Acute Respiratory Distress SyndromePhase 3ASPENNCT01306240
Surfactant Versus Nasal Continuous Positive Airway Pressure (nCPAP) for Respiratory Distress Syndrome in the Newborn ≥ 35 Weeks of Gestation
A Phase 3 study testing Surfactant instillation and nCPAP in people with Acute Respiratory Distress Syndrome, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Term and near term newborns can present acute respiratory distress syndrome (RDS). Surfactant treatment has been shown effective in reducing mechanical ventilation and oxygen treatment durations in the preterm newborn. Whether surfactant treatment is beneficial for term and near term newborns is unknown. Read more about this study
- Who is it for?
- Ages Up to 1 month
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- Surfactant instillation and nCPAP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2011to Oct 2012
- 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 Up to 1 month
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age between 35 and 41 weeks of gestation
- < 24 hours of life
- Nasal Continuous Positive Airways Pressure (nCPAP) for more than 1 hour
- FiO2 ≥ 30% with nCPAP and a target post-ductus arteriosus SpO2 >92%
- Written consent of the parents
Who cannot join
- FiO2 > 60% with nCPAP, ou FiO2 > 40% for 3 consecutives hours whatever the respiratory support
- Life threatening congenital pathology
- Congenital cardiopathy (except patent ductus arteriosus)
- Shock defined as systemic hypotension (mean blood pressure <10th percentile of the normal range for birth weight and postnatal age) with at least 3 of the following criteria for decrease perfusion: 1) tachycardia (heart rate > 160 beats/min); 2) abnormal peripheral pulses; 3) modified extremities coloration; 4) prolonged capillary refill time > 3 seconds; 5) urine output < 1 ml/kg/h
- Blood gas pH < 7.19 and / or PCO2 > 65 mmHg
- Apgar score ≤ 3 at 5 minutes of life
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surfactant Treatment Compared to Nasal Continuous Positive Airway Pressure for the Management of Respiratory Distress Syndrome in the Newborn Between 35 and 41 Weeks of Gestation
Term and near term newborns can present acute respiratory distress syndrome (RDS). Surfactant treatment has been shown effective in reducing mechanical ventilation and oxygen treatment durations in the preterm newborn. Whether surfactant treatment is beneficial for term and near term newborns is unknown. The purpose of this study is to compare surfactant treatment vs. nasal continuous positive airways pressure in the newborn between 35 and 41 weeks of gestation with RDS within the first 24 hours of life. The study's primary endpoint is "survival with no oxygen treatment at 72 hours of life". The secondary endpoints are: death, surfactant treatment, pneumothorax, secondary infections, pulmonary hypertension, inhaled nitric oxide treatment, fluid loading treatment, vasopressive amines treatment, mechanical ventilation duration, nCPAP treatment duration, Oxygen treatment duration, Oxygen treatment at 28 days of life, hospitalization duration and treatment strategy cost.
Read the detailed description
Newborn between 35 and 41 weeks of gestation with RDS within the first 24 hours of life, treated with nCPAP and a FiO2 ≥ 30% are eligible. Randomisation is stratified by centre and 2 age groups (35-36 weeks of gestation and 37-41 weeks ogf gestation). One arm will receive surfactant treatment after tracheal intubation. The second arm will continue nCPAP. A rescue treatment is used in the second arm if FiO2 > 60%. In each arm the newborn is weaned from mechanical ventilation and oxygen treatment as soon as possible. The primary outcome of the study is the success of the procedure defined as "survival without any oxygen treatment" at 72 hours of life.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- Surfactant instillation, nCPAP
- Keywords
- Infant newborn, Infant preterm, Acute respiratory distress syndrome, surfactant, Hyaline Membrane disease, Newborn acute respiratory distress syndrome (ARDS)
- Medical subject headings
- Respiratory Distress Syndrome, Hyaline Membrane Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surfactant instillationProcedure or surgery
Intra-tracheal poractant alpha instillation after tracheal intubation
nCPAPProcedure or surgery
Nasal Continous Positive Airways Pressure (nCPAP). Positive End Expiratory Pressure (PEEP) is set between 4 to 6 cm H2O. FiO2 is adjusted for a target post-ductus arteriosus SpO2 between 92% and 96%.
