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RecruitingNCT06425107Bacon-PocusUpdated May 22, 2024

Point-of-Care Lung Ultrasound for Prognosis in Critically Ill Infants With Acute Lower Respiratory Tract Infection

An observational study in Bronchiolitis and Noninvasive Ventilation, sponsored by Vittore Buzzi Children's Hospital. Recruiting at 1 site in Italy. Open to participants aged 0 Months to 12 Months. Per ClinicalTrials.gov, last updated 2024-05-22.

Sponsored by Vittore Buzzi Children's Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Started Jan 2024; still recruiting 2 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
0 Months to 12 Months
Sex
All
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Study summary

Prospective, observational multicentric study which aims at identifying lung POCUS (Point of Care UltraSound) findings associated with failure of noninvasive ICU-LRS (Intensive Care Unit Level Respiratory Support) (defined as escalation of settings or need for intubation and invasive mechanical ventilation) in infants requiring noninvasive ICU-LRS in the ICU for bronchiolitis and other LRTI (Low Respiratory Tract Infection) and at identifying lung, pleural, and diaphragm POCUS findings that are associated with a clinical improvement after escalation of ICU-LRS support by comparing POCUS findings from the first 24 hours of ICU stay to a subsequent study 1 day later.

Read the detailed description

Lower respiratory tract infections, primarily viral bronchiolitis, are a common cause of PICU admission for infants. While overall hospitalization rates for bronchiolitis are declining, ICU admission rates are actually increasing. The trend in respiratory management of critically ill infants with LRTIs has shifted from frequent invasive mechanical ventilation to more common use of non-invasive modalities, including CPAP, BiPap, and HFNC. Currently, the overwhelming majority of infants requiring ICU-level respiratory support (ICU-LRS) for bronchiolitis receive only noninvasive support.

During the past decade, point-of-care lung ultrasound (POCUS) is increasingly being used in both adults and children to enhance diagnostic and prognostic ability in respiratory failure. Lung POCUS is appealing due to the lack of radiation exposure compared to x-rays, the added sensitivity and specificity that it can add compared to traditional imaging to help differentiate consolidation from atelectasis from edema (may all have similar appearance on x-rays), the dynamic nature of the study to evaluate the lung parenchyma, pleura, and diaphragm, and the fact that it can be easily applied and repeated at the bedside to guide adjustments to therapies and evaluate their response. Lung POCUS differs from traditional radiology-based lung ultrasound in that it is focused and goal-directed, is frequently performed serially by the clinician managing the patient at the bedside, and is frequently used to immediately direct care decisions in real-time.

While lung POCUS is quickly becoming a standard of care for adults with respiratory failure, pediatric data, particularly in critically ill infants with bronchiolitis and other lower respiratory tract infections (LRTI) is largely lacking. Investigators from some sites within the BACON research group have begun to evaluate the role of lung POCUS in infants with bronchiolitis. These studies have primarily focused on the emergency department, but they have identified POCUS findings that are associated with clinical deterioration and have developed a pediatric lung ultrasound score that can predict infants who will require ICU-LRS. There are only two pediatric ICU bronchiolitis studies-one looking at the lung/pleura but in invasively ventilated patients only, and the other focused on the diaphragm in patients requiring noninvasive support.

Unfortunately, there are minimal data on infants in the ICU with bronchiolitis, and all of these prior studies are limited by low sample size. Thus, there is a significant knowledge gap about the ability of lung POCUS and these previously identified findings and scoring systems to accurately predict failure of noninvasive ICU-LRS for infants in the ICU with bronchiolitis and other LRTIs. Furthermore, there are no data evaluating the role of lung POCUS in identifying patients who will have a favorable response to adjustments in ICU-LRS settings.

Endpoints of the study are:

1, To identify lung POCUS findings associated with failure of noninvasive ICU-LRS (defined as escalation of settings or need for intubation and invasive mechanical ventilation) in infants requiring noninvasive ICU-LRS in the ICU for bronchiolitis and other LRTI.

  1. To identify lung, pleural, and diaphragm POCUS findings that are associated with a clinical improvement after escalation of ICU-LRS support by comparing POCUS findings from the first 24 hours of ICU stay to a subsequent study 1 day later.

There are no specific safety endpoints for this observational study. Families could end participation by their infant at any time, and the treating physician or investigator could withdraw the patient from the study but there are no pre-specified safety endpoints.

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Conditions studied

  • Bronchiolitis
  • Noninvasive Ventilation

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03

In context

Bronchiolitis

289 studies on the registry are indexed under Bronchiolitis; 51 are open to participants now.

