Respiratory Distress Syndrome, NewbornNINSAPPNCT00751959
Surfactant Application During Spontaneous Breathing With Continuous Positive Airway Pressure (CPAP) in Premature Infants < 27 Weeks
A study testing Curosurf in people with Respiratory Distress Syndrome, Newborn, run by University of Cologne at 13 sites in Germany.
Trial summary
This study investigates the efficacy of surfactant application during spontaneous breathing with CPAP in avoiding death and chronic lung disease (CLD) in very immature infants with a gestational age of less than 27 weeks. Read more about this study
- Who is it for?
- Ages 23 to 26 weeks
- Conditions the study is for
- Respiratory Distress Syndrome, Newborn
- What is being tested?
- Curosurf
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- 13 sitesGermany
- Study dates
- Apr 2009to Jun 2012
- 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 23 to 26 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- IRDS with Silverman-Score ≥ 5 and / or FiO2 ≥ 0,3
- Postnatal age of more than 10 min. and less than 2 hours
- Gestational age ≥ 23+0 and < 27+0
Who cannot join
- Primary cardio- pulmonary resuscitation
- Prenatally diagnosed severe malformation
- No parental consent
- Participation in another interventional trial
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Germany13 sites
Klinikum Aschaffenburg, Klinik für Kinder- und Jugendmedizin
Aschaffenburg, D-63739
Charité
Berlin, D-13353
Ruhr University of Bochum, Children's Hospital St. Josef Spital
Bochum, D-44791
University Hospital, Dept. of Neonatology
Bonn, D-53113
Kliniken der Stadt Koeln, Kinderkrankenhaus Riehl
Cologne, 50735
University of Cologne, Clinic for Paediatrics
Cologne, D-50937
Vestische Kinder- und Jugendklinik
Datteln, D-45711
University Hospital, Clinic for Paediatrics
Düsseldorf, D-40225
Asklepios Klinik Barmbek
Hamburg, D-22291
Hospital of Leverkusen, Dept. of Children's Medicine
Leverkusen, D-51375
University Hospital of Schleswig-Holstein, Campus Lübeck, Dept. of Children's Medicine
Lübeck, D-23538
DRK Kinderklinik
Siegen, D-57072
Klinikum Stuttgart, Olgahospital
Stuttgart, D-70196
About this study
Official title: Surfactant Application During Spontaneous Breathing With CPAP or During Mechanical Ventilation in the Therapy of IRDS in Premature Infants < 27 Weeks
This study investigates the efficacy of surfactant application during spontaneous breathing with CPAP in avoiding death and chronic lung disease (CLD) in very immature infants with a gestational age of less than 27 weeks.
Read the detailed description
80 % of extremely preterm infants with a gestational age of less than 27 completed weeks suffer from severe idiopathic respiratory distress syndrome (IRDS). They are still at high risk of mortality and long term morbidity especially of the lung and the brain. At least death and chronic lung disease (CLD) are related to the need and the duration of mechanical ventilation. Continuous positive airway pressure (CPAP) has been shown to be effective to avoid mechanical ventilation in the treatment of IRDS but it often fails in the most immature infants. Early or prophylactic surfactant application is effective in the treatment of IRDS and is the only causal therapy, but it is usually related to intubation and mechanical ventilation that should be avoided.Therefore to overcome the dilemma between need for mechanical ventilation with surfactant administration on the one hand and surfactant withholding with the use of CPAP on the other hand, a strategy was developed to administer surfactant during spontaneous breathing with CPAP (1). In the proposed prospective randomised controlled trial this strategy shall be compared with the recent gold standard in the therapy of extremely preterm infants with IRDS, that is intubation, mechanical ventilation and surfactant administration. Based on the results of a feasibility (1) study and some clinical observations it is hypothesised that the new approach is superior in avoidance of death and chronic lung disease compared to the recent gold standard.
- Conditions
- Respiratory Distress Syndrome, Newborn
- Being tested
- Curosurf
- Keywords
- Continuous positive airway pressure (CPAP), extremely preterm infant, Idiopathic respiratory distress syndrome (IRDS), Surfactant
- Medical subject headings
- Respiratory Distress Syndrome, Newborn, Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CurosurfDrug
Surfactant application via a thin endotracheal catheter during spontaneous breathing with CPAP, followed by respiratory support with CPAP
CurosurfDrug
Conventional therapy with intubation, initiation of mechanical ventilation and surfactant application
| Study group | Role | What they receive |
|---|---|---|
| 2 | Active comparator | Conventional therapy with intubation, initiation of mechanical ventilation and surfactant application Receives: Drug: Curosurf |
| 1 | Experimental | Surfactant application via a thin endotracheal catheter during spontaneous breathing with CPAP, followed by respiratory support with CPAP Receives: Drug: Curosurf |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival until term without CLD
Measured: 13-17 weeks after birth
Secondary outcomes (1)
Survival until term without CLD, IVH>II°, cystic PVL, ROP with need for surgery
Measured: 13-17 weeks after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2008 (estimated)
- Study startApr 2009
- Primary completionJun 2012
- Study completionJun 2012
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
- None (open label)
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Collaborators
- University Hopsital Schleswig Holstein Campus Lübeck, Altona Children's Hospital, Ruhr University of Bochum, Vestische Kinder- und Jugendklinik Datteln, Hospital of Leverkusen, Kliniken der Stadt Koeln, Kinderkrankenhaus Riehl, Heinrich-Heine University, Duesseldorf, Klinikum Aschaffenburg-Alzenau, Asklepios Kliniken Hamburg GmbH, Klinikum Stuttgart, DRK Kinderklinik Siegen, University Hospital, Bonn, Charite University, Berlin, Germany, The Clinical Trials Centre Cologne, German Federal Ministry of Education and Research
