Noninvasive VentilationNCT02628821
The Effectiveness of Non-Invasive Ventilation Use in Preterm Infants.
An observational study of Noninvasive Ventilation and Preterm Infants, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.
Trial summary
Prospective observational study of SNIPPV use in preterm infants of less than 32weeks of gestation from January 2012 to December 2015. Previous respiratory status is analyzed as well as respiratory outcomes and possible secondary side effects. Read more about this study
- Who is it for?
- Ages 1 minute to 3 months
- Conditions the study is for
- Noninvasive Ventilation, Preterm Infants
- What is being tested?
- Preterm Infants treated with non-invasive ventilation.
- How many people
- 45 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2012to Dec 2014
- 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 1 minute to 3 months
- All sexes
- No healthy volunteers
- Child
Study population: Prospective observational study of SNIPPV use in preterm infants of less than 32 weeks of gestation from January 2012 to December of 2014. SNIPPV is used for: * nCPAP failure: Preterm infants supported with nCPAP that meet intubation criteria (FiO2>50%; apnea spells more than 4/h or more than 1 that needs PPV) if they are in a stable situation. SAP (systemic arterial pressure)> P10 with preserved respiratory drive (no more than 6 apneas episodes per hour or more than 2 requiring PPI). * Electively For extubation: * Preterm infants in which nCPAP extubation has previously failed or Prolonged mechanical ventilation (more than 15 days) with high respiratory parameters (PMAP > 10 cmH2O and FiO2>35%).
Who may be able to join
- Preterm Infants of less than 32 weeks of GA in which SNIPPV is applied for nCPAP failure.
- Preterm Infants of less than 32 weeks of GA in which SNIPPV is applied electively for extubation.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Synchronized Non-Invasive Ventilation to Prevent Invasive Mechanical Ventilation Use in Preterm Infants.
Prospective observational study of SNIPPV use in preterm infants of less than 32weeks of gestation from January 2012 to December 2015. Previous respiratory status is analyzed as well as respiratory outcomes and possible secondary side effects.
SNIPPV is used to prevent Intubation in Infants in which nCPAP has already failed (Infants that met intubation criteria) and also is used electively for extubation when nCPAP extubation has previously failed or infants with Prolonged mechanical ventilation (more than 15 days) with high respiratory parameters (PMAP > 10 cmH2O and FiO2>35%).
Read the detailed description
SNIPPV is used to prevent Intubation in Infants in which nCPAP has already failed (Infants that met intubation criteria) and also is used electively for extubation when nCPAP extubation has previously failed or infants with Prolonged mechanical ventilation (more than 15 days) with high respiratory parameters (PMAP > 10 cmH2O and FiO2>35%).
- Conditions
- Noninvasive Ventilation, Preterm Infants
- Being tested
- Preterm Infants treated with non-invasive ventilation.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preterm Infants treated with non-invasive ventilation.Other
Also called (Giulia®, Neonatal Nasal Ventilator)
| Study group | Role | What they receive |
|---|---|---|
| Preterm Infants treated with non-invasive ventilation | Preterm Infants of less than 32 weeks of Gestational age treated with synchronized non-invasive ventilation (SNIPPV) to prevent intubation or extubation failure based in a prospective protocol:
* nCPAP failure: Preterm infants supported with nCPAP that meet intubation criteria if they are in a stable situation.
* Electively For extubation:
Preterm infants in which nCPAP extubation has previously failed or Prolonged mechanical ventilation (more than 15 days) with high respiratory parameters (PMAP > 10 cmH2O and FiO2>35%). Receives: Other: Preterm Infants treated with non-invasive ventilation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Avoid of Invasive Mechanical Ventilation in the next three days.
The rate of infants treated with non-invasisive ventilation that do not need to be intubated in the next three days.
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
Time on MV
Days on MV during hospitalitation
Measured: through study completion, an average of 1 year
Neurological impairment
Intraventricular hemorrhage grade 3 or 4 (papile´s classification)
Measured: through study completion, an average of 1 year
Rate of patients with air leaks
pulmonary air leak
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study startJan 2012
- 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 Noninvasive VentilationStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Gregorio Marañon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel Sanchez Luna, Hospital General Universitario Gregorio Marañon
- Investigators
- Cristina Ramos-Navarro, Principal investigator, Gregorio Marañón Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02628821
- Sponsor's protocol ID
- 02/2015
- Status last verified
- Aug 2021
- First submitted
- 7 Dec 2015
- Last updated
- 27 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Synchronized Non-Invasive Ventilation to Prevent Invasive Mechanical Ventilation Use in Preterm Infants.
- ClinicalTrials.gov ID
- NCT02628821
- Acronym / sponsor ID
- 02/2015
- Conditions
- Noninvasive Ventilation, Preterm Infants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Hospital General Universitario Gregorio MarañonUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 11 Dec 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.
Prospective observational study of SNIPPV use in preterm infants of less than 32weeks of gestation from January 2012 to December 2015. Previous respiratory status is analyzed as well as respiratory outcomes and possible secondary side effects.
SNIPPV is used to prevent Intubation in Infants in which nCPAP has already failed (Infants that met intubation criteria) and also is used electively for extubation when nCPAP extubation has previously failed or infants with Prolonged mechanical ventilation (more than 15 days) with high respiratory parameters (PMAP > 10 cmH2O and FiO2>35%).
Detailed description
SNIPPV is used to prevent Intubation in Infants in which nCPAP has already failed (Infants that met intubation criteria) and also is used electively for extubation when nCPAP extubation has previously failed or infants with Prolonged mechanical ventilation (more than 15 days) with high respiratory parameters (PMAP > 10 cmH2O and FiO2>35%).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preterm Infants treated with non-invasive ventilation | – | Other: Preterm Infants treated with non-invasive ventilation.Preterm Infants of less than 32 weeks of Gestational age treated with synchronized non-invasive ventilation (SNIPPV) to prevent intubation or extubation failure based in a prospective protocol: * nCPAP failure: Preterm infants supported with nCPAP that meet intubation criteria if they are in a stable situation. * Electively For extubation: Preterm infants in which nCPAP extubation has previously failed or Prolonged mechanical ventilation (more than 15 days) with high respiratory parameters (PMAP > 10 cmH2O and FiO2>35%). |
Who may qualify
- Ages
- 1 minute to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Prospective observational study of SNIPPV use in preterm infants of less than 32 weeks of gestation from January 2012 to December of 2014. SNIPPV is used for: * nCPAP failure: Preterm infants supported with nCPAP that meet intubation criteria (FiO2>50%; apnea spells more than 4/h or more than 1 that needs PPV) if they are in a stable situation. SAP (systemic arterial pressure)> P10 with preserved respiratory drive (no more than 6 apneas episodes per hour or more than 2 requiring PPI). * Electively For extubation: * Preterm infants in which nCPAP extubation has previously failed or Prolonged mechanical ventilation (more than 15 days) with high respiratory parameters (PMAP > 10 cmH2O and FiO2>35%).
Key inclusion criteria (2 listed)
- Preterm Infants of less than 32 weeks of GA in which SNIPPV is applied for nCPAP failure.
- Preterm Infants of less than 32 weeks of GA in which SNIPPV is applied electively for extubation.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Preterm Infants treated with non-invasive ventilation.Also: (Giulia®, Neonatal Nasal Ventilator) | Other | Preterm Infants treated with non-invasive ventilation |
Primary outcome
Avoid of Invasive Mechanical Ventilation in the next three days.
Time frame: through study completion, an average of 1 year
The rate of infants treated with non-invasisive ventilation that do not need to be intubated in the next three days.
3 secondary outcomes
Time on MV
Time frame: through study completion, an average of 1 year
Neurological impairment
Time frame: through study completion, an average of 1 year
Rate of patients with air leaks
Time frame: through study completion, an average of 1 year
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 27 Aug 2021.
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Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
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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.
Cristina Ramos-Navarro principal investigator
Gregorio Marañón Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Noninvasive Ventilation and Preterm Infants, run by Hospital General Universitario Gregorio Marañon at 1 site 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 2 inclusion and 0 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 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Avoid of Invasive Mechanical Ventilation in the next three days. (time frame: through study completion, an average of 1 year). 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 27 Aug 2021.