Preterm InfantVAPORAMNCT03853161
High Flow Nasal Cannula Versus Nasal Intermittent Positive Pressure (NIPPV) in Preterm Infants
A study testing Vapotherm and NIPPV in people with Preterm Infant, run by Carmel Medical Center at 1 site in Israel.
Trial summary
The aim of this study is to compare the effectiveness of Heated Humidified High Flow Nasal Cannula (HHHFNC) versus Nasal Intermittent Positive Pressure Ventilation (NIPPV) in preventing intubation when used as primary respiratory support for Respiratory Distress Syndrome (RDS) or post extubation in preterm infants Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Preterm Infant
- What is being tested?
- Vapotherm and NIPPV
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteIsrael
- Study dates
- 21 Jan 2018to 1 Jul 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Infants born at 24-27+6 weeks of gestation and up to 28 days of life who are extubated for the first time after birth or immediately after surfactant administration via (intubation-surfactant-extubation) INSURE or (minimally invasive surfactant therapy) MIST procedures.
- Infants born at 28-36+6 weeks of gestation and up to 28 days of life who are candidates for non-invasive support either as a primary modality after birth or post extubation.
- Signed parental informed consent by one of the parents
Who cannot join
- Infants who are unlikely to survive the immediate postnatal period or who have significant congenital abnormalities
- Presence of a pneumothorax prior to enrollment
- Hemodynamic instability due to sepsis or hemorrhage
- Inability to obtain parental consent
- Shortage of suitable equipment
- Infants who were intubated solely for surgery
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Carmel Medical Center
Haifa
Ayala Gover, MD, 972-52-396948, ayalagover@gmail.com
About this study
Official title: A Multicenter Randomized Controlled Trial Comparing High Flow Nasal Cannula and NIPPV in Preterm Infants
The aim of this study is to compare the effectiveness of Heated Humidified High Flow Nasal Cannula (HHHFNC) versus Nasal Intermittent Positive Pressure Ventilation (NIPPV) in preventing intubation when used as primary respiratory support for Respiratory Distress Syndrome (RDS) or post extubation in preterm infants
Read the detailed description
Patient population will include preterm infants born at 24 - 36+6 weeks of gestation who are candidates for non-invasive respiratory support post extubation or as primary respiratory support after birth. They will be will be randomized to 2 groups: Heated Humidified High Flow Nasal Cannula (HHHFNC) and Nasal Intermittent Positive Pressure Ventilation (NIPPV).
This will be a prospective unblinded randomized controlled study, designed as a non-inferiority trial.
Primary outcome: The primary outcome will be rate of treatment failure (need for intubation) within 7 days of starting the study treatment
- Conditions
- Preterm Infant
- Being tested
- Vapotherm, NIPPV
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VapothermOther
Also called Heated Humidified High Flow Nasal Cannula
A form of non invasive ventilation used in newborns
NIPPVOther
Also called Nasal Intermittent Positive Pressure Ventilation
A form of non invasive ventilation used in newborns
| Study group | Role | What they receive |
|---|---|---|
| Vapotherm arm | Experimental | Preterm infants in this arm will be given respiratory support of heated humidified high flow via Precision Flow Vapotherm, Exeter, USA Receives: Other: Vapotherm |
| NIPPV arm | Experimental | Preterm infants in this arm will be given respiratory support of Nasal Intermittent Positive Pressure Ventilation via the Leoni Plus neonatal ventilator Receives: Other: NIPPV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of intubation within 7 days of starting the study treatment
Failure of non invasive support by criteria of pH, blood carbon dioxide level, oxygen requirements or apneas
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2019
- Study start21 Jan 2018
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm InfantStudies 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
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayala Gover, Carmel Medical Center
- Investigators
- Ayala Gover, MD, Principal investigator, Carmel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03853161
- Sponsor's protocol ID
- CMC-17-0131-CTIL
- Acronym
- VAPORAM
- Status last verified
- Feb 2021
- First submitted
- 19 Feb 2019
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Controlled Trial Comparing High Flow Nasal Cannula and NIPPV in Preterm Infants
- ClinicalTrials.gov ID
- NCT03853161
- Acronym / sponsor ID
- VAPORAM / CMC-17-0131-CTIL
- Conditions
- Preterm Infant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Study start
- 21 Jan 2018 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 25 Feb 2019 (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 aim of this study is to compare the effectiveness of Heated Humidified High Flow Nasal Cannula (HHHFNC) versus Nasal Intermittent Positive Pressure Ventilation (NIPPV) in preventing intubation when used as primary respiratory support for Respiratory Distress Syndrome (RDS) or post extubation in preterm infants
Detailed description
Patient population will include preterm infants born at 24 - 36+6 weeks of gestation who are candidates for non-invasive respiratory support post extubation or as primary respiratory support after birth. They will be will be randomized to 2 groups: Heated Humidified High Flow Nasal Cannula (HHHFNC) and Nasal Intermittent Positive Pressure Ventilation (NIPPV).
This will be a prospective unblinded randomized controlled study, designed as a non-inferiority trial.
Primary outcome: The primary outcome will be rate of treatment failure (need for intubation) within 7 days of starting the study treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vapotherm arm | Experimental | Other: VapothermPreterm infants in this arm will be given respiratory support of heated humidified high flow via Precision Flow Vapotherm, Exeter, USA |
| NIPPV arm | Experimental | Other: NIPPVPreterm infants in this arm will be given respiratory support of Nasal Intermittent Positive Pressure Ventilation via the Leoni Plus neonatal ventilator |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Infants born at 24-27+6 weeks of gestation and up to 28 days of life who are extubated for the first time after birth or immediately after surfactant administration via (intubation-surfactant-extubation) INSURE or (minimally invasive surfactant therapy) MIST procedures.
- Infants born at 28-36+6 weeks of gestation and up to 28 days of life who are candidates for non-invasive support either as a primary modality after birth or post extubation.
- Signed parental informed consent by one of the parents
Key exclusion criteria (6 listed)
- Infants who are unlikely to survive the immediate postnatal period or who have significant congenital abnormalities
- Presence of a pneumothorax prior to enrollment
- Hemodynamic instability due to sepsis or hemorrhage
- Inability to obtain parental consent
- Shortage of suitable equipment
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 |
|---|---|---|
| VapothermAlso: Heated Humidified High Flow Nasal CannulaA form of non invasive ventilation used in newborns | Other | Vapotherm arm |
| NIPPVAlso: Nasal Intermittent Positive Pressure VentilationA form of non invasive ventilation used in newborns | Other | NIPPV arm |
Primary outcome
Rate of intubation within 7 days of starting the study treatment
Time frame: one week
Failure of non invasive support by criteria of pH, blood carbon dioxide level, oxygen requirements or apneas
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Individual participant dataSharing planned: No
Related trials for Preterm Infant
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Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
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Growing Little PEAPODS Study
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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.
Ayala Gover, MD principal investigator
Carmel Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vapotherm and NIPPV in people with Preterm Infant, run by Carmel Medical Center at 1 site in Israel.
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 3 inclusion and 6 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 9 Feb 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayala Gover, MD (972-528-396948, ayalagover@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of intubation within 7 days of starting the study treatment (time frame: one week). 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 9 Feb 2021.