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.
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
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.
- Conditions
- Ultrasonic Diagnosis
- 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 group | Role | What they receive |
|---|---|---|
| Low risk ultrasound | Patients with a low risk ultrasound Receives: Other: Lung ultrasound | |
| High risk ultrasound | Patients 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.
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.
- First posted20 May 2015 (estimated)
- Study startJan 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultrasonic DiagnosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Hospital Sant Joan de Deu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Javier Rodríguez-Fanjul, M.D., Principal investigator, Hospital Sant Joan de Déu. Esplugues de Llobregat. Spain
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
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Ultrasound as a Predictor of Mechanical Ventilation in Neonates Older Than 32 Weeks
- ClinicalTrials.gov ID
- NCT02449863
- Acronym / sponsor ID
- PIC-07-15
- Conditions
- Ultrasonic Diagnosis
- Keywords
- Lung ultrasound, Mechanical ventilation, Respiratory distress syndrome, Transient tachypnea of the newborn
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Hospital Sant Joan de DeuUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 20 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low risk ultrasound | – | Other: Lung ultrasoundPatients with a low risk ultrasound |
| High risk ultrasound | – | Other: Lung ultrasoundPatients with a high risk ultrasound |
Who may qualify
- Ages
- 32 weeks and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients younger than 32 weeks
- Patients with mechanic ventilation ar admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung ultrasoundLung ultrasound performed to newborns with respiratory distress | Other | High risk ultrasound, Low risk ultrasound |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javier Rodríguez-Fanjul, M.D. principal investigator
Hospital Sant Joan de Déu. Esplugues de Llobregat. Spain
2 sites in 1 country: see every site and its status.
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.