discontinuation of non-invasive respiratory support up to one year.
Time to successful weaning to room air
Time Frame: From date of initiation of respiratory support to date of sustained room air without support for at least 48h, up to one year.
From date of initiation of respiratory support to date of sustained room air without support for at least 48h, up to one year.
Weaning failure
Time Frame: From date of weaning respiratory support, to date of re-escalation of respiratory support if needed, up to 72 hours
From date of weaning respiratory support, to date of re-escalation of respiratory support if needed, up to 72 hours
Need for reintubation
Time Frame: From date of extubation, to date of reintubation, up to 72 hours.
From date of extubation, to date of reintubation, up to 72 hours.
Number of surfactant doses administered
Time Frame: Number of surfactant doses quantified over the course through study completion, up to an average of 1 year.
Number of surfactant doses quantified over the course through study completion, up to an average of 1 year.
Mortality prior to discharge
Time Frame: From date of birth until the date of death from any cause, assessed up to one year.
From date of birth until the date of death from any cause, assessed up to one year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tufts Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

February 1, 2029

Study Registration Dates

First Submitted

January 20, 2026

First Submitted That Met QC Criteria

January 26, 2026

First Posted (Actual)

February 4, 2026

Study Record Updates

Last Update Posted (Actual)

February 4, 2026

Last Update Submitted That Met QC Criteria

January 26, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • STUDY00006737

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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