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Neonatologist-Performed Lung Ultrasound (NPLUS) to Guide Respiratory Therapy

NCT06901206 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-03-28

No results posted yet for this study

Summary

The goal of this cross-over clinical trial is to evaluate whether Neonatologist-Performed Lung Ultrasound (NPLUS) can be used in preterm babies on non-invasive breathing support to reduce the amount of oxygen they need. The main question it aims to answer is:

When a baby's oxygen requirement goes up, does NPLUS help to target interventions and reduce oxygen requirements?

Researchers will compare NPLUS to standard treatment.

Participants will:

Have a lung ultrasound performed whenever their oxygen requirement increases by more than 10%.

The ultrasound findings will be used to target interventions that aim to improve air entry in the lungs.

Each time this happens, the researchers will note what happens to the oxygen requirement afterwards.

Each participant will participate for five days. For the first two days, they will be randomized to either the NPLUS arm or the usual care arm.

There is then a 24 hour period of usual care. For the final two days, participants cross over to the other arm of the trial.

Conditions

  • PreTerm Neonate
  • Respiratory Distress Syndrome (RDS)

Interventions

PROCEDURE

Neonatologist performed lung ultrasound

Neonatologist performed lung ultrasound is performed at T0 (reported persistent increased FiO2 demand) and T1 (one hour after T0). NPLUS may be able to detect loss of aeration and lead to more targeted interventions to improve lung aeration. A comprehensive lung ultrasound examination will take 5 minutes or less to perform and involves minimal handling for the patient.

Sponsors & Collaborators

  • Medical University of Graz

    collaborator OTHER

  • Royal Hospital For Women

    lead OTHER

Principal Investigators

  • Tim Schindler BMedSc MBBS FRACP PhD · Senior Staff Specialist, Royal Hospital for Women, Conjoint Associate Professor, University of New South Wales

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
1 Week
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-31
Primary Completion
2026-03-31
Completion
2026-06-30

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06901206 on ClinicalTrials.gov