This study's planned enrollment of 100 is below the median of 200 across 79 observational studies indexed under Bronchiolitis.

Browse Bronchiolitis studies →

Lead sponsor

Vittore Buzzi Children's Hospital is the lead sponsor of 10 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
0 Months to 12 Months
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Infants \<1 year old admitted to the ICU for bronchiolitis and other lower respiratory tract infection who require noninvasive respiratory support

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age \<1 year at the time of hospital admission
  2. Admission to PICU for suspected/confirmed LRTI
  3. Treatment (within the 1st 12 hours of ICU stay) with noninvasive ICU-LRS for respiratory failure (HFNC >1L/kg/min, negative pressure, or noninvasive PPV via any interface (CPAP, BiPap, NIMV, etc.)

Exclusion criteria

Exclusion Criteria:

  1. Invasive ventilation as initial support or within the 1st 12 hours of ICU stay, either via endotracheal tube or tracheostomy
  2. Upper respiratory symptoms only (stridor, stertor)
  3. Corrected gestational age \<37 weeks at time of ICU admission
  4. ICU-LRS for only nonrespiratory reasons (e.g. shock) or for pulmonary edema felt to be solely due to noninfectious causes (cardiogenic, airway obstruction, drowning). Patients presenting with apnea can be included if they have a diagnosis of bronchiolitis or other LRTI
  5. Prior inclusion in the study
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Lung Ultrasound findings associated with failure of noninvasive ICU-LRS (defined as escalation of settings or need for intubation and invasive mechanical ventilation) in infants requiring noninvasive ICU-LRS in the ICU for bronchiolitis and other LRTI.

    Ultrasound findings will be graded according to the scale proposed by the Italian Academy of thoracic Ultrasound: 0: normal A lines 1. short vertical artifacts and isolated B lines 2. multiple B lines (B lines with a distance of less than half centimeter to the confluence, remaining identifiable from each other) 3. white lung (subpleural field with various shades of grey/white without distinguishing B lines) and subpleural consolidations smaller than 1 cm 4. subpleural consolidations bigger than 1 cm

    Time frame: First 24 hours after ICU admission

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Study locations

1 of 1 sites recruiting
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References and documents

Publications

  • Caiulo VA, Gargani L, Caiulo S, Fisicaro A, Moramarco F, Latini G, Picano E. Lung ultrasound in bronchiolitis: comparison with chest X-ray. Eur J Pediatr. 2011 Nov;170(11):1427-33. doi: 10.1007/s00431-011-1461-2. Epub 2011 Apr 6. PubMed 21468639 ↗
  • Gori L, Amendolea A, Buonsenso D, Salvadori S, Supino MC, Musolino AM, Adamoli P, Coco AD, Trobia GL, Biagi C, Lucherini M, Leonardi A, Limoli G, Giampietri M, Sciacca TV, Morello R, Tursi F, Soldati G, Ecobron Group. Prognostic Role of Lung Ultrasound in Children with Bronchiolitis: Multicentric Prospective Study. J Clin Med. 2022 Jul 21;11(14):4233. doi: 10.3390/jcm11144233. PubMed 35887997 ↗
  • Musolino AM, Toma P, De Rose C, Pitaro E, Boccuzzi E, De Santis R, Morello R, Supino MC, Villani A, Valentini P, Buonsenso D. Ten Years of Pediatric Lung Ultrasound: A Narrative Review. Front Physiol. 2022 Jan 6;12:721951. doi: 10.3389/fphys.2021.721951. eCollection 2021. PubMed 35069230 ↗
  • Amendolea A, Gori L, Adamoli P, Limoli G, Supino MC, Coco AD, Trobia GL, Tursi F, Soldati G, Buonsenso D; Gruppo di studio Pediatrico AdET. Pleuropulmonary Ultrasound in Pediatrics: Proposal of a Reporting Model From the Academy of Thoracic Ultrasound. J Ultrasound Med. 2022 Oct;41(10):2637-2641. doi: 10.1002/jum.15924. Epub 2021 Dec 29. PubMed 34964991 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06425107
Lead sponsor
Vittore Buzzi Children's Hospital
Responsible party
Anna Camporesi (Principal Investigator, Vittore Buzzi Children's Hospital) — Principal investigator
First posted
May 22, 2024
Start date
Jan 1, 2024
Primary completion
Dec 31, 2024 (estimated)
Completion
Jun 30, 2025 (estimated)
Last update
May 22, 2024

Study contacts

Anna Camporesi, MD
Contact
anna.camporesi@gmail.com
+393355793744

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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