Respiratory Distress SyndromePhase 2NCT01383850
NCPAP + Heliox as a Treatment for Infant Respiratory Distress Syndrome (RDS)
A Phase 2 study testing NCPAP + standard air and NCPAP + Heliox in people with Respiratory Distress Syndrome and Bronchopulmonary Dysplasia, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial summary
Infants born between 28 and 32 weeks' gestation with radiological findings and clinical symptoms of moderate RDS, requiring respiratory support with Nasal Continuous Positive Airway Pressure (NCPAP) within the first hour of life, were randomized to receive either standard medical air or a Heliox/Oxygen mixture 80/20… Read more about this study
- Who is it for?
- Ages 28 to 32 weeks
- Conditions the study is for
- Respiratory Distress Syndrome, Bronchopulmonary Dysplasia
- What is being tested?
- NCPAP + standard air and NCPAP + Heliox
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2008to Sep 2010
- Phase
- Phase 2
- 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 28 to 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- inborn infants between 28 and 32 weeks of GA
- Silverman score > 5,
- radiological finding of RDS
- a requirement of inspiratory flow of oxygen (FiO2) > 0,25 (SaO2 ) between 88-95% within the first hour of life.
Who cannot join
- major congenital malformations
- intraventricular hemorrhage (IVH) more than grade 2
- need of intubation in the delivery room or requirement of FiO2 >0,4 during the first hour of life.
Trial locations and contacts
1 site in 1 country.
Italy1 site
NICU, Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico, Università degli Studi di Milano
Milan, 20122
About this study
Infants born between 28 and 32 weeks' gestation with radiological findings and clinical symptoms of moderate RDS, requiring respiratory support with Nasal Continuous Positive Airway Pressure (NCPAP) within the first hour of life, were randomized to receive either standard medical air or a Heliox/Oxygen mixture 80/20 (Heliox) during the first 12 hours of life, followed by medical air until NCPAP was needed. The aim of the study was to assess the therapeutic effects of breathing a low-density gas mixture (heliox: 80% helium and 20% oxygen) in premature babies with Respiratory Distress Syndrome (RDS), undergoing NCPAP in terms of reducing the rate of mechanical ventilation (MV).
- Being tested
- NCPAP + standard air, NCPAP + Heliox
- Keywords
- preterm infants, nasal continuous positive airway pressure, heliox, bronchopulmonary dysplasia.
- Medical subject headings
- Respiratory Distress Syndrome, Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NCPAP + standard airOther
NCAP (SiPAP, Vyasis) was used to administer standard air
NCPAP + HelioxOther
Heliox21 (mixture of Helium 80%- Oxygen 20%) (BOC Medical UK- The Linde group) was stored in 10 liter cylinders and administrated through NCPAP for 12 hours (study period) starting from randomization.
| Study group | Role | What they receive |
|---|---|---|
| NCPAP + standard air | Active comparator | Not described Receives: Other: NCPAP + standard air; Other: NCPAP + Heliox |
| NCPAP + Heliox | Experimental | Not described Receives: Other: NCPAP + standard air; Other: NCPAP + Heliox |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy in reducing need of MV
efficacy in reducing need of intubation for MV in infantans undergoing NCPAP within the first 7 days of life
Measured: 7 days
Secondary outcomes (4)
surfactant need
number of doses of exogenous surfactant
Measured: participants will be followed for the duration of hospital stay, an expected average of 10 weeks
major complications of prematurity
incidence of major complications of prematurity
Measured: participants will be followed for the duration of hospital stay, an expected average of 10 weeks
ventilatory assistance
number of days of ventilatory assistance
Measured: participants will be followed for the duration of hospital stay, an expected average of 10 weeks
length of stay
number of days of hospital stay
Measured: participants will be followed for the duration of hospital stay, an expected 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 posted28 Jun 2011 (estimated)
- Study startFeb 2008
- Primary completionSep 2010
- Study completionSep 2010
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 Respiratory Distress SyndromeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01383850
- Sponsor's protocol ID
- Heliox
- Status last verified
- Jun 2011
- First submitted
- 9 Mar 2011
- Last updated
- 28 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Colnaghi M, Pierro M, Migliori C, Ciralli F, Matassa PG, Vendettuoli V, Mercadante D, Consonni D, Mosca F. Nasal continuous positive airway pressure with heliox in preterm infants with respiratory distress syndrome. Pediatrics. 2012 Feb;129(2):e333-8. doi: 10.1542/peds.2011-0532. Epub 2012 Jan 30.
