Hyaline Membrane DiseasePROPOSURFNCT03721640
Evaluation of the Neonatal Autonomic Stress During Intubations Under Propofol in a Population of Premature Infants Under 33 w'GA
An observational study of Hyaline Membrane Disease and Preterm Infant, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Hyaline membrane disease is one of the leading causes of morbidity and mortality in premature newborns in industrialized countries. For 30 years, the management of the hyaline membranes disease has been transformed by intratracheal administration of exogenous surfactant (Curosurf®) at birth or in the following hours. Read more about this study
- Who is it for?
- Ages Up to 33 weeks
- Conditions the study is for
- Hyaline Membrane Disease, Preterm Infant
- What is being tested?
- electrocardiogram
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- 25 Feb 2019to 23 Aug 2022
- Phase
- Observational
- 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 33 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Preterm neonates (< 33 weeks GA) admitted to the tertiary Neonatal Intensive Care Unit of Saint-Etienne hospital requiring in the first week of life, an elective tracheal intubation for surfactant administration by INSURE or LISA methods
Who may be able to join
- breathing rate > 60 cycles/min
- Silverman scale > 3 and < 6
- FiO2 > 30% and < 60%
- collected consent from parents
Who cannot join
- Preterm neonates with Intraventricular hemorrhage grade III \& IV
- Preterm neonates with hemodynamic instability
- Preterm neonates with congenital heart disease
- Preterm neonates with severe congenital malformation
- Preterm neonates already sedated and/or under invasive mechanical ventilation
- FiO2 > 60%
Show all 9Show fewer
- Silverman scale > 6
- Use of amines for maintaining blood pressure
- Use of sedatives or analgesics during the last 24 hours (except paracetamol and ibuprofen)
Trial locations and contacts
1 site in 1 country.
About this study
Hyaline membrane disease is one of the leading causes of morbidity and mortality in premature newborns in industrialized countries. For 30 years, the management of the hyaline membranes disease has been transformed by intratracheal administration of exogenous surfactant (Curosurf®) at birth or in the following hours. In order to limit the harmful effects in terms of barotrauma of mechanical ventilation, several methods have been developed over the last decades, aiming at limiting the mechanical ventilation to the profile of non-invasive ventilation: Thus the administration of surfactant has become faster (although invasive) and if possible followed by immediate extubation following the INSURE (INtubation / SURfactant / Extubation) or LISA (Less-Invasive Surfactant Administration) procedure.
Given the fragility of the children concerned and their low weight, this invasive gesture has long been carried out without premedication. However, taking into account the pain induced and potential hemodynamic consequences of the gesture, neonatal societies now recommend the use of anesthetic before intubation, with a short duration sedative.
Read more
Propofol is a general anesthetic that combines these conditions and is widely used in pediatric anesthesia.
In that way, since 2016, the invetigators have modified the sedation protocol for intubation in our department and have recommended Propofol as first-line treatment for term and preterm newborn. A lot of study showed its hemodynamic safety in preterms. However, the investigators lack data on the autonomic stress really observed during intubation in this population. The investigators therefore propose to evaluate these physiological data in a non-randomized prospective observational study in premature infants under 33 weeks of gestational amenorrhea (GA), during a sedation protocol for intubation and surfactant administration according the INSURE or LISA technique, with standardized doses of propofol : 1mg/kg for preterm infants with a birthweight less than 1.5kg and 1.5mg/kg for higher birthweight.
- Conditions
- Hyaline Membrane Disease, Preterm Infant
- Being tested
- electrocardiogram
- Keywords
- INSURE (Intubation / surfactant / extubation), LISA (Less-invasive surfactant administration), surfactant, propofol
- Medical subject headings
- Hyaline Membrane Disease, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrocardiogramOther
Autonomic and hemodynamic evaluation with different indices (LF, heart rate, Systolic, diastolic and mean arterial blood pressure, SaO2) during a sedation protocol for intubation and surfactant administration according the INSURE or LISA technique.
| Study group | Role | What they receive |
|---|---|---|
| Preterm neonates (< 33 weeks GA) | Preterm neonates requiring in the first week of life, an elective tracheal intubation for surfactant administration by INSURE or LISA methods. Receives: Other: electrocardiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Real-time LF values (low frequency)
- represent the well-being sympathetic activity of the autonomic nervous system
- measured with electrocardiogram
Measured: during surfactant administration procedure
Secondary outcomes (4)
heart rate
- measured with electrocardiogram
Measured: during surfactant administration procedure
systolic arterial blood pressure
- measured with a blood pressure cuff
Measured: during surfactant administration procedure
diastolic arterial blood pressure
- measured with a blood pressure cuff
Measured: during surfactant administration procedure
Oxygen saturation
- measured by pulse oximetry
Measured: during surfactant administration procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2018
- Study start25 Feb 2019
- Primary completion23 Aug 2022
- Study completion23 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyaline Membrane DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hugues PATURAL, Principal investigator, CHU de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03721640
- Sponsor's protocol ID
- 18CH129
- Other IDs
- 2018-003233-14, 2018
- Acronym
- PROPOSURF
- Status last verified
- Mar 2024
- First submitted
- 25 Oct 2018
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Neonatal Autonomic Stress During Intubations Under Propofol in a Population of Premature Infants Under 33 w'GA
- ClinicalTrials.gov ID
- NCT03721640
- Acronym / sponsor ID
- PROPOSURF / 18CH129
- Conditions
- Hyaline Membrane Disease, Preterm Infant
- Keywords
- INSURE (Intubation / surfactant / extubation), LISA (Less-invasive surfactant administration), surfactant, propofol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- 23 Aug 2022 (actual)
- Study completion
- 23 Aug 2022 (actual)
- First posted
- 26 Oct 2018 (actual)
- 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.
