Neonatal Respiratory FailurePhase 3VNINSNCT01778829
Non Invasive Ventilation Versus Continuous Positive Airway Pressure After Extubation of Very Low Birth Weight Infants.
A Phase 3 study testing CPAP ventilation mode and NIPPV ventilation mode in people with Neonatal Respiratory Failure, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial summary
The purpose of this study is to determine whether Nasal intermittent positive pressure ventilation (NIPPV) non synchronized is better than continuous positive airway pressure (NCPAP)in preventing extubation failure within 72 h, after extubation of very low birth weight infants at the NEOCOSUR Network. Read more about this study
- Who is it for?
- Ages 2 hours to 14 days
- Conditions the study is for
- Neonatal Respiratory Failure
- What is being tested?
- CPAP ventilation mode and NIPPV ventilation mode
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteChile
- Study dates
- Dec 2011to Jun 2013
- Phase
- Phase 3
- 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 2 hours to 14 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm with a weight less than 1501 g
- Gestational age less or equal to 34 weeks
- Preterm that meets extubation criteria after at least 2 hours and less than 14 days connected to mechanical ventilation
- Patient receiving methylxanthynes
Who cannot join
- Patient more than 14 days in mechanical ventilation
- Newborn with congenital cardiopathy
- Newborn with congenital malformation
- Newborn wirh chromosomopathy or genopathic disease
- Newborn with suspected gastrointestinal disease
- Newborn with neuromuscular disease or receiving muscle relaxants
- Lack or informed consent signed by parents or legal representative
Trial locations and contacts
1 site in 1 country.
Alvaro Gonzalez, MD contact
Chile1 site, 1 recruiting
- Recruiting
Hospital Clinico, Pontificia Universidad Catolica de Chile
Santiago
Alberto Estay, MD, albertoestay@gmail.com
Alvaro Gonzalez, MD, alvgonza@med.puc.cl
About this study
Official title: Nasal Intermittent Mandatory Ventilation Versus Continuous Positive Airway Pressure After Extubation of Very Low Birth Weight Infants of the NEOCOSUR Network.
The purpose of this study is to determine whether Nasal intermittent positive pressure ventilation (NIPPV) non synchronized is better than continuous positive airway pressure (NCPAP)in preventing extubation failure within 72 h, after extubation of very low birth weight infants at the NEOCOSUR Network.
Read the detailed description
Is a Randomized trial to preterms infants <1500g and less than 34 weeks with RDS requiring machanical ventilation in the extubation period, randomized to receive NIPPV or NCPAP once extubation criteria were met. Parental written informed consent is required previous extubation. The failure rate is defined as the need for re-intubation and mechanical ventilation).
Exclusion criteria are: major congenital anomalies; presence of cardiovascular instability;intubation less than 2 hours; mechanical ventilation more than 14 days, using muscle relaxant, airway anomalies, consent not provided or refused.
Outcome measures:
The primary outcome was to assess the need for re-intubation within the first 72 hours after extubation in the 2 groups.
The criteria for failure were met by at least 1 of the following:
pH < 7.25 and PaCO2 > 65 mmHg; recurrent apnea more than 2 episodes per hour associated with bradycardia; during 4 hour continuous; 2 episodes of apnea that required bagand-mask ventilation in any time during the study; or a PaO2 < 50 mm Hg with a fraction of inspired oxygen > 0.6. The secondary outcomes concerning respiratory support were total duration on ETT ventilation, total duration on NCPAP, total duration on supplemental oxygen, incidence of pneumothorax,BPD and dead. Other outcomes included incidence of patent ductus arteriosus (PDA), necrotizing enterocolitis, intraventricular hemorrhage grades 3 and 4, retinopathy of prematurity stage 3, time to full feeds, and length of hospital stay.
Sample size calculations for the primary outcome: We estimated that there would be a more than 80% chance of detecting 43% difference between the groups (alpha 0.05) when samplesize (n) is 110 patients for each mode of treatment.
- Conditions
- Neonatal Respiratory Failure
- Being tested
- CPAP ventilation mode, NIPPV ventilation mode
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP ventilation modeProcedure or surgery
Patients are ventilated through a nasal prong coneected to a ventilator that provides a continuous positive airway pressure
NIPPV ventilation modeProcedure or surgery
Patients are ventilated through a nasal prong connected to a ventilator that provides a non synchronized intermittent positive pressure ventilation
| Study group | Role | What they receive |
|---|---|---|
| CPAP ventilation mode | Active comparator | Once the patient is extubated, CPAP ventilation mode is inmediately administered in order to prevent reintubation Receives: Procedure: CPAP ventilation mode |
| NIPPV ventilation mode | Experimental | NIPPV: Non Invasive Ventilation mode is administered inmediately after extubation to prevent reintubation Receives: Procedure: NIPPV ventilation mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extubation failure
The criteria for failure were met by at least 1 of the following:
pH less than 7.25 and PaCO2 over 65 mmHg; recurrent apnea more than 2 episodes per hour associated with bradycardia; during 4 hour continuous; 2 episodes of apnea that required bagand-mask ventilation in any time during the study; or a PaO2 less than 50 mm Hg with a fraction of inspired oxygen over 0.6.
