Respiratory Distress Syndrome, NewbornNIPALNCT05796128
NIPPV vs.nCPAP During LISA Procedure
A study testing Nasal Intermittent Positive Pressure Ventilation (NIPPV) and Nasal continuous positive airway pressure (NCPAP) in people with Respiratory Distress Syndrome, Newborn, run by University of Florence at 1 site in Italy.
Trial summary
The goal of this randomized controlled study is to compare the efficacy of using NIPPV versus NCPAP during the LISA procedure in very preterm infants. The main question it aims to answer is: Does NIPPV during the LISA procedure decrease the need for a second dose of surfactant or the need of mechanical ventilation… Read more about this study
- Who is it for?
- Ages 0 to 72 hours
- Conditions the study is for
- Respiratory Distress Syndrome, Newborn
- What is being tested?
- Nasal Intermittent Positive Pressure Ventilation (NIPPV) and Nasal continuous positive airway pressure (NCPAP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2020to 23 Jan 2023
- 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 0 to 72 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- -Infants with gestational age between 25+0 and 31+6 gestational weeks,
- -RDS which does not require MV
- -Treatment with NCPAP and FiO2 >0.30 within the first 6 hours of life,
- -First dose of caffeine administered
Who cannot join
- -absence of informed consent,
- -major congenital malformations,
- -hydrops fetalis,
- -chromosomal diseases,
- -previous treatment with surfactant,
- -cardiorespiratory instability requiring treatment with vasoactive drugs,
- -pneumothorax,
- -death within 72 hours of life.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Careggi University Hospital, Division of Neonatology
Florence, 50141
About this study
Official title: Nasal Intermittent Positive Pressure Ventilation Versus Nasal Continuous Positive Airway Pressure Durante la Somministrazione Del Surfattante Con Tecnica LISA
The goal of this randomized controlled study is to compare the efficacy of using NIPPV versus NCPAP during the LISA procedure in very preterm infants.
The main question it aims to answer is:
- Does NIPPV during the LISA procedure decrease the need for a second dose of surfactant or the need of mechanical ventilation during the first 72 hours of life in comparison with NCPAP? Infants with gestational age between 25+0 and 31+6 weeks of gestation with RDS who do not require VM and treated with NCPAP and FiO2 >0.30 within the first 6 hours of life who received the first dose of caffeine will be eligible for enrollment in the study Participants will be randomized to receive surfactant with conventional LISA procedure, i.e. performed during NCPAP, or with LISA procedure performed during NIPPV.
- Conditions
- Respiratory Distress Syndrome, Newborn
- Being tested
- Nasal Intermittent Positive Pressure Ventilation (NIPPV), Nasal continuous positive airway pressure (NCPAP)
- Keywords
- Surfactant, LISA procedure, Preterm infant
- Medical subject headings
- Respiratory Distress Syndrome, Newborn, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal Intermittent Positive Pressure Ventilation (NIPPV)Procedure or surgery
In this group, infants will receive NIPPV during LISA procedure.
Nasal continuous positive airway pressure (NCPAP)Procedure or surgery
In this group, infants will receive NCPAP during LISA procedure.