Hyaline membrane disease is one of the leading causes of morbidity and mortality in premature newborns in industrialized countries. For 30 years, the management of the hyaline membranes disease has been transformed by intratracheal administration of exogenous surfactant (Curosurf®) at birth or in the following hours. In order to limit the harmful effects in terms of barotrauma of mechanical ventilation, several methods have been developed over the last decades, aiming at limiting the mechanical ventilation to the profile of non-invasive ventilation: Thus the administration of surfactant has become faster (although invasive) and if possible followed by immediate extubation following the INSURE (INtubation / SURfactant / Extubation) or LISA (Less-Invasive Surfactant Administration) procedure.
Given the fragility of the children concerned and their low weight, this invasive gesture has long been carried out without premedication. However, taking into account the pain induced and potential hemodynamic consequences of the gesture, neonatal societies now recommend the use of anesthetic before intubation, with a short duration sedative.
Propofol is a general anesthetic that combines these conditions and is widely used in pediatric anesthesia.
In that way, since 2016, the invetigators have modified the sedation protocol for intubation in our department and have recommended Propofol as first-line treatment for term and preterm newborn. A lot of study showed its hemodynamic safety in preterms. However, the investigators lack data on the autonomic stress really observed during intubation in this population. The investigators therefore propose to evaluate these physiological data in a non-randomized prospective observational study in premature infants under 33 weeks of gestational amenorrhea (GA), during a sedation protocol for intubation and surfactant administration according the INSURE or LISA technique, with standardized doses of propofol : 1mg/kg for preterm infants with a birthweight less than 1.5kg and 1.5mg/kg for higher birthweight.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preterm neonates (< 33 weeks GA) | – | Other: electrocardiogramPreterm neonates requiring in the first week of life, an elective tracheal intubation for surfactant administration by INSURE or LISA methods. |
Who may qualify
- Ages
- Up to 33 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm neonates (< 33 weeks GA) admitted to the tertiary Neonatal Intensive Care Unit of Saint-Etienne hospital requiring in the first week of life, an elective tracheal intubation for surfactant administration by INSURE or LISA methods
Key inclusion criteria (4 listed)
- breathing rate > 60 cycles/min
- Silverman scale > 3 and < 6
- FiO2 > 30% and < 60%
- collected consent from parents
Key exclusion criteria (9 listed)
- Preterm neonates with Intraventricular hemorrhage grade III \& IV
- Preterm neonates with hemodynamic instability
- Preterm neonates with congenital heart disease
- Preterm neonates with severe congenital malformation
- Preterm neonates already sedated and/or under invasive mechanical ventilation
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 |
|---|---|---|
| electrocardiogramAutonomic and hemodynamic evaluation with different indices (LF, heart rate, Systolic, diastolic and mean arterial blood pressure, SaO2) during a sedation protocol for intubation and surfactant administration according the INSURE or LISA technique. | Other | Preterm neonates (< 33 weeks GA) |
Primary outcome
Real-time LF values (low frequency)
Time frame: during surfactant administration procedure
* represent the well-being sympathetic activity of the autonomic nervous system * measured with electrocardiogram
4 secondary outcomes
heart rate
Time frame: during surfactant administration procedure
systolic arterial blood pressure
Time frame: during surfactant administration procedure
diastolic arterial blood pressure
Time frame: during surfactant administration procedure
Oxygen saturation
Time frame: during surfactant administration procedure
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 4 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Hyaline Membrane Disease
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Noninvasive High Frequency Oscillatory Ventilation Versus Nasal Intermittent Mandatory Ventilation for Respiratory Distress Syndrome in Preterm Neonates
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Surfactant Administration Methods in Preterm Infants With RDS: A Swedish Cohort Study
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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.
Hugues PATURAL principal investigator
CHU de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyaline Membrane Disease and Preterm Infant, run by Centre Hospitalier Universitaire de Saint Etienne 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 4 inclusion and 9 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 4 Mar 2024. 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.
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?
Real-time LF values (low frequency) (time frame: during surfactant administration procedure). 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 4 Mar 2024.