Propofol versus placebo (with rescue with ketamine) before less invasive surfactant administration: study protocol for a multicenter, double-blind, placebo controlled trial (PROLISA)

Chevallier, Marie; Durrmeyer, Xavier; Ego, Anne; Debillon, Thierry

doi:10.1186/s12887-020-02112-x

Cited by 20 publications

(13 citation statements)

References 45 publications

(61 reference statements)

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Two trials on this matter are currently ongoing. The rst is being assessed in the PROLISA study, which is investigating the need for mechanical ventilation within 72 h of life following premedication with propofol or placebo before the LISA procedure in preterm infants (NCT04016246) [44]. This trial might provide robust data on premedication use before a routine LISA and the neurodevelopmental outcome at 2 years of age.…”

Section: Discussionmentioning

confidence: 99%

Premedication with fentanyl for less invasive surfactant administration (LISA): A Randomized Controlled Trial

Seth

Mukherjee³

et al. 2021

Preprint

View full text Add to dashboard Cite

Currently, there is no consensus regarding analgesic premedication before the LISA procedure. In this randomized controlled trial, we compared the level of comfort of preterm infants receiving fentanyl as analgesic versus no fentanyl during LISA procedure. We randomized 34 preterm infants of 28+ 0 − 33+ 6 weeks of gestation with RDS within 6 h of birth to receive either fentanyl (1 µg /kg intravenous) or no premedication during LISA procedure. Primary objective was to assess the proportion of infants to be comfortable during the procedure (R-PIPP score < 10) and secondarily complications occurring during the procedure, hemodynamically significant patent ductus arteriosus (hsPDA), intraventricular hemorrhage (IVH) (≥ grade 3), bronchopulmonary dysplasia (BPD) and composite outcome of BPD/mortality. Proportion of infants with a R-PIPP score < 10 during LISA was significantly higher in the fentanyl group (13/17 (76.5%) vs 6/17 (35.3%); p value 0.036). There were no differences in secondary outcome parameters. Conclusion: Low dose fentanyl during LISA procedure resulted in more comfort in preterm infants and without increased complication of both the LISA procedure and fentanyl administration. Further studies are needed to determine the safest and most effective pharmacologic measures to prevent pain and discomfort during LISA. Trial registration: www.ctri.nic.in id CTRI/2020/08/027144, registration date August 14, 2020

show abstract

Section: Discussionmentioning

confidence: 99%

Premedication with fentanyl for less invasive surfactant administration (LISA): A Randomized Controlled Trial

Seth

Mukherjee³

et al. 2021

Preprint

View full text Add to dashboard Cite

show abstract

“…It is likely that the optimal approach to this dilemma in new respiratory support techniques such as noninvasive respiratory support and the use of LISA/MIST has not yet been determined. Few studies to date have directly assessed pain and distress in infants during LISA/MIST procedures, and this should be a priority, but will require careful consideration of the ethical issues involved 75 . There is a need to clarify, through rigorous research, both risks and benefits associated with this procedure.…”

Section: Discussionmentioning

confidence: 99%

New techniques, new challenges—The dilemma of pain management for less invasive surfactant administration?

Balakrishnan

Sanghera

Boyle

2020

Paediatric and Neonatal Pain

View full text Add to dashboard Cite

Recent years have seen the increasing use of noninvasive respiratory support in preterm infants with the aim of minimizing the risk of mechanical ventilation and subsequent bronchopulmonary dysplasia. Respiratory distress syndrome is the most common respiratory diagnosis in preterm infants, and is best treated by administration of surfactant. Until recently, this has been performed via an endotracheal tube using premedication, which has often included opiate analgesia; subsequently, the infant has been ventilated. Avoidance of mechanical ventilation, however, does not negate the need for surfactant therapy. Less invasive surfactant administration (LISA) in spontaneously breathing infants is increasing in popularity, and appears to have beneficial effects. However, laryngoscopy is necessary, which carries adverse effects and is painful for the infant. Conventional methods of premedication for intubation tend to reduce respiratory drive, which increases the likelihood of ventilation being required. This has led to intense debate about the best strategy for providing appropriate treatment, taking into account both the respiratory needs of the infant and the need to alleviate procedural pain. Currently, clinical practice varies considerably and there is no consensus with respect to optimal management. This review seeks to summarize the benefits, risks, and challenges associated with this new approach.

show abstract

“…To enhance acceptance among healthcare professionals, LISA should not be considered as a single strategy but rather as part of a "less intensive support bundle," including delayed cord clamping, nCPAP for initial stabilization (even with high PEEP levels of ≥8 cm H 2 0), and caffeine administration to promote respiratory drive in the first hours of life [43][44][45]. Evidence on the specific impact of each "bundle" component on LISA effectiveness is still limited [46][47][48].…”

Section: Safety Of Lisamentioning

confidence: 99%

The Miracles of Surfactant: Less Invasive Surfactant Administration, Nebulization, and Carrier of Topical Drugs

2021

View full text Add to dashboard Cite

Surfactant replacement therapy (SRT) has long become the standard of care in the treatment of neonatal respiratory distress syndrome (RDS), significantly decreasing acute pulmonary morbidity and mortality in preterm infants. For decades, this beneficial replacement therapy has been administered via endotracheal tube. Despite significantly improving the outcome of RDS, however, the burden of bronchopulmonary dysplasia remains, in particular, in very immature preterm infants. Acknowledging the direct relationship between exposure to and duration of invasive mechanical ventilation and chronic lung disease, the latter has been gradually replaced by noninvasive ventilation strategies in neonatal RDS. This replacement is strongly related to the demand for similarly noninvasive modes of surfactant administration. Alternative techniques in spontaneously breathing infants have evolved, including less invasive techniques using thin catheters (less invasive surfactant administration and minimally invasive surfactant treatment) as well as nebulization of surfactant, although the latter is not ready for clinical application yet. In addition, given their therapeutic delivery to the lungs and subsequent alveolar distribution, surfactant preparations represent an attractive vehicle for pulmonary deposition of drugs in preterm infants. Further improvement of SRT and expansion of the field of application of lung surfactant may hold additional benefits, especially in the treatment of the most immature preterm infants.

show abstract

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.

Cited by 20 publications

References 45 publications

Premedication with fentanyl for less invasive surfactant administration (LISA): A Randomized Controlled Trial

Premedication with fentanyl for less invasive surfactant administration (LISA): A Randomized Controlled Trial

New techniques, new challenges—The dilemma of pain management for less invasive surfactant administration?

The Miracles of Surfactant: Less Invasive Surfactant Administration, Nebulization, and Carrier of Topical Drugs

Contact Info

Product

Resources

About