Infant, Premature, DiseasesPhase 4CURDYSNCT01039285
Exogenous Surfactant in Very Preterm Neonates in Prevention of Bronchopulmonary Dysplasia
A Phase 4 study testing Curosurf and Air in people with Infant, Premature, Diseases and Respiratory Distress Syndrome, Newborn, run by Jean Michel Hascoet at 13 sites in France.
Trial summary
Advances in perinatal care have made it possible to improve the survival of the most immature neonates, but at the cost of an increase in the population at risk of developing bronchopulmonary dysplasia (BPD). Read more about this study
- Who is it for?
- Ages 12 to 16 days
- Conditions the study is for
- Infant, Premature, Diseases, Respiratory Distress Syndrome, Newborn, Bronchopulmonary Dysplasia
- What is being tested?
- Curosurf and Air
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 13 sitesFrance
- Study dates
- Dec 2009to Jun 2022
- Phase
- Phase 4
- 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 12 to 16 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- any neonate of gestational age less than 33 weeks of amenorrhea still on conventional assisted ventilation or HFOV (High Frequency Oscillatory Ventilation), after 14 ± 2 days of life
Who cannot join
- active infection (CRP > 30 mg/L) not controlled by appropriate antibiotic treatment
- use of corticosteroids in the postnatal period
- significant neurological or malformative disease
- surgical intervention < 72 hours
- refusal of parental approval
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
France13 sites
CHU Hopital Nord
Amiens, 80054
CHU
Angers, 49033
Centre Hospitalier
Arras, 62000
CHU Hopital Clemenceau
Caen, 14033
CHU hopital d'enfants
Dijon, 21079
Centre Hospitalier
Lens, 62037
CHU Hopital Jeanne de Flandre
Lille, 59037
CHU Hopital de la Croix Rousse
Lyon, 69004
APHM hopital de la conception
Marseille, 13385
CHI Andre Gregoire
Montreuil, 93105
Maternite Regionale Universitaire
Nancy, 54042
AP-HP Hopital Port Royal
Paris, 75179
CHU Hopital Gatien de Clocheville
Tours, 37044
About this study
Official title: Exogenous Surfactant in Very Preterm Neonates Presenting With Severe Respiratory Distress in Prevention of Bronchopulmonary Dysplasia
Advances in perinatal care have made it possible to improve the survival of the most immature neonates, but at the cost of an increase in the population at risk of developing bronchopulmonary dysplasia (BPD). Measures that have attempted to limit the development of BPD are not always effective, or related to major side effects. The physiopathological factors that are identified in BPD should, in theory, respond to surfactant. Therefore, the use of an exogenous surfactant in neonates presenting with pulmonary disease requiring mechanical ventilation, leading to a significant risk of BPD, should allow earlier extubation and thus promote pulmonary healing and growth.
- Conditions
- Infant, Premature, Diseases, Respiratory Distress Syndrome, Newborn, Bronchopulmonary Dysplasia
- Being tested
- Curosurf, Air
- Keywords
- Very premature infant, Surfactant, Respiratory Distress, Bronchopulmonary Dysplasia
- Medical subject headings
- Infant, Premature, Diseases, Respiratory Distress Syndrome, Newborn, Bronchopulmonary Dysplasia, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CurosurfDrug
2.5 ml/kg instilled in the trachea
AirOther
2.5ml/kg of Air will be instilled in the trachea
| Study group | Role | What they receive |
|---|---|---|
| Surfactant instillation | Experimental | 2.5 ml/kg of Surfactant will be instilled in the trachea Receives: Drug: Curosurf |
| Placebo instillation | Placebo comparator | 2.5 ml/kg of Air will be instilled in the trachea Receives: Other: Air |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of assisted ventilation
we aim to demonstrate a significant reduction in the duration of assisted ventilation in children presenting with severe respiratory distress at 14+/-2 days of life.
Measured: days
Secondary outcomes (4)
to reduce the incidence of BPD
Measured: 36 weeks post conceptional age
to improve the inflammatory status of the lung and to restore its capacities for healing and growth
Measured: one month
to improve development in stature and weight, psychomotor development, and to reduce respiratory sequelae leading to re-hospitalisation
Measured: 2 years of age
to improve height development, psychomotor development and respiratory function
Measured: 7 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionSep 2021
- Study completionJun 2022
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 Infant, Premature, DiseasesStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jean Michel Hascoet
- Sponsor type
- University, hospital or other
- Collaborators
- ARAIRLOR, Chiesi Farmaceutici S.p.A.
- Responsible party
- Sponsor-investigator, Jean Michel Hascoet, Maternite Regionale Universitaire
- Investigators
- Jean-Michel HASCOET, MD, Study director, Maternite Regionale Universitaire NANCY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01039285
- Sponsor's protocol ID
- MRU-09-02
- Other IDs
- 2009-012817-23, 2009
- Acronym
- CURDYS
- Status last verified
- Aug 2022
- First submitted
- 23 Dec 2009
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hascoet JM, Picaud JC, Ligi I, Blanc T, Moreau F, Pinturier MF, Zupan V, Guilhoto I, Hamon IR, Alexandre C, Bouissou A, Storme L, Patkai J, Pomedio M, Rouabah M, Coletto L, Vieux R. Late Surfactant Administration in Very Preterm Neonates With Prolonged Respiratory Distress and Pulmonary Outcome at 1 Year of Age: A Randomized Clinical Trial. JAMA Pediatr. 2016 Apr;170(4):365-72. doi: 10.1001/jamapediatrics.2015.4617.
