Preterm BirthNCT02493920
Sustained Lung Inflation and Pulmonary Mechanics in Preterm Infant
A study testing Sustained lung inflation and mask using a T-piece system (Fabian,Acutronic Medical Systems AG, Switzerland). in people with Preterm Birth and Respiratory Distress Syndrome, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico.
Trial summary
Lung protection should start in the delivery room where, from the first breaths, the preterm infant can be helped to clear the lung fluid and to recruit alveolar spaces and establish the functional residual capacity (FRC). Read more about this study
- Who is it for?
- Ages 25 to 36 weeks
- Conditions the study is for
- Preterm Birth, Respiratory Distress Syndrome, Lung Diseases
- What is being tested?
- Sustained lung inflation and mask using a T-piece system (Fabian,Acutronic Medical Systems AG, Switzerland).
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Mar 2018
- Phase
- Interventional
- 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 25 to 36 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age (GA) at least 25 weeks but less than 36 completed weeks by best obstetrical estimate
Who cannot join
- Refusal of antenatal informed consent
- Known major anomalies, pulmonary hypoplasia
- Severe perinatal suffering
About this study
Official title: Evaluation of Pulmonary Mechanics in Preterm Infant Treated With Sustained Lung Inflation at Birth
Lung protection should start in the delivery room where, from the first breaths, the preterm infant can be helped to clear the lung fluid and to recruit alveolar spaces and establish the functional residual capacity (FRC). Sustained lung inflation (SLI) applied at birth in the delivery room has been demonstrated to lead to clearance of lung fluid and achievement of a precocious functional residual capacity (FRC) both in animal and human studies. SLI associated to an adequate positive end expiratory pressure (PEEP) may help the efficacy of the respiratory effort in lung of preterm infants at risk for respiratory distress syndrome (RDS) and reduce need of mechanical ventilation (MV).
Further studies are required to evaluate the clinical utility of this maneuver. The ability to monitor what happens to the lungs while applying different recruitment maneuvers in preterm infants would allow the definition of a procedure that allows optimal assistance to improve the FRC. One promising approach is provided by the forced oscillation technique (FOT). During forced oscillations, a small amplitude sinusoidal pressure stimulus is applied to the airway opening and the mechanical response of the respiratory system is studied by means of the total respiratory input impedance (Zin). Zin is a complex number that can be expressed as real part, called resistance (Rrs), and imaginary part, called reactance (Xrs). Particularly, it has been recently shown that Xrs measured at 5 Hz is very sensible to changes in the mechanics of lung periphery and provides accurate information about lung volume recruitment and derecruitment. The main purpose of this work is to apply FOT to the assessment of lung function in newborns submitted to SLI at birth. The investigators hypothesized that the application in the delivery room of the SLI in the preterm infant is effective in achieving a greater FRC and therefore a greater value of Xrs compared to a control group not treated with the SLI.
- Conditions
- Preterm Birth, Respiratory Distress Syndrome, Lung Diseases
- Being tested
- Sustained lung inflation, mask using a T-piece system (Fabian,Acutronic Medical Systems AG, Switzerland).
- Keywords
- Respiratory Distress Syndrome, Newborn, Delivery Room, Resuscitation, Premature birth, Infant, Newborn, Respiration Artificial
- Medical subject headings
- Premature Birth, Respiratory Distress Syndrome, Lung Diseases, Respiratory Distress Syndrome, Newborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sustained lung inflationOther
Also called lung recruitment
Sustained lung inflation (SLI) will be performed with mask using a T-piece system (Fabian,Acutronic Medical Systems AG, Switzerland).Peak inflation pressure (PIP) of 25 cm H2O will be delivered for 15 seconds and then reduced to a PEEP of 5 cm H2O. A second SLI manoeuvre will be repeated in case of persistent hearth failure (HR <100 bpm).