PubMed 22291116
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NCPAP + Heliox as a Treatment for Infant Respiratory Distress Syndrome (RDS)
- ClinicalTrials.gov ID
- NCT01383850
- Acronym / sponsor ID
- Heliox
- Keywords
- preterm infants, nasal continuous positive airway pressure, heliox, bronchopulmonary dysplasia.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 28 Jun 2011 (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.
Infants born between 28 and 32 weeks' gestation with radiological findings and clinical symptoms of moderate RDS, requiring respiratory support with Nasal Continuous Positive Airway Pressure (NCPAP) within the first hour of life, were randomized to receive either standard medical air or a Heliox/Oxygen mixture 80/20 (Heliox) during the first 12 hours of life, followed by medical air until NCPAP was needed. The aim of the study was to assess the therapeutic effects of breathing a low-density gas mixture (heliox: 80% helium and 20% oxygen) in premature babies with Respiratory Distress Syndrome (RDS), undergoing NCPAP in terms of reducing the rate of mechanical ventilation (MV).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NCPAP + standard air | Active comparator | Other: NCPAP + standard air, Other: NCPAP + Heliox |
| NCPAP + Heliox | Experimental | Other: NCPAP + standard air, Other: NCPAP + Heliox |
Who may qualify
- Ages
- 28 to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- inborn infants between 28 and 32 weeks of GA
- Silverman score > 5,
- radiological finding of RDS
- a requirement of inspiratory flow of oxygen (FiO2) > 0,25 (SaO2 ) between 88-95% within the first hour of life.
Key exclusion criteria (3 listed)
- major congenital malformations
- intraventricular hemorrhage (IVH) more than grade 2
- need of intubation in the delivery room or requirement of FiO2 >0,4 during the first hour of life.
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 |
|---|---|---|
| NCPAP + standard airNCAP (SiPAP, Vyasis) was used to administer standard air | Other | NCPAP + Heliox, NCPAP + standard air |
| NCPAP + HelioxHeliox21 (mixture of Helium 80%- Oxygen 20%) (BOC Medical UK- The Linde group) was stored in 10 liter cylinders and administrated through NCPAP for 12 hours (study period) starting from randomization. | Other | NCPAP + Heliox, NCPAP + standard air |
Primary outcome
Efficacy in reducing need of MV
Time frame: 7 days
efficacy in reducing need of intubation for MV in infantans undergoing NCPAP within the first 7 days of life
4 secondary outcomes
surfactant need
Time frame: participants will be followed for the duration of hospital stay, an expected average of 10 weeks
major complications of prematurity
Time frame: participants will be followed for the duration of hospital stay, an expected average of 10 weeks
ventilatory assistance
Time frame: participants will be followed for the duration of hospital stay, an expected average of 10 weeks
length of stay
Time frame: participants will be followed for the duration of hospital stay, an expected 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 28 Jun 2011.
- Derived from this study: PubMed 22291116Colnaghi M, Pierro M, Migliori C, Ciralli F, Matassa PG, Vendettuoli V, Mercadante D, Consonni D, Mosca F. Nasal continuous positive airway pressure with heliox in preterm infants with respiratory distress syndrome. Pediatrics. 2012 Feb;129(2):e333-8. doi: 10.1542/peds.2011-0532. Epub 2012 Jan 30.
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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 Phase 2 study testing NCPAP + standard air and NCPAP + Heliox in people with Respiratory Distress Syndrome and Bronchopulmonary Dysplasia, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico 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 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: finished, as of the sponsor's last update on 28 Jun 2011. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Efficacy in reducing need of MV (time frame: 7 days). 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 NCT01383850, 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 28 Jun 2011.