Evidence map›Paper›PMID 38200325›Full record

ArticlePediatric research2024

NON-pharmacological Approach Less Invasive Surfactant Administration (NONA-LISA) trial: protocol for a randomised controlled trial.

Niklas Breindahl, Tine Brink Henriksen, Christian Heiring, Emma Therese Bay, Jannie Haaber, Tenna Gladbo Salmonsen, Emma Louise Malchau Carlsen, Gitte Zachariassen, Peter Agergaard, Anne-Cathrine Finnemann Viuff and 3 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Pediatric research, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05609877 (NON-pharmacological Approach Less Invasive Surfactant Administration), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

NCT05609877 narecruitingnot on this map

NON-pharmacological Approach Less Invasive Surfactant Administration (NONA-LISA) Trial: Protocol for a Randomised Controlled