ArticleBMC pediatrics2020
Propofol versus placebo (with rescue with ketamine) before less invasive surfactant administration: study protocol for a multicenter, double-blind, placebo controlled trial (PROLISA).
Article in BMC pediatrics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Respiratory Effect of the LISA (Less Invasive Surfactant Administration) Method With Sedation by Propofol Versus Absence of Sedation: Double-blind Comparative Randomized Clinical Trial.
Dexmedetomidine for LISA Procedure in Preterm Infants: a Pilot Study
Use of Premedication for Less Invasive Surfactant Administration: A Randomized Control Trial
Who cites it
9 citing papers in PubMed, 1 synthesis or guideline pooled it, 23 citations in OpenAlex.
- Surfactant therapy via thin catheter in preterm infants with or at risk of respiratory distress syndrome.The Cochrane database of systematic reviews · 2021Pooled it
- Can non-pharmacological comfort care replace fentanyl in LISA? The NONA-LISA feasibility study.Pediatric research · 2026Trial
- Dexmedetomidine for LISA procedure: a prospective observational single center experience.Italian journal of pediatrics · 2026Observational
- Sedation and Analgesia for Intubation, LISA, and INSURE Procedures in Israeli NICUs: Caregivers' Practices and Perspectives.Journal of clinical medicine · 2025Article
- Association of Administration of Surfactant Using Less Invasive Methods With Outcomes in Extremely Preterm Infants Less Than 27 Weeks of Gestation.JAMA network open · 2022Article
- Premedication before laryngoscopy in neonates: Evidence-based statement from the French society of neonatology (SFN).Frontiers in pediatrics · 2022Review
- Alternative Methods of Surfactant Administration in Preterm Infants with Respiratory Distress Syndrome: State of the Art.Turkish archives of pediatrics · 2021Article
- Less invasive surfactant administration is associated with a higher need for nonpharmacological pain-relieving interventions compared to the intubation-surfactant extubation technique in preterm infants.Paediatric & neonatal pain · 2021Article
- New techniques, new challenges-The dilemma of pain management for less invasive surfactant administration?Paediatric & neonatal pain · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 3 institutions in 1 country.
Funding
Abstract
backgroundOne 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).
methodsProLISA 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 registrationClinicalTrials.gov: NCT04016246. Registered 06 June 2019, N°EUDRACT: 2018-002876-41.
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Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.