| Study group | Role | What they receive |
|---|---|---|
| Early strategy | Experimental | Intratracheal poractant alpha (Curosurf®) after tracheal intubation Receives: Procedure: Surfactant instillation |
| Delayed strategy | Active comparator | Nasal Continous Positive Airways Pressure. Intratracheal poractant alpha as a rescue treatment if FiO2 > 60% Receives: Procedure: nCPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Succes of the procedure
survival without any oxygen treatment
Measured: 72 hours of life
Secondary outcomes (1)
Morbidity associated to the management of a newborn with RDS in a neonatal intensive care unit
- Death
- Surfactant treatment,
- Pneumothorax,
- Secondary infections,
- Pulmonary hypertension,
- Inhaled nitric oxide treatment,
- Fluid loading treatment,
- Vasopressive amines treatment,
- Mechanical ventilation duration,
- nCPAP treatment duration,
- Oxygen treatment duration,
- Oxygen treatment at 28 days of life
- Hospitalization duration
- Treatment strategy cost
Measured: Every 8 hours of life between birth and 72 hours of life. Then every day until neonatal intensive care unit discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionOct 2012
- Study completionOct 2012
Why it stopped: recruiting problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01306240
- Sponsor's protocol ID
- PHRCIR09-DR-TOURNEUX
- Acronym
- ASPEN
- Status last verified
- May 2016
- First submitted
- 28 Feb 2011
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surfactant Treatment Compared to Nasal Continuous Positive Airway Pressure for the Management of Respiratory Distress Syndrome in the Newborn Between 35 and 41 Weeks of Gestation
- ClinicalTrials.gov ID
- NCT01306240
- Acronym / sponsor ID
- ASPEN / PHRCIR09-DR-TOURNEUX
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- Infant newborn, Infant preterm, Acute respiratory distress syndrome, surfactant, Hyaline Membrane disease, Newborn acute respiratory distress syndrome (ARDS)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruiting problems
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 1 Mar 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.
Term and near term newborns can present acute respiratory distress syndrome (RDS). Surfactant treatment has been shown effective in reducing mechanical ventilation and oxygen treatment durations in the preterm newborn. Whether surfactant treatment is beneficial for term and near term newborns is unknown. The purpose of this study is to compare surfactant treatment vs. nasal continuous positive airways pressure in the newborn between 35 and 41 weeks of gestation with RDS within the first 24 hours of life. The study's primary endpoint is "survival with no oxygen treatment at 72 hours of life". The secondary endpoints are: death, surfactant treatment, pneumothorax, secondary infections, pulmonary hypertension, inhaled nitric oxide treatment, fluid loading treatment, vasopressive amines treatment, mechanical ventilation duration, nCPAP treatment duration, Oxygen treatment duration, Oxygen treatment at 28 days of life, hospitalization duration and treatment strategy cost.
Detailed description
Newborn between 35 and 41 weeks of gestation with RDS within the first 24 hours of life, treated with nCPAP and a FiO2 ≥ 30% are eligible. Randomisation is stratified by centre and 2 age groups (35-36 weeks of gestation and 37-41 weeks ogf gestation). One arm will receive surfactant treatment after tracheal intubation. The second arm will continue nCPAP. A rescue treatment is used in the second arm if FiO2 > 60%. In each arm the newborn is weaned from mechanical ventilation and oxygen treatment as soon as possible. The primary outcome of the study is the success of the procedure defined as "survival without any oxygen treatment" at 72 hours of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early strategy | Experimental | Procedure: Surfactant instillationIntratracheal poractant alpha (Curosurf®) after tracheal intubation |
| Delayed strategy | Active comparator | Procedure: nCPAPNasal Continous Positive Airways Pressure. Intratracheal poractant alpha as a rescue treatment if FiO2 > 60% |
Who may qualify
- Ages
- Up to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Gestational age between 35 and 41 weeks of gestation
- < 24 hours of life
- Nasal Continuous Positive Airways Pressure (nCPAP) for more than 1 hour
- FiO2 ≥ 30% with nCPAP and a target post-ductus arteriosus SpO2 >92%
- Written consent of the parents
Key exclusion criteria (6 listed)
- FiO2 > 60% with nCPAP, ou FiO2 > 40% for 3 consecutives hours whatever the respiratory support
- Life threatening congenital pathology
- Congenital cardiopathy (except patent ductus arteriosus)
- Shock defined as systemic hypotension (mean blood pressure <10th percentile of the normal range for birth weight and postnatal age) with at least 3 of the following criteria for decrease perfusion: 1) tachycardia (heart rate > 160 beats/min); 2) abnormal peripheral pulses; 3) modified extremities coloration; 4) prolonged capillary refill time > 3 seconds; 5) urine output < 1 ml/kg/h
- Blood gas pH < 7.19 and / or PCO2 > 65 mmHg
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 |
|---|---|---|
| Surfactant instillationIntra-tracheal poractant alpha instillation after tracheal intubation | Procedure or surgery | Early strategy |
| nCPAPNasal Continous Positive Airways Pressure (nCPAP). Positive End Expiratory Pressure (PEEP) is set between 4 to 6 cm H2O. FiO2 is adjusted for a target post-ductus arteriosus SpO2 between 92% and 96%. | Procedure or surgery | Delayed strategy |
Primary outcome
Succes of the procedure
Time frame: 72 hours of life
survival without any oxygen treatment
1 secondary outcome
Morbidity associated to the management of a newborn with RDS in a neonatal intensive care unit
Time frame: Every 8 hours of life between birth and 72 hours of life. Then every day until neonatal intensive care unit discharge.
Results and safety
The study was stopped early (reason given: recruiting problems). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
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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 3 study testing Surfactant instillation and nCPAP in people with Acute Respiratory Distress Syndrome, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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 5 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: stopped early, as of the sponsor's last update on 12 May 2016. 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 France. 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?
The study was stopped early (reason given: recruiting problems). Results are not available in the source record.
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?
Succes of the procedure (time frame: 72 hours 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 12 May 2016.