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Ultrasonic DiagnosisNCT02449863

Lung Ultrasound as a Predictor of Mechanical Ventilation in Neonates Older Than 32 Weeks

An observational study of Ultrasonic Diagnosis, run by Hospital Sant Joan de Deu at 2 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Neonatal respiratory distress prognosis may be difficult to estimate at admission. Lung ultrasound is a useful diagnostic tool that is quick, requires little training and is radiation free. This study analyzes whether early lung ultrasound can predict respiratory failure. Read more about this study

Who is it for?
Ages 32 weeks and older
Conditions the study is for
Ultrasonic Diagnosis
What is being tested?
Lung ultrasound
How many people
105 participants
Where
2 sitesSpain
Study dates
Jan 2014to Dec 2014
How long will I take part?
2 Days
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 32 weeks and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients older than 32 weeks admitted to the neonatal intensive care unit with respiratory distress who were not on invasive mechanical ventilation (MV) were eligible for recruitment.

Who may be able to join

  • Patients older than 32 weeks admitted to the neonatal intensive care unit with respiratory distress who were not on invasive mechanical ventilation (MV) were eligible for recruitment.

Who cannot join

  • Patients younger than 32 weeks
  • Patients with mechanic ventilation ar admission

Trial locations and contacts

2 sites in 1 country.

Spain2 sites
  • Hospital Sant Joan de Déu

    Esplugues de Llobregat

  • Javier Rodriguez Fanjul

    Esplugues de Llobregat

Other trials in Spain

About this study

Neonatal respiratory distress prognosis may be difficult to estimate at admission. Lung ultrasound is a useful diagnostic tool that is quick, requires little training and is radiation free. This study analyzes whether early lung ultrasound can predict respiratory failure.

Read the detailed description

Neonatal respiratory distress prognosis may be difficult to estimate at admission. Lung ultrasound is a useful diagnostic tool that is quick, requires little training and is radiation free. This study analyzes whether early lung ultrasound can predict respiratory failure.

Methods This study was conducted from January to December 2014 at Hospital Sant Joan de Déu (Esplugues de Llobregat, Barcelona, Spain), a third-level hospital with 3300 births per year and a neonatal intensive care unit with annual admission of 700 patients.

Local institutional review board of Hospital Sant Joan de Déu approved the protocol (project approval number PIC-07-15) and written informed consent was obtained from all parents.

Patients older than 32 weeks admitted to the neonatal intensive care unit with respiratory distress who were not on invasive mechanical ventilation (MV) were eligible for recruitment.

A single operator, a neonatologist skilled in lung and heart sonography, performed the examinations. Images were then analysed by another neonatologist with less experience in LUS. He was blind to the perinatal history and chest radiography of the newborns and unaware of the clinical diagnosis. Infants were from a non-consecutive convenience sample recruited when the operator was available for the execution of LUS in the first 2 hours of life.

Examinations were performed with a portable device (Siemens Acuson X) using a 10MHz linear probe and previously warmed gel. Eight video clips were stored at each examination, which was performed at the patient's bedside, with the neonate placed in a supine position. In each hemithorax 4 regions were evaluated: parasternal area, anterolateral axillary area, posterior axillary area, and the fifth intercostal space, by means of a transversal scan. The LUS procedures were carried out in 1.5-2 minutes.

Infants were classified into 2 groups, according to the LUS pattern:

  • Low risk: Normal, transient tachypnea of the newborn.
  • High risk: Respiratory distress syndrome, meconium aspiration syndrome, pneumothorax, pneumonia.

A second investigator made the same classification after reading chest x-ray pictures. Respiratory failure was defined as the need for invasive mechanical ventilation during the first day of life.

A single consultant, a neonatologist expert in lung disease, also blinded to the patient's perinatal history and clinical condition, made the x-ray diagnosis.

Finally, another consultant neonatologist made the final clinical diagnosis taking into account complete patient's medical history except LUS information.

Perinatal and anthropometric data (gestational age, weight, sex, antenatal steroids, and delivery method) were collected from clinical charts and data regarding neonatal respiratory evolution (hours of oxygen and ventilation, respiratory support-NIV, conventional MV, high frequency oscillatory ventilation or extracorporeal membrane oxygenation-and need for surfactant) were collected during admission.

Statistics All data were analysed using IBM SPSS version 20.0 (IBM Corporation, USA). Clinical features and respiratory outcomes were summarized using descriptive statistics (frequency distribution for categorical data and mean and standard deviation or median and interquartile range for continuous data). Univariate analysis included the Chi-square test and Fisher's exact test, as appropriate, for categorical comparisons, and t-Student or Mann-Whitney test for continuous variables. Wilson method was used to compute confidence interval (CI). Cohen´s kappa coefficient was provided to assess agreement between sonographic and radiologic risk patterns. Predictive values and related parameters (sensibility, specificity and likelihood ratios) were calculated for both diagnostic tests (sonographic pattern risk and radiologic pattern risk); ROC analysis was used to assess efficiency. CI of Area Under the Curve was obtained by the exact method (Clopper-Pearson). All hypothesis tests were two sided and p value less than 0.05 were considered statistically significant.

Being tested
Lung ultrasound
Keywords
Lung ultrasound, Mechanical ventilation, Respiratory distress syndrome, Transient tachypnea of the newborn
Medical subject headings
Respiratory Distress Syndrome, Transient Tachypnea of the Newborn

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lung ultrasoundOther

    Lung ultrasound performed to newborns with respiratory distress

Study groups in NCT02449863
Study groupRoleWhat they receive
Low risk ultrasoundPatients with a low risk ultrasound
Receives: Other: Lung ultrasound
High risk ultrasoundPatients with a high risk ultrasound
Receives: Other: Lung ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. investigate whether LUS performed during the first 2 hours of life is a useful tool to predict respiratory failure of neonates older than 32 weeks with respiratory distress

    Measured: 2 hours of life

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2015 (estimated)
  2. Study startJan 2014
  3. Primary completionDec 2014
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
105 participants (actual)
Target duration
2 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT02449863
Sponsor's protocol ID
PIC-07-15
Status last verified
May 2015
First submitted
18 May 2015
Last updated
20 May 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Ultrasonic Diagnosis, run by Hospital Sant Joan de Deu at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

investigate whether LUS performed during the first 2 hours of life is a useful tool to predict respiratory failure of neonates older than 32 weeks with respiratory distress (time frame: 2 hours of life). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2015.

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