- Responsible party
- Principal investigator, Angela Kribs, University of Cologne
- Investigators
- Angela Kribs, MD, Principal investigator, University of Cologne, Clinic for Paediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00751959
- Sponsor's protocol ID
- Uni-Koeln-439
- Other IDs
- ISRCTN64011614
- Acronym
- NINSAPP
- Status last verified
- Jul 2012
- First submitted
- 11 Sep 2008
- Last updated
- 19 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surfactant Application During Spontaneous Breathing With CPAP or During Mechanical Ventilation in the Therapy of IRDS in Premature Infants < 27 Weeks
- ClinicalTrials.gov ID
- NCT00751959
- Acronym / sponsor ID
- NINSAPP / Uni-Koeln-439
- Conditions
- Respiratory Distress Syndrome, Newborn
- Keywords
- Continuous positive airway pressure (CPAP), extremely preterm infant, Idiopathic respiratory distress syndrome (IRDS), Surfactant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Collaborators
- University Hopsital Schleswig Holstein Campus Lübeck, Altona Children's Hospital, Ruhr University of Bochum, Vestische Kinder- und Jugendklinik Datteln, Hospital of Leverkusen, Kliniken der Stadt Koeln, Kinderkrankenhaus Riehl, Heinrich-Heine University, Duesseldorf, Klinikum Aschaffenburg-Alzenau, Asklepios Kliniken Hamburg GmbH, Klinikum Stuttgart, DRK Kinderklinik Siegen, University Hospital, Bonn, Charite University, Berlin, Germany, The Clinical Trials Centre Cologne, German Federal Ministry of Education and Research
- Study start
- Apr 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 12 Sep 2008 (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.
This study investigates the efficacy of surfactant application during spontaneous breathing with CPAP in avoiding death and chronic lung disease (CLD) in very immature infants with a gestational age of less than 27 weeks.
Detailed description
80 % of extremely preterm infants with a gestational age of less than 27 completed weeks suffer from severe idiopathic respiratory distress syndrome (IRDS). They are still at high risk of mortality and long term morbidity especially of the lung and the brain. At least death and chronic lung disease (CLD) are related to the need and the duration of mechanical ventilation. Continuous positive airway pressure (CPAP) has been shown to be effective to avoid mechanical ventilation in the treatment of IRDS but it often fails in the most immature infants. Early or prophylactic surfactant application is effective in the treatment of IRDS and is the only causal therapy, but it is usually related to intubation and mechanical ventilation that should be avoided.Therefore to overcome the dilemma between need for mechanical ventilation with surfactant administration on the one hand and surfactant withholding with the use of CPAP on the other hand, a strategy was developed to administer surfactant during spontaneous breathing with CPAP (1). In the proposed prospective randomised controlled trial this strategy shall be compared with the recent gold standard in the therapy of extremely preterm infants with IRDS, that is intubation, mechanical ventilation and surfactant administration. Based on the results of a feasibility (1) study and some clinical observations it is hypothesised that the new approach is superior in avoidance of death and chronic lung disease compared to the recent gold standard.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Active comparator | Drug: CurosurfConventional therapy with intubation, initiation of mechanical ventilation and surfactant application |
| 1 | Experimental | Drug: CurosurfSurfactant application via a thin endotracheal catheter during spontaneous breathing with CPAP, followed by respiratory support with CPAP |
Who may qualify
- Ages
- 23 to 26 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- IRDS with Silverman-Score ≥ 5 and / or FiO2 ≥ 0,3
- Postnatal age of more than 10 min. and less than 2 hours
- Gestational age ≥ 23+0 and < 27+0
Key exclusion criteria (4 listed)
- Primary cardio- pulmonary resuscitation
- Prenatally diagnosed severe malformation
- No parental consent
- Participation in another interventional trial
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 |
|---|---|---|
| CurosurfSurfactant application via a thin endotracheal catheter during spontaneous breathing with CPAP, followed by respiratory support with CPAP | Drug | 1 |
| CurosurfConventional therapy with intubation, initiation of mechanical ventilation and surfactant application | Drug | 2 |
Primary outcome
Survival until term without CLD
Time frame: 13-17 weeks after birth
1 secondary outcome
Survival until term without CLD, IVH>II°, cystic PVL, ROP with need for surgery
Time frame: 13-17 weeks after birth
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 19 Jul 2012.
Related trials for Respiratory Distress Syndrome, Newborn
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruitingObservational study
Development and Multicenter Validation of an Explainable System for Neonatal ARDS-Compatible Phenotyping
Acute Respiratory Distress Syndrome
RecruitingObservational study
Assessment of Blood Viscosity in ARDS (Acute Respiratory Distress Syndrome)
ARDS
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Recruiting
REspiratory MEchanics for Delivering Individualised Exogenous Surfactant
Respiratory Distress Syndrome in Premature Infant
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.
Angela Kribs, MD principal investigator
University of Cologne, Clinic for Paediatrics
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Curosurf in people with Respiratory Distress Syndrome, Newborn, run by University of Cologne at 13 sites in Germany.
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 4 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 19 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Germany. 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?
Survival until term without CLD (time frame: 13-17 weeks after birth). 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 19 Jul 2012.