| Study group | Role | What they receive |
|---|---|---|
| LISA with NCPAP | Active comparator | In this group, infants will receive NCPAP during LISA procedure. Receives: Procedure: Nasal continuous positive airway pressure (NCPAP) |
| LISA with NIPPV | Experimental | In this group, infants will receive NIPPV during LISA procedure. Receives: Procedure: Nasal Intermittent Positive Pressure Ventilation (NIPPV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surfactant or mechanical ventilation
Need for a second dose of surfactant or mechanical ventilation
Measured: The need for a second dose of surfactant or mechanical ventilation will be evaluated within the first 72 hour of life
Secondary outcomes (3)
Noninvasive ventilation
Duration of noninvasive ventilation
Measured: Participants will be monitored for the duration of their hospital stay, which is an average of 10 weeks
Mechanical ventilation
Duration ofmechanical ventilation
Measured: Participants will be monitored for the duration of their hospital stay, which is an average of 10 weeks
Bronchopulmonary dysplasia
Frequency of mild, moderate, and severe bronchopulmonary dysplasia
Measured: Participants will be monitored for the duration of their hospital stay, which is an average of 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start1 Oct 2020
- Primary completion31 Oct 2022
- Study completion23 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress Syndrome, NewbornStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florence
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlo Dani, University of Florence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05796128
- Sponsor's protocol ID
- NIPAL02
- Acronym
- NIPAL
- Status last verified
- Mar 2023
- First submitted
- 8 Mar 2023
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal Intermittent Positive Pressure Ventilation Versus Nasal Continuous Positive Airway Pressure Durante la Somministrazione Del Surfattante Con Tecnica LISA
- ClinicalTrials.gov ID
- NCT05796128
- Acronym / sponsor ID
- NIPAL / NIPAL02
- Conditions
- Respiratory Distress Syndrome, Newborn
- Keywords
- Surfactant, LISA procedure, Preterm infant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- University of FlorenceUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 23 Jan 2023 (actual)
- First posted
- 3 Apr 2023 (actual)
- 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 goal of this randomized controlled study is to compare the efficacy of using NIPPV versus NCPAP during the LISA procedure in very preterm infants.
The main question it aims to answer is:
- Does NIPPV during the LISA procedure decrease the need for a second dose of surfactant or the need of mechanical ventilation during the first 72 hours of life in comparison with NCPAP? Infants with gestational age between 25+0 and 31+6 weeks of gestation with RDS who do not require VM and treated with NCPAP and FiO2 >0.30 within the first 6 hours of life who received the first dose of caffeine will be eligible for enrollment in the study Participants will be randomized to receive surfactant with conventional LISA procedure, i.e. performed during NCPAP, or with LISA procedure performed during NIPPV.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LISA with NCPAP | Active comparator | Procedure: Nasal continuous positive airway pressure (NCPAP)In this group, infants will receive NCPAP during LISA procedure. |
| LISA with NIPPV | Experimental | Procedure: Nasal Intermittent Positive Pressure Ventilation (NIPPV)In this group, infants will receive NIPPV during LISA procedure. |
Who may qualify
- Ages
- 0 to 72 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- -Infants with gestational age between 25+0 and 31+6 gestational weeks,
- -RDS which does not require MV
- -Treatment with NCPAP and FiO2 >0.30 within the first 6 hours of life,
- -First dose of caffeine administered
Key exclusion criteria (8 listed)
- -absence of informed consent,
- -major congenital malformations,
- -hydrops fetalis,
- -chromosomal diseases,
- -previous treatment with surfactant,
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 |
|---|---|---|
| Nasal Intermittent Positive Pressure Ventilation (NIPPV)In this group, infants will receive NIPPV during LISA procedure. | Procedure or surgery | LISA with NIPPV |
| Nasal continuous positive airway pressure (NCPAP)In this group, infants will receive NCPAP during LISA procedure. | Procedure or surgery | LISA with NCPAP |
Primary outcome
Surfactant or mechanical ventilation
Time frame: The need for a second dose of surfactant or mechanical ventilation will be evaluated within the first 72 hour of life
Need for a second dose of surfactant or mechanical ventilation
3 secondary outcomes
Noninvasive ventilation
Time frame: Participants will be monitored for the duration of their hospital stay, which is an average of 10 weeks
Mechanical ventilation
Time frame: Participants will be monitored for the duration of their hospital stay, which is an average of 10 weeks
Bronchopulmonary dysplasia
Time frame: Participants will be monitored for the duration of their hospital stay, which is an average of 10 weeks
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 3 Apr 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal Intermittent Positive Pressure Ventilation (NIPPV) and Nasal continuous positive airway pressure (NCPAP) in people with Respiratory Distress Syndrome, Newborn, run by University of Florence at 1 site in Italy.
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 8 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 3 Apr 2023. 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 Italy. 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?
Surfactant or mechanical ventilation (time frame: The need for a second dose of surfactant or mechanical ventilation will be evaluated within the first 72 hour 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 3 Apr 2023.