mask using a T-piece system (Fabian,Acutronic Medical Systems AG, Switzerland).Device
| Study group | Role | What they receive |
|---|---|---|
| SLI group | Experimental | In this group the preterm infants will receive sustained lung inflation (SLI) with mask in the delivery room; the parameters of respiratory mechanics will be monitored for 5 minutes by means of the forced oscillation technique. Receives: Other: Sustained lung inflation; Device: mask using a T-piece system (Fabian,Acutronic Medical Systems AG, Switzerland). |
| Control | No intervention | Preterm infants will be assisted in the delivery room with a continuous positive airway pressure (CPAP) of 5 cmH2O with mask and the parameters of respiratory mechanics will be monitored for 5 minutes by means of the forced oscillation technique. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Reactance (Xrs) values measured by the forced oscillation technique (FOT)
Measured: Baseline and at 5 minutes of life (that is, before and at the end of the SLI)
Secondary outcomes (9)
Need for intubation within the first 72 hours of life
Measured: 72 hours of life
Duration of respiratory support (ventilation, CPAP, supplemental oxygen)
Measured: During hospitalization - up to 36 weeks Post Menstrual Age (PMA)
Death in hospital
Measured: During hospitalization - up to 40 weeks Post Menstrual Age (PMA)
Number of surfactant doses
Measured: During hospitalization - up to 36 weeks Post Menstrual Age (PMA)
Retinopathy of prematurity (ROP) stage 3 or greater requiring treatment
Measured: 40 weeks Post Menstrual Age (PMA)
Incidence of Patent Ductus Arteriosus (PDA) requiring treatment
Measured: During hospitalization - up to 36 weeks Post Menstrual Age (PMA)
Incidence of Bronchopulmonary dysplasia
Defined according to the criteria of Jobe and Bancalari (Jobe A, Bancalari E. Bronchopulmonary dysplasia. Am J Respir Crit Care Med 2001;163:1723-9)
Measured: 36 weeks Post Menstrual Age (PMA)
Incidence of Intracranial Hemorrhages (ICH)
We used the ICH classification of Papile et al
Measured: During hospitalization- up to 40 weeks Post Menstrual Age (PMA)
Length of hospital stay
Measured: Average discharge between 36 - 40 weeks PMA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2015 (estimated)
- Study startMar 2016 (estimated)
- Primary completionMar 2017 (estimated)
- Study completionMar 2018 (estimated)
Why it stopped: Technical problems, unreliability of the measured parameters
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariarosa Colnaghi, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Investigators
- Mariarosa Colnaghi, MD, Principal investigator, NICU, IRCCS Cà Granda, Ospedale Maggiore Policlinico, Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02493920
- Sponsor's protocol ID
- MECCANICA SLI
- Status last verified
- Feb 2021
- First submitted
- 23 Jun 2015
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pulmonary Mechanics in Preterm Infant Treated With Sustained Lung Inflation at Birth
- ClinicalTrials.gov ID
- NCT02493920
- Acronym / sponsor ID
- MECCANICA SLI
- Conditions
- Preterm Birth, Respiratory Distress Syndrome, Lung Diseases
- Keywords
- Respiratory Distress Syndrome, Newborn, Delivery Room, Resuscitation, Premature birth, Infant, Newborn, Respiration Artificial
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Technical problems, unreliability of the measured parameters
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- Mar 2016 (estimated)
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 10 Jul 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.
Lung protection should start in the delivery room where, from the first breaths, the preterm infant can be helped to clear the lung fluid and to recruit alveolar spaces and establish the functional residual capacity (FRC). Sustained lung inflation (SLI) applied at birth in the delivery room has been demonstrated to lead to clearance of lung fluid and achievement of a precocious functional residual capacity (FRC) both in animal and human studies. SLI associated to an adequate positive end expiratory pressure (PEEP) may help the efficacy of the respiratory effort in lung of preterm infants at risk for respiratory distress syndrome (RDS) and reduce need of mechanical ventilation (MV).
