Respiratory Distress SyndromePhase 3CNRNCPAPNCT00563641
Very Early Surfactant and NCPAP for Premature Infants With RDS
A Phase 3 study testing Very early surfactant and bubble NCPAP and bubble NCPAP in people with Respiratory Distress Syndrome and Pneumothorax/Pulmonary Intersticial Emphysema, run by Colombian Neonatal Research Network at 1 site in Colombia.
Trial summary
The present study will test the use of very early nasal continuous airway pressure(NCPAP)with and without surfactant in premature infants with clinical evidence or respiratory distress syndrome. Read more about this study
- Who is it for?
- Ages 27 to 31 weeks
- Conditions the study is for
- Respiratory Distress Syndrome, Pneumothorax/Pulmonary Intersticial Emphysema, Chronic Lung Disease
- What is being tested?
- Very early surfactant and bubble NCPAP and bubble NCPAP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- 1 siteColombia
- Study dates
- Jan 2004to Dec 2006
- 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 27 to 31 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age of 27 to 31 6/7 weeks,
- Postnatal age between 15 and 60 minutes,
- Supplemental oxygen requirement or evidence of increased work of breathing (tachypnea, intercostal retractions, nasal flaring, or grunting), and
- Prenatal consent.
Who cannot join
- Apgar score less than 2 at 5 minutes,
- Intubation prior to randomization,
- Prenatal diagnosis of major congenital anomalies,
- Prolonged rupture of membranes of greater than 3 weeks duration, and
- Infants who were likely to be transferred to another center soon after birth were not enrolled in the study.
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Department of Epidemiology and Biostatistics Pontificia Universidad Javeriana
Bogota, Cundinamarca
About this study
Official title: Very Early Surfactant Without Mandatory Ventilation In Premature Infants Treated With Early Continuous Positive Airway Pressure-A Randomized Controlled Trial
The present study will test the use of very early nasal continuous airway pressure(NCPAP)with and without surfactant in premature infants with clinical evidence or respiratory distress syndrome. We hypothesize that premature infants exposed to very early NCPAP and surfactant will require less mechanical ventilation compared to those premature infants exposed to NCPAP alone.
Read the detailed description
Premature infants who are not intubated during the first 15 minutes of life and who develop clinical evidence of respiratory distress or need for oxygen requirement between 15 and 60 minutes of life, will be placed on bubble NCPAP of 6 cm H2O. Randomization envelops will them be opened and patients will be assigned to continuation on NCPAP alone (Control Group) or to NCPAP plus very early surfactant therapy (Treatment Group). Patients assigned to the treatment group will be transiently intubated for surfactant administration, extubated, and placed back on NCPAP of 6 cm H2O. Both groups will then be followed over time to determine which infants meet treatment failure criteria defined as: Treatment failure was defined a priori by either failure of adequate oxygenation or ventilation as follows: "1" FiO2 greater than 0.75 for more than 30 minutes to maintain SpO2 within the pre-established target ranges, "2" persistent or recurrent desaturation below 80% that did not respond to suctioning of the airways and PPV, "3" PCO2>65 mmHg and pH<7.22 on an arterial or capillary blood gas analysis, in association with increased work of breathing. Infants in the Treatment Group who cannot be extubated after their initial dose of surfactant because of clinical instability will be analyzed as treatment failures. Premature infants that meet treatment failure criteria on either arm will be intubated and placed on mechanical ventilation and given surfactant rescue doses according to the criteria of the participating institutions. Premature infants with respiratory distress syndrome who do not meet treatment failure criteria in both groups will remain on NCPAP until their respiratory failure improves.
