Premature NeonateANALISANCT03705468
Assessment of Ketamine and Propofol Sedation During LISA Method (Less Invasive Surfactant Administration)
An observational study of Premature Neonate, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Respiratory distress syndrome (RDS) caused by surfactant deficiency remains one of the major reasons of morbi-mortality in preterm infants and affects 85% of preterm babies born less than 32 week gestational age (wGA). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Premature Neonate
- How many people
- 71 participants
- Where
- 1 siteFrance
- Study dates
- 19 Sep 2018to 1 Dec 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Infant born below 30 wGA with RDS treated by CPAP requiring surfactant and Available IV line
Who may be able to join
- Infant born below 30 wGA with RDS treated by CPAP requiring surfactant
- Available IV line
- Admission to the NICU of Montpellier University Hospital Centre in the first 24 hours of life
Who cannot join
- maternal general anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Kétamine and Propofol Sedation During Intra Tracheal Surfactant Administration by the LISA Method (Less Invasive Surfactant Administration)
Respiratory distress syndrome (RDS) caused by surfactant deficiency remains one of the major reasons of morbi-mortality in preterm infants and affects 85% of preterm babies born less than 32 week gestational age (wGA). The strategy to manage RDS relies on the use of surfactant and non-invasive nasal ventilation, to limit tracheal mechanical ventilation. During recent years, surfactant administration through a thin catheter in spontaneously breathing preterm used in association with continuous positive airway pressure (CPAP) has emerged as a new approach for treating neonates with respiratory failure. The main objectives of Less Invasive Surfactant Administration (LISA) are to avoid endotracheal mechanical ventilation and its side effects including bronchopulmonary dysplasia. The LISA premedication procedure still under debate, because only 1 trial use analgesia or sedation during procedure. This reflects neonatologists concerns about side effects (apnea and the need for mechanical ventilation) of this premedication. This study aims to optimize sedation during LISA procedure by evaluating pain score with Ketamine or Protofol sedation, in Neonatal intensive care unit (NICU) patients with RDS.
Read the detailed description
Systematic reviews of the prospective studies performed suggest that among preterm infants, the use of LISA was associated with the lowest likelihood of the composite outcome of death or bronchopulmonary dysplasia (BPD) at 36 weeks' postmenstrual age when compared with the other ventilation strategies for preterm infants. Further studies are needed to optimize the indications and identify adequate strategies for premedication that preserve respiratory function and which limits pain and cardio-respiratory instability associated with laryngeal exposure without increasing risks of complications. According to a recent European survey, only 48% of neonatologists perform LISA with sedation. In a recent retrospective study, Dekker showed a more favorable COMFORTneo score with Propofol versus without, similar rates of intubation during LISA. Ketamine infusion has been used in several NICUs with few reported effects on respiratory function, but without publication. No prospective studies exist on LISA premedication. This study aims to optimize sedation during LISA in NICU patients with RDS. Comparing Ketamine and propofol sedation with rate of mechanical tracheal ventilation from the start of the LISA procedure up to 2 hours of life, in the NICU of Arnaud de Villeneuve University Hospital of Montpellier (France).
- Conditions
- Premature Neonate
- Keywords
- Less Invasive Surfactant Administration (LISA), Sedation, RDS treated by CPAP requiring surfactant, Sedation during intra tracheal surfactant administration by the LISA method, Available intravenous line
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ketamine sedation | Ketamine sedation | |
| Propofol sedation | Propofol sedation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of mechanical ventilation (MV) from the start of the LISA procedure up to 2 hours of life
The Investigators would like to evaluating the need for MV within the time of the LISA procedure and up to 2 hours of life among preterm babies less than 30wGA
Measured: 2 hours after LISA procedure
Secondary outcomes (6)
Cardiorespiratory parameters
Cardiorespiratory parameters before and at 5, 30 minutes after the drug injection: blood pressure
Measured: 5 and 30 minutes after the drug injection 24 and 72 hours of life and 36 week gestational age
Cardiorespiratory parameters
Cardiorespiratory parameters before and at 5, 30 minutes after the drug injection: FiO2
Measured: 5 and 30 minutes after the drug injection 24 and 72 hours of life and 36 week gestational age
Cardiorespiratory parameters
Cardiorespiratory parameters before and at 5, 30 minutes after the drug injection: heart rate
Measured: 5 and 30 minutes after the drug injection 24 and 72 hours of life and 36 week gestational age
Rate of MV from the start of the LISA procedure up to 24 and 72 hours of life and causes of failure
Rate of MV from the start of the LISA procedure up to 24 and 72 hours of life and causes of failure (apnea, need surfactant)
Measured: 5 and 30 minutes after the drug injection 24 and 72 hours of life and 36 week gestational age
To assess Neonatal morbidity at 36 wGA
Neonatal morbidity at 36 wGA
Measured: 5 and 30 minutes after the drug injection 24 and 72 hours of life and 36 week gestational age
To assess mortality at 36 wGA
Mortality at 36 wGA
Measured: 5 and 30 minutes after the drug injection 24 and 72 hours of life and 36 week gestational age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start19 Sep 2018
- Primary completion30 Oct 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature NeonateStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MILESI Christophe, PUPH, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03705468
- Sponsor's protocol ID
- RECHMPL18_0340
- Acronym
- ANALISA
- Status last verified
- Sep 2018
- First submitted
- 4 Sep 2018
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Brotelande C, Milesi C, Combes C, Durand S, Badr M, Cambonie G. Premedication with ketamine or propofol for less invasive surfactant administration (LISA): observational study in the delivery room. Eur J Pediatr. 2021 Sep;180(9):3053-3058. doi: 10.1007/s00431-021-04103-1. Epub 2021 May 6.
