Propofol versus placebo (with rescue with ketamine) before less invasive surfactant administration: study protocol for a multicenter, double-blind, placebo controlled trial (PROLISA)
Abstract Background One major limitation for less invasive surfactant administration (LISA) is the difficulty in providing sedation before this procedure and the competitive risk of respiratory depression versus avoidance of intubation for most sedative or analgesic drugs used in this context. The o...
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| Format: | Article |
| Language: | English |
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BMC
2020-05-01
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| Series: | BMC Pediatrics |
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| Online Access: | http://link.springer.com/article/10.1186/s12887-020-02112-x |
| _version_ | 1828781324487360512 |
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| author | Marie Chevallier Xavier Durrmeyer Anne Ego Thierry Debillon The PROLISA Study Group |
| author_facet | Marie Chevallier Xavier Durrmeyer Anne Ego Thierry Debillon The PROLISA Study Group |
| author_sort | Marie Chevallier |
| collection | DOAJ |
| description | Abstract Background One major limitation for less invasive surfactant administration (LISA) is the difficulty in providing sedation before this procedure and the competitive risk of respiratory depression versus avoidance of intubation for most sedative or analgesic drugs used in this context. The objective of this study is to compare the need for mechanical ventilation within 72 h of life following premedication with propofol, versus placebo (rescue with ketamine), for the LISA procedure in preterm neonates born before 32 weeks gestational age (wGA). Methods ProLISA is a phase III, non-inferiority, multicenter, double blind, randomized, placebo controlled trial designed according to the SPIRIT Statement. Neonates born before 32 wGA in 12 geographically dispersed Neonatal Intensive Care Units in France needing surfactant will be included from September 2019 to September 2022. A sample of 542 patients is needed. The neonate is randomized to the intervention (propofol) or control placebo group. Open label rescue treatment with ketamine is possible in both groups if FANS (Faceless Acute Neonatal pain Scale) is ≥6. To guide drug administration, FANS is scored before attempting laryngoscopy. Once an adequate score has been obtained, LISA is performed according to a standardized protocol. The primary outcome is the need for mechanical ventilation within 72 h of life. Secondary outcomes are tolerance of the procedure, pain evaluation, hemodynamic and neurologic parameters after the intervention, morbidities before discharge and neurodevelopmental assessment at 2 years of age. Discussion This paper describes the first multicenter, double-blind, randomized, placebo-controlled trial on this topic and will provide crucial information to support implementation of the LISA procedure. Trial registration ClinicalTrials.gov: NCT04016246 . Registered 06 June 2019, N°EUDRACT: 2018–002876-41. |
| first_indexed | 2024-12-11T17:31:42Z |
| format | Article |
| id | doaj.art-ca7209688503473a8333e928a8b44cde |
| institution | Directory Open Access Journal |
| issn | 1471-2431 |
| language | English |
| last_indexed | 2024-12-11T17:31:42Z |
| publishDate | 2020-05-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Pediatrics |
| spelling | doaj.art-ca7209688503473a8333e928a8b44cde2022-12-22T00:56:47ZengBMCBMC Pediatrics1471-24312020-05-012011910.1186/s12887-020-02112-xPropofol versus placebo (with rescue with ketamine) before less invasive surfactant administration: study protocol for a multicenter, double-blind, placebo controlled trial (PROLISA)Marie Chevallier0Xavier Durrmeyer1Anne Ego2Thierry Debillon3The PROLISA Study GroupUMR 5525 ThEMAS, CNRS, TIMC-IMAG, Grenoble Alps UniversityNeonatal Intensive Care Unit, Centre Hospitalier Intercommunal de CréteilNeonatal Intensive Care Unit, Grenoble Alps University HospitalUMR 5525 ThEMAS, CNRS, TIMC-IMAG, Grenoble Alps UniversityAbstract Background One major limitation for less invasive surfactant administration (LISA) is the difficulty in providing sedation before this procedure and the competitive risk of respiratory depression versus avoidance of intubation for most sedative or analgesic drugs used in this context. The objective of this study is to compare the need for mechanical ventilation within 72 h of life following premedication with propofol, versus placebo (rescue with ketamine), for the LISA procedure in preterm neonates born before 32 weeks gestational age (wGA). Methods ProLISA is a phase III, non-inferiority, multicenter, double blind, randomized, placebo controlled trial designed according to the SPIRIT Statement. Neonates born before 32 wGA in 12 geographically dispersed Neonatal Intensive Care Units in France needing surfactant will be included from September 2019 to September 2022. A sample of 542 patients is needed. The neonate is randomized to the intervention (propofol) or control placebo group. Open label rescue treatment with ketamine is possible in both groups if FANS (Faceless Acute Neonatal pain Scale) is ≥6. To guide drug administration, FANS is scored before attempting laryngoscopy. Once an adequate score has been obtained, LISA is performed according to a standardized protocol. The primary outcome is the need for mechanical ventilation within 72 h of life. Secondary outcomes are tolerance of the procedure, pain evaluation, hemodynamic and neurologic parameters after the intervention, morbidities before discharge and neurodevelopmental assessment at 2 years of age. Discussion This paper describes the first multicenter, double-blind, randomized, placebo-controlled trial on this topic and will provide crucial information to support implementation of the LISA procedure. Trial registration ClinicalTrials.gov: NCT04016246 . Registered 06 June 2019, N°EUDRACT: 2018–002876-41.http://link.springer.com/article/10.1186/s12887-020-02112-xLess invasive surfactant administrationSedationPropofolKetamineRandomized study |
| spellingShingle | Marie Chevallier Xavier Durrmeyer Anne Ego Thierry Debillon The PROLISA Study Group Propofol versus placebo (with rescue with ketamine) before less invasive surfactant administration: study protocol for a multicenter, double-blind, placebo controlled trial (PROLISA) BMC Pediatrics Less invasive surfactant administration Sedation Propofol Ketamine Randomized study |
| title | Propofol versus placebo (with rescue with ketamine) before less invasive surfactant administration: study protocol for a multicenter, double-blind, placebo controlled trial (PROLISA) |
| title_full | Propofol versus placebo (with rescue with ketamine) before less invasive surfactant administration: study protocol for a multicenter, double-blind, placebo controlled trial (PROLISA) |
| title_fullStr | Propofol versus placebo (with rescue with ketamine) before less invasive surfactant administration: study protocol for a multicenter, double-blind, placebo controlled trial (PROLISA) |
| title_full_unstemmed | Propofol versus placebo (with rescue with ketamine) before less invasive surfactant administration: study protocol for a multicenter, double-blind, placebo controlled trial (PROLISA) |
| title_short | Propofol versus placebo (with rescue with ketamine) before less invasive surfactant administration: study protocol for a multicenter, double-blind, placebo controlled trial (PROLISA) |
| title_sort | propofol versus placebo with rescue with ketamine before less invasive surfactant administration study protocol for a multicenter double blind placebo controlled trial prolisa |
| topic | Less invasive surfactant administration Sedation Propofol Ketamine Randomized study |
| url | http://link.springer.com/article/10.1186/s12887-020-02112-x |
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