PubMed 26928567Hascoet JM, Picaud JC, Ligi I, Blanc T, Daoud P, Zupan V, Moreau F, Guilhoto I, Rouabah M, Alexandre C, Saliba E, Storme L, Patkai J, Pomedio M, Hamon I. Review shows that using surfactant a number of times or as a vehicle for budesonide may reduce the risk of bronchopulmonary dysplasia. Acta Paediatr. 2018 Jul;107(7):1140-1144. doi: 10.1111/apa.14171. Epub 2017 Dec 22.
PubMed 29193276
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exogenous Surfactant in Very Preterm Neonates Presenting With Severe Respiratory Distress in Prevention of Bronchopulmonary Dysplasia
- ClinicalTrials.gov ID
- NCT01039285
- Acronym / sponsor ID
- CURDYS / MRU-09-02
- Conditions
- Infant, Premature, Diseases, Respiratory Distress Syndrome, Newborn, Bronchopulmonary Dysplasia
- Keywords
- Very premature infant, Surfactant, Respiratory Distress, Bronchopulmonary Dysplasia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Jean Michel HascoetUniversity, hospital or other
- Collaborators
- ARAIRLOR, Chiesi Farmaceutici S.p.A.
- Study start
- Dec 2009 (actual)
- Primary completion
- Sep 2021 (actual)
- Study completion
- Jun 2022 (actual)
- First posted
- 24 Dec 2009 (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.
Advances in perinatal care have made it possible to improve the survival of the most immature neonates, but at the cost of an increase in the population at risk of developing bronchopulmonary dysplasia (BPD). Measures that have attempted to limit the development of BPD are not always effective, or related to major side effects. The physiopathological factors that are identified in BPD should, in theory, respond to surfactant. Therefore, the use of an exogenous surfactant in neonates presenting with pulmonary disease requiring mechanical ventilation, leading to a significant risk of BPD, should allow earlier extubation and thus promote pulmonary healing and growth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surfactant instillation | Experimental | Drug: Curosurf2.5 ml/kg of Surfactant will be instilled in the trachea |
| Placebo instillation | Placebo comparator | Other: Air2.5 ml/kg of Air will be instilled in the trachea |
Who may qualify
- Ages
- 12 to 16 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- any neonate of gestational age less than 33 weeks of amenorrhea still on conventional assisted ventilation or HFOV (High Frequency Oscillatory Ventilation), after 14 ± 2 days of life
Key exclusion criteria (5 listed)
- active infection (CRP > 30 mg/L) not controlled by appropriate antibiotic treatment
- use of corticosteroids in the postnatal period
- significant neurological or malformative disease
- surgical intervention < 72 hours
- refusal of parental approval
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 |
|---|---|---|
| Curosurf2.5 ml/kg instilled in the trachea | Drug | Surfactant instillation |
| Air2.5ml/kg of Air will be instilled in the trachea | Other | Placebo instillation |
Primary outcome
duration of assisted ventilation
Time frame: days
we aim to demonstrate a significant reduction in the duration of assisted ventilation in children presenting with severe respiratory distress at 14+/-2 days of life.
4 secondary outcomes
to reduce the incidence of BPD
Time frame: 36 weeks post conceptional age
to improve the inflammatory status of the lung and to restore its capacities for healing and growth
Time frame: one month
to improve development in stature and weight, psychomotor development, and to reduce respiratory sequelae leading to re-hospitalisation
Time frame: 2 years of age
to improve height development, psychomotor development and respiratory function
Time frame: 7 years of age
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 24 Aug 2022.
- Results publication: PubMed 26928567Hascoet JM, Picaud JC, Ligi I, Blanc T, Moreau F, Pinturier MF, Zupan V, Guilhoto I, Hamon IR, Alexandre C, Bouissou A, Storme L, Patkai J, Pomedio M, Rouabah M, Coletto L, Vieux R. Late Surfactant Administration in Very Preterm Neonates With Prolonged Respiratory Distress and Pulmonary Outcome at 1 Year of Age: A Randomized Clinical Trial. JAMA Pediatr. 2016 Apr;170(4):365-72. doi: 10.1001/jamapediatrics.2015.4617.
- Results publication: PubMed 29193276Hascoet JM, Picaud JC, Ligi I, Blanc T, Daoud P, Zupan V, Moreau F, Guilhoto I, Rouabah M, Alexandre C, Saliba E, Storme L, Patkai J, Pomedio M, Hamon I. Review shows that using surfactant a number of times or as a vehicle for budesonide may reduce the risk of bronchopulmonary dysplasia. Acta Paediatr. 2018 Jul;107(7):1140-1144. doi: 10.1111/apa.14171. Epub 2017 Dec 22.
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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.
Jean-Michel HASCOET, MD study director
Maternite Regionale Universitaire NANCY
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Curosurf and Air in people with Infant, Premature, Diseases and Respiratory Distress Syndrome, Newborn, run by Jean Michel Hascoet at 13 sites 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 1 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 24 Aug 2022. 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 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
duration of assisted ventilation (time frame: 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 NCT01039285, 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 24 Aug 2022.