Further studies are required to evaluate the clinical utility of this maneuver. The ability to monitor what happens to the lungs while applying different recruitment maneuvers in preterm infants would allow the definition of a procedure that allows optimal assistance to improve the FRC. One promising approach is provided by the forced oscillation technique (FOT). During forced oscillations, a small amplitude sinusoidal pressure stimulus is applied to the airway opening and the mechanical response of the respiratory system is studied by means of the total respiratory input impedance (Zin). Zin is a complex number that can be expressed as real part, called resistance (Rrs), and imaginary part, called reactance (Xrs). Particularly, it has been recently shown that Xrs measured at 5 Hz is very sensible to changes in the mechanics of lung periphery and provides accurate information about lung volume recruitment and derecruitment. The main purpose of this work is to apply FOT to the assessment of lung function in newborns submitted to SLI at birth. The investigators hypothesized that the application in the delivery room of the SLI in the preterm infant is effective in achieving a greater FRC and therefore a greater value of Xrs compared to a control group not treated with the SLI.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SLI group | Experimental | Other: Sustained lung inflation, Device: mask using a T-piece system (Fabian,Acutronic Medical Systems AG, Switzerland).In this group the preterm infants will receive sustained lung inflation (SLI) with mask in the delivery room; the parameters of respiratory mechanics will be monitored for 5 minutes by means of the forced oscillation technique. |
| Control | No intervention | –Preterm infants will be assisted in the delivery room with a continuous positive airway pressure (CPAP) of 5 cmH2O with mask and the parameters of respiratory mechanics will be monitored for 5 minutes by means of the forced oscillation technique. |
Who may qualify
- Ages
- 25 to 36 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Gestational age (GA) at least 25 weeks but less than 36 completed weeks by best obstetrical estimate
Key exclusion criteria (3 listed)
- Refusal of antenatal informed consent
- Known major anomalies, pulmonary hypoplasia
- Severe perinatal suffering
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 |
|---|---|---|
| Sustained lung inflationAlso: lung recruitmentSustained lung inflation (SLI) will be performed with mask using a T-piece system (Fabian,Acutronic Medical Systems AG, Switzerland).Peak inflation pressure (PIP) of 25 cm H2O will be delivered for 15 seconds and then reduced to a PEEP of 5 cm H2O. A second SLI manoeuvre will be repeated in case of persistent hearth failure (HR <100 bpm). | Other | SLI group |
| mask using a T-piece system (Fabian,Acutronic Medical Systems AG, Switzerland). | Device | SLI group |
Primary outcome
Change in Reactance (Xrs) values measured by the forced oscillation technique (FOT)
Time frame: Baseline and at 5 minutes of life (that is, before and at the end of the SLI)
9 secondary outcomes
Need for intubation within the first 72 hours of life
Time frame: 72 hours of life
Duration of respiratory support (ventilation, CPAP, supplemental oxygen)
Time frame: During hospitalization - up to 36 weeks Post Menstrual Age (PMA)
Death in hospital
Time frame: During hospitalization - up to 40 weeks Post Menstrual Age (PMA)
Number of surfactant doses
Time frame: During hospitalization - up to 36 weeks Post Menstrual Age (PMA)
Retinopathy of prematurity (ROP) stage 3 or greater requiring treatment
Time frame: 40 weeks Post Menstrual Age (PMA)
Incidence of Patent Ductus Arteriosus (PDA) requiring treatment
Time frame: During hospitalization - up to 36 weeks Post Menstrual Age (PMA)
Incidence of Bronchopulmonary dysplasia
Time frame: 36 weeks Post Menstrual Age (PMA)
Incidence of Intracranial Hemorrhages (ICH)
Time frame: During hospitalization- up to 40 weeks Post Menstrual Age (PMA)
Length of hospital stay
Time frame: Average discharge between 36 - 40 weeks PMA
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
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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.
Mariarosa Colnaghi, MD principal investigator
NICU, IRCCS Cà Granda, Ospedale Maggiore Policlinico, Milan
Questions about this trial
What is this clinical trial studying?
A study testing Sustained lung inflation and mask using a T-piece system (Fabian,Acutronic Medical Systems AG, Switzerland). in people with Preterm Birth and Respiratory Distress Syndrome, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico.
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 3 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: withdrawn, as of the sponsor's last update on 2 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Change in Reactance (Xrs) values measured by the forced oscillation technique (FOT) (time frame: Baseline and at 5 minutes of life (that is, before and at the end of the SLI)). 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 2 Mar 2021.