- Conditions
- Respiratory Distress Syndrome, Pneumothorax/Pulmonary Intersticial Emphysema, Chronic Lung Disease
- Being tested
- Very early surfactant and bubble NCPAP, bubble NCPAP
- Keywords
- NCPAP, Very early surfactant
- Medical subject headings
- Respiratory Distress Syndrome, Pneumothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Very early surfactant and bubble NCPAPOther
For patients randomized to early NCPAP plus surfactant, 4ml/kg of surfactant were administered through an endotracheal tube in two aliquots, 2 minutes apart followed by positive pressure ventilation administered for one minute with a Neopuff Infant Resuscitator pre-set to give a peak pressure of 20 cm H2O and 5 cm H2O of positive end expiratory pressure. Infant was then extubated and placed on NCPAP of 6 cmH2O
bubble NCPAPOther
Premature infants randomized to bubble NCPAP alone will continue on NCPAP until they reach "yes or no" treatment failure criteria.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Early NCPAP plus very early surfactant Receives: Other: Very early surfactant and bubble NCPAP |
| 2 | Active comparator | NCPAP alone Receives: Other: bubble NCPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for mechanical ventilation
Measured: Death or discharge from the NICU
Secondary outcomes (3)
Neonatal mortality
Measured: During hospitalization in the NICU
Air leak syndrome
Measured: death or discharge from the NICU
Oxygen dependency at 36 weeks post menstrual age
Measured: Death or discharge from the NICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2007 (estimated)
- Study startJan 2004
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress SyndromeStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colombian Neonatal Research Network
- Sponsor type
- University, hospital or other
- Collaborators
- Pontificia Universidad Javeriana, Vanderbilt University School of Medicine, Abbott, Fisher and Paykel Healthcare
- Investigators
- Mario A Rojas, MD, MPH, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00563641
- Sponsor's protocol ID
- ColombianCNRNCPAP trial
- Other IDs
- Abbott Laboratories Grant
- Acronym
- CNRNCPAP
- Status last verified
- Nov 2007
- First submitted
- 23 Nov 2007
- Last updated
- 26 Nov 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rojas MA, Lozano JM, Rojas MX; Colombian Neonatal Research Network. International collaborative research: a Colombian model that promotes infant health and research capacity. J Perinatol. 2007 Dec;27(12):738-43. doi: 10.1038/sj.jp.7211827. Epub 2007 Sep 20.
PubMed 17882265Rojas MA, Lozano JM, Rojas MX, Laughon M, Bose CL, Rondon MA, Charry L, Bastidas JA, Perez LA, Rojas C, Ovalle O, Celis LA, Garcia-Harker J, Jaramillo ML; Colombian Neonatal Research Network. Very early surfactant without mandatory ventilation in premature infants treated with early continuous positive airway pressure: a randomized, controlled trial. Pediatrics. 2009 Jan;123(1):137-42. doi: 10.1542/peds.2007-3501.
PubMed 19117872
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Very Early Surfactant Without Mandatory Ventilation In Premature Infants Treated With Early Continuous Positive Airway Pressure-A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00563641
- Acronym / sponsor ID
- CNRNCPAP / ColombianCNRNCPAP trial
- Conditions
- Respiratory Distress Syndrome, Pneumothorax/Pulmonary Intersticial Emphysema, Chronic Lung Disease
- Keywords
- NCPAP, Very early surfactant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- Colombian Neonatal Research NetworkUniversity, hospital or other
- Collaborators
- Pontificia Universidad Javeriana, Vanderbilt University School of Medicine, Abbott, Fisher and Paykel Healthcare
- Study start
- Jan 2004
- Study completion
- Dec 2006 (actual)
- First posted
- 26 Nov 2007 (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 present study will test the use of very early nasal continuous airway pressure(NCPAP)with and without surfactant in premature infants with clinical evidence or respiratory distress syndrome. We hypothesize that premature infants exposed to very early NCPAP and surfactant will require less mechanical ventilation compared to those premature infants exposed to NCPAP alone.
