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

NCT06901206 | Not Yet Recruiting

• 1 other identifier: 2024/PID01756
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

NPLUS; Neonatologist performed lung ultrasound; lung ultrasound score; CPAP; loss of aeration; atelectasis; preterm neonate; respiratory distress syndrome

Outcome Measures

Primary Outcomes (1)

• Mean ratio res/base (Resolution FiO2 / Baseline FiO2)

  For each subject a baseline FiO2 is established for the control and NPLUS periods. Each episode of increased persisting (\>10 min) FiO2 demand (absolute increase ≥ 10% over the FiO2 baseline) on non-invasive ventilation is defined as event. The aim of using NPLUS versus standard care (control) when managing an event is to reduce any increase from the subject's baseline in the resolution FiO2 level associated with the event. The ratio of the FiO2 at resolution of each event to baseline FiO2 is a continuous measurement which is 1 when the resolution FiO2 equals the subject's baseline value. A ratio of 1.2 means the resolution FiO2 for the event is 20% higher than the subject's baseline FiO2, a ratio \<1 indicates the resolution FiO2 for the event is less than the subject's baseline and so on.

  Resolution FiO2 assessed 1 hour after increased persisting (>10 min) FiO2 demand (absolute increase ≥ 10% over the FiO2 baseline)

Secondary Outcomes (9)

• Mean FiO2 (within 48-hour blocks)

  48 hours

• FiO2 between T0 and T1

  Assessed 1 hour after increased persisting (>10 minutes) FiO2 demand (absolute increase ≥ 10% over the FiO2 baseline)

• LUS between T0 and T1

  Assessed 1 hour after increased persisting (>10 minutes) FiO2 demand (absolute increase ≥ 10% over the FiO2 baseline)

• Number of changes in ventilatory settings (PEEP)

  48 hours

• SpO2/FiO2 ratio

  48 hours

Study Arms (2)

NPLUS

ACTIVE COMPARATOR

In the NPLUS block, 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.

Procedure: Neonatologist performed lung ultrasound

Control

NO INTERVENTION

Routine Care

Interventions

Neonatologist performed lung ultrasound PROCEDURE

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.

NPLUS

Eligibility Criteria

• Age: 1 Week+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All preterm infants (\<33 weeks gestational age) from their 2nd week of life, receiving respiratory support via NCPAP
• expected to stay on NCPAP for the following 5 days at the NICU, Royal Hospital for Women, Randwick, Sydney
• provided written informed consent obtained from parents.

You may not qualify if:

• Neonates with previous abdominal surgery
• Major congenital anomalies.
• \>33+0 weeks
• Less than 1 week of age
• Invasive ventilation
• Bilevel or Multilevel non-invasive ventilation
• Not expected respiratory support via CPAP for the following 5 days.

Sponsors & Collaborators

• Royal Hospital For Women: lead
• Medical University of Graz: collaborator

Study Sites (1)

Newborn Intensive Care Unit, Royal Hospital for Women

Sydney, New South Wales, 2031, Australia

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome; Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Tim Schindler BMedSc MBBS FRACP PhD

  Senior Staff Specialist, Royal Hospital for Women, Conjoint Associate Professor, University of New South Wales

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tim Schindler BMedSc MBBS FRACP PhD

CONTACT

+61293826190; tim.schindler@health.nsw.gov.au

Viktoria Gruber, Dr.med.univ.

CONTACT

+436649703521; vi.gruber@medunigraz.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Staff Specialist, Royal Hospital for Women; Conjoint Associate Professor, University of New South Wales

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 28, 2025
• Study Start: March 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)