PubMed 33954805
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Kétamine and Propofol Sedation During Intra Tracheal Surfactant Administration by the LISA Method (Less Invasive Surfactant Administration)
- ClinicalTrials.gov ID
- NCT03705468
- Acronym / sponsor ID
- ANALISA / RECHMPL18_0340
- Conditions
- Premature Neonate
- Keywords
- Less Invasive Surfactant Administration (LISA), Sedation, RDS treated by CPAP requiring surfactant, Sedation during intra tracheal surfactant administration by the LISA method, Available intravenous line
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 19 Sep 2018 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 15 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.
Respiratory distress syndrome (RDS) caused by surfactant deficiency remains one of the major reasons of morbi-mortality in preterm infants and affects 85% of preterm babies born less than 32 week gestational age (wGA). The strategy to manage RDS relies on the use of surfactant and non-invasive nasal ventilation, to limit tracheal mechanical ventilation. During recent years, surfactant administration through a thin catheter in spontaneously breathing preterm used in association with continuous positive airway pressure (CPAP) has emerged as a new approach for treating neonates with respiratory failure. The main objectives of Less Invasive Surfactant Administration (LISA) are to avoid endotracheal mechanical ventilation and its side effects including bronchopulmonary dysplasia. The LISA premedication procedure still under debate, because only 1 trial use analgesia or sedation during procedure. This reflects neonatologists concerns about side effects (apnea and the need for mechanical ventilation) of this premedication. This study aims to optimize sedation during LISA procedure by evaluating pain score with Ketamine or Protofol sedation, in Neonatal intensive care unit (NICU) patients with RDS.
Detailed description
Systematic reviews of the prospective studies performed suggest that among preterm infants, the use of LISA was associated with the lowest likelihood of the composite outcome of death or bronchopulmonary dysplasia (BPD) at 36 weeks' postmenstrual age when compared with the other ventilation strategies for preterm infants. Further studies are needed to optimize the indications and identify adequate strategies for premedication that preserve respiratory function and which limits pain and cardio-respiratory instability associated with laryngeal exposure without increasing risks of complications. According to a recent European survey, only 48% of neonatologists perform LISA with sedation. In a recent retrospective study, Dekker showed a more favorable COMFORTneo score with Propofol versus without, similar rates of intubation during LISA. Ketamine infusion has been used in several NICUs with few reported effects on respiratory function, but without publication. No prospective studies exist on LISA premedication. This study aims to optimize sedation during LISA in NICU patients with RDS. Comparing Ketamine and propofol sedation with rate of mechanical tracheal ventilation from the start of the LISA procedure up to 2 hours of life, in the NICU of Arnaud de Villeneuve University Hospital of Montpellier (France).
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine sedation | – | –Ketamine sedation |
| Propofol sedation | – | –Propofol sedation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Infant born below 30 wGA with RDS treated by CPAP requiring surfactant and Available IV line
Key inclusion criteria (3 listed)
- Infant born below 30 wGA with RDS treated by CPAP requiring surfactant
- Available IV line
- Admission to the NICU of Montpellier University Hospital Centre in the first 24 hours of life
Key exclusion criteria (1 listed)
- maternal general anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of mechanical ventilation (MV) from the start of the LISA procedure up to 2 hours of life
Time frame: 2 hours after LISA procedure
The Investigators would like to evaluating the need for MV within the time of the LISA procedure and up to 2 hours of life among preterm babies less than 30wGA
6 secondary outcomes
Cardiorespiratory parameters
Time frame: 5 and 30 minutes after the drug injection 24 and 72 hours of life and 36 week gestational age
Cardiorespiratory parameters
Time frame: 5 and 30 minutes after the drug injection 24 and 72 hours of life and 36 week gestational age
Cardiorespiratory parameters
Time frame: 5 and 30 minutes after the drug injection 24 and 72 hours of life and 36 week gestational age
Rate of MV from the start of the LISA procedure up to 24 and 72 hours of life and causes of failure
Time frame: 5 and 30 minutes after the drug injection 24 and 72 hours of life and 36 week gestational age
To assess Neonatal morbidity at 36 wGA
Time frame: 5 and 30 minutes after the drug injection 24 and 72 hours of life and 36 week gestational age
To assess mortality at 36 wGA
Time frame: 5 and 30 minutes after the drug injection 24 and 72 hours of life and 36 week gestational 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 18 Apr 2019.
- Derived from this study: PubMed 33954805Brotelande C, Milesi C, Combes C, Durand S, Badr M, Cambonie G. Premedication with ketamine or propofol for less invasive surfactant administration (LISA): observational study in the delivery room. Eur J Pediatr. 2021 Sep;180(9):3053-3058. doi: 10.1007/s00431-021-04103-1. Epub 2021 May 6.
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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.
MILESI Christophe, PUPH study director
University Hospital, Montpellier
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 Premature Neonate, run by University Hospital, Montpellier 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 3 inclusion and 1 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 18 Apr 2019. 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?
Rate of mechanical ventilation (MV) from the start of the LISA procedure up to 2 hours of life (time frame: 2 hours after LISA procedure). 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 NCT03705468, which also lists 1 linked publication.
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 18 Apr 2019.