Detailed description
Premature infants who are not intubated during the first 15 minutes of life and who develop clinical evidence of respiratory distress or need for oxygen requirement between 15 and 60 minutes of life, will be placed on bubble NCPAP of 6 cm H2O. Randomization envelops will them be opened and patients will be assigned to continuation on NCPAP alone (Control Group) or to NCPAP plus very early surfactant therapy (Treatment Group). Patients assigned to the treatment group will be transiently intubated for surfactant administration, extubated, and placed back on NCPAP of 6 cm H2O. Both groups will then be followed over time to determine which infants meet treatment failure criteria defined as: Treatment failure was defined a priori by either failure of adequate oxygenation or ventilation as follows: "1" FiO2 greater than 0.75 for more than 30 minutes to maintain SpO2 within the pre-established target ranges, "2" persistent or recurrent desaturation below 80% that did not respond to suctioning of the airways and PPV, "3" PCO2>65 mmHg and pH<7.22 on an arterial or capillary blood gas analysis, in association with increased work of breathing. Infants in the Treatment Group who cannot be extubated after their initial dose of surfactant because of clinical instability will be analyzed as treatment failures. Premature infants that meet treatment failure criteria on either arm will be intubated and placed on mechanical ventilation and given surfactant rescue doses according to the criteria of the participating institutions. Premature infants with respiratory distress syndrome who do not meet treatment failure criteria in both groups will remain on NCPAP until their respiratory failure improves.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Very early surfactant and bubble NCPAPEarly NCPAP plus very early surfactant |
| 2 | Active comparator | Other: bubble NCPAPNCPAP alone |
Who may qualify
- Ages
- 27 to 31 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Gestational age of 27 to 31 6/7 weeks,
- Postnatal age between 15 and 60 minutes,
- Supplemental oxygen requirement or evidence of increased work of breathing (tachypnea, intercostal retractions, nasal flaring, or grunting), and
- Prenatal consent.
Key exclusion criteria (5 listed)
- Apgar score less than 2 at 5 minutes,
- Intubation prior to randomization,
- Prenatal diagnosis of major congenital anomalies,
- Prolonged rupture of membranes of greater than 3 weeks duration, and
- Infants who were likely to be transferred to another center soon after birth were not enrolled in the study.
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 |
|---|---|---|
| Very early surfactant and bubble NCPAPFor patients randomized to early NCPAP plus surfactant, 4ml/kg of surfactant were administered through an endotracheal tube in two aliquots, 2 minutes apart followed by positive pressure ventilation administered for one minute with a Neopuff Infant Resuscitator pre-set to give a peak pressure of 20 cm H2O and 5 cm H2O of positive end expiratory pressure. Infant was then extubated and placed on NCPAP of 6 cmH2O | Other | 1 |
| bubble NCPAPPremature infants randomized to bubble NCPAP alone will continue on NCPAP until they reach "yes or no" treatment failure criteria. | Other | 2 |
Primary outcome
Need for mechanical ventilation
Time frame: Death or discharge from the NICU
3 secondary outcomes
Neonatal mortality
Time frame: During hospitalization in the NICU
Air leak syndrome
Time frame: death or discharge from the NICU
Oxygen dependency at 36 weeks post menstrual age
Time frame: Death or discharge from the NICU
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 26 Nov 2007.
- Background: PubMed 17882265Rojas MA, Lozano JM, Rojas MX; Colombian Neonatal Research Network. International collaborative research: a Colombian model that promotes infant health and research capacity. J Perinatol. 2007 Dec;27(12):738-43. doi: 10.1038/sj.jp.7211827. Epub 2007 Sep 20.
- Derived from this study: PubMed 19117872Rojas MA, Lozano JM, Rojas MX, Laughon M, Bose CL, Rondon MA, Charry L, Bastidas JA, Perez LA, Rojas C, Ovalle O, Celis LA, Garcia-Harker J, Jaramillo ML; Colombian Neonatal Research Network. Very early surfactant without mandatory ventilation in premature infants treated with early continuous positive airway pressure: a randomized, controlled trial. Pediatrics. 2009 Jan;123(1):137-42. doi: 10.1542/peds.2007-3501.
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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.
Mario A Rojas, MD, MPH principal investigator
Vanderbilt University
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 Very early surfactant and bubble NCPAP and bubble NCPAP in people with Respiratory Distress Syndrome and Pneumothorax/Pulmonary Intersticial Emphysema, run by Colombian Neonatal Research Network at 1 site in Colombia.
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 5 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 26 Nov 2007. 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 Colombia. 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 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?
Need for mechanical ventilation (time frame: Death or discharge from the NICU). 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 NCT00563641, which also lists 2 linked publications.
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 26 Nov 2007.