Measured: apnea rate and respiratory failure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2013 (estimated)
- Study startDec 2011
- Primary completionMay 2013 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neonatal Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alberto Estay, Pontificia Universidad Catolica de Chile
- Investigators
- Alberto Estay, MD, Principal investigator, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01778829
- Sponsor's protocol ID
- Sa10i20033
- Acronym
- VNINS
- Status last verified
- Jan 2013
- First submitted
- 24 Jan 2013
- Last updated
- 29 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Estay AS, Mariani GL, Alvarez CA, Milet B, Agost D, Avila CP, Roldan L, Abdala DA, Keller R, Galletti MF, Gonzalez A; for the NEOCOSUR Neonatal Network. Randomized Controlled Trial of Nonsynchronized Nasal Intermittent Positive Pressure Ventilation versus Nasal CPAP after Extubation of VLBW Infants. Neonatology. 2020;117(2):193-199. doi: 10.1159/000506164. Epub 2020 May 8.
PubMed 32388511
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal Intermittent Mandatory Ventilation Versus Continuous Positive Airway Pressure After Extubation of Very Low Birth Weight Infants of the NEOCOSUR Network.
- ClinicalTrials.gov ID
- NCT01778829
- Acronym / sponsor ID
- VNINS / Sa10i20033
- Conditions
- Neonatal Respiratory Failure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- May 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 29 Jan 2013 (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.
The purpose of this study is to determine whether Nasal intermittent positive pressure ventilation (NIPPV) non synchronized is better than continuous positive airway pressure (NCPAP)in preventing extubation failure within 72 h, after extubation of very low birth weight infants at the NEOCOSUR Network.
Detailed description
Is a Randomized trial to preterms infants <1500g and less than 34 weeks with RDS requiring machanical ventilation in the extubation period, randomized to receive NIPPV or NCPAP once extubation criteria were met. Parental written informed consent is required previous extubation. The failure rate is defined as the need for re-intubation and mechanical ventilation).
Exclusion criteria are: major congenital anomalies; presence of cardiovascular instability;intubation less than 2 hours; mechanical ventilation more than 14 days, using muscle relaxant, airway anomalies, consent not provided or refused.
Outcome measures:
The primary outcome was to assess the need for re-intubation within the first 72 hours after extubation in the 2 groups.
The criteria for failure were met by at least 1 of the following:
pH < 7.25 and PaCO2 > 65 mmHg; recurrent apnea more than 2 episodes per hour associated with bradycardia; during 4 hour continuous; 2 episodes of apnea that required bagand-mask ventilation in any time during the study; or a PaO2 < 50 mm Hg with a fraction of inspired oxygen > 0.6. The secondary outcomes concerning respiratory support were total duration on ETT ventilation, total duration on NCPAP, total duration on supplemental oxygen, incidence of pneumothorax,BPD and dead. Other outcomes included incidence of patent ductus arteriosus (PDA), necrotizing enterocolitis, intraventricular hemorrhage grades 3 and 4, retinopathy of prematurity stage 3, time to full feeds, and length of hospital stay.
Sample size calculations for the primary outcome: We estimated that there would be a more than 80% chance of detecting 43% difference between the groups (alpha 0.05) when samplesize (n) is 110 patients for each mode of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPAP ventilation mode | Active comparator | Procedure: CPAP ventilation modeOnce the patient is extubated, CPAP ventilation mode is inmediately administered in order to prevent reintubation |
| NIPPV ventilation mode | Experimental | Procedure: NIPPV ventilation modeNIPPV: Non Invasive Ventilation mode is administered inmediately after extubation to prevent reintubation |
Who may qualify
- Ages
- 2 hours to 14 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Preterm with a weight less than 1501 g
- Gestational age less or equal to 34 weeks
- Preterm that meets extubation criteria after at least 2 hours and less than 14 days connected to mechanical ventilation
- Patient receiving methylxanthynes
Key exclusion criteria (7 listed)
- Patient more than 14 days in mechanical ventilation
- Newborn with congenital cardiopathy
- Newborn with congenital malformation
- Newborn wirh chromosomopathy or genopathic disease
- Newborn with suspected gastrointestinal disease
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 |
|---|---|---|
| CPAP ventilation modePatients are ventilated through a nasal prong coneected to a ventilator that provides a continuous positive airway pressure | Procedure or surgery | CPAP ventilation mode |
| NIPPV ventilation modePatients are ventilated through a nasal prong connected to a ventilator that provides a non synchronized intermittent positive pressure ventilation | Procedure or surgery | NIPPV ventilation mode |
Primary outcome
Extubation failure
Time frame: apnea rate and respiratory failure.
The criteria for failure were met by at least 1 of the following: pH less than 7.25 and PaCO2 over 65 mmHg; recurrent apnea more than 2 episodes per hour associated with bradycardia; during 4 hour continuous; 2 episodes of apnea that required bagand-mask ventilation in any time during the study; or a PaO2 less than 50 mm Hg with a fraction of inspired oxygen over 0.6.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2013.
- Derived from this study: PubMed 32388511Estay AS, Mariani GL, Alvarez CA, Milet B, Agost D, Avila CP, Roldan L, Abdala DA, Keller R, Galletti MF, Gonzalez A; for the NEOCOSUR Neonatal Network. Randomized Controlled Trial of Nonsynchronized Nasal Intermittent Positive Pressure Ventilation versus Nasal CPAP after Extubation of VLBW Infants. Neonatology. 2020;117(2):193-199. doi: 10.1159/000506164. Epub 2020 May 8.
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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.
Alvaro Gonzalez, MD contact
Alberto Estay, MD principal investigator
Pontificia Universidad Catolica de Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CPAP ventilation mode and NIPPV ventilation mode in people with Neonatal Respiratory Failure, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 29 Jan 2013. 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 Chile. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alberto Estay, MD (56223546437, albertoestay@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extubation failure (time frame: apnea rate and respiratory failure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01778829, which also lists 1 linked publication.
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 29 Jan 2013.