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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06901206




Registration number
NCT06901206
Ethics application status
Date submitted
10/03/2025
Date registered
28/03/2025

Titles & IDs
Public title
Neonatologist-Performed Lung Ultrasound (NPLUS) to Guide Respiratory Therapy
Scientific title
Neonatologist-Performed Lung Ultrasound (NPLUS) to Guide Respiratory Therapy on Non-Invasive Ventilation in Preterm Infants
Secondary ID [1] 0 0
2024/PID01756
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
PreTerm Neonate 0 0
Respiratory Distress Syndrome (RDS) 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Reproductive Health and Childbirth 0 0 0 0
Complications of newborn
Reproductive Health and Childbirth 0 0 0 0
Childbirth and postnatal care
Reproductive Health and Childbirth 0 0 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Neonatologist performed lung ultrasound

Active comparator: NPLUS - 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.

No intervention: Control - Routine Care


Treatment: Surgery: 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.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean ratio res/base (Resolution FiO2 / Baseline FiO2)
Timepoint [1] 0 0
Resolution FiO2 assessed 1 hour after increased persisting (>10 min) FiO2 demand (absolute increase = 10% over the FiO2 baseline)
Secondary outcome [1] 0 0
Mean FiO2 (within 48-hour blocks)
Timepoint [1] 0 0
48 hours
Secondary outcome [2] 0 0
FiO2 between T0 and T1
Timepoint [2] 0 0
Assessed 1 hour after increased persisting (>10 minutes) FiO2 demand (absolute increase = 10% over the FiO2 baseline)
Secondary outcome [3] 0 0
LUS between T0 and T1
Timepoint [3] 0 0
Assessed 1 hour after increased persisting (>10 minutes) FiO2 demand (absolute increase = 10% over the FiO2 baseline)
Secondary outcome [4] 0 0
Number of changes in ventilatory settings (PEEP)
Timepoint [4] 0 0
48 hours
Secondary outcome [5] 0 0
SpO2/FiO2 ratio
Timepoint [5] 0 0
48 hours
Secondary outcome [6] 0 0
Routinely obtained capillary blood gas analysis (pH, pCO2)
Timepoint [6] 0 0
48 hours
Secondary outcome [7] 0 0
Number of chest X-rays and NPLUS examinations, number of chest X-ray based interventions, number of NPLUS based interventions.
Timepoint [7] 0 0
48 hours
Secondary outcome [8] 0 0
Number of recruitment maneuvers
Timepoint [8] 0 0
48 hours
Secondary outcome [9] 0 0
Time to detect impairment of lung aeration (consolidations).
Timepoint [9] 0 0
48 hours

Eligibility
Key inclusion criteria
* 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.
Minimum age
1 Week
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/03/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2026
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Newborn Intensive Care Unit, Royal Hospital for Women - Sydney
Recruitment postcode(s) [1] 0 0
2031 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Royal Hospital For Women
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Medical University of Graz
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Tim Schindler BMedSc MBBS FRACP PhD
Address 0 0
Senior Staff Specialist, Royal Hospital for Women, Conjoint Associate Professor, University of New South Wales
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Tim Schindler BMedSc MBBS FRACP PhD
Address 0 0
Country 0 0
Phone 0 0
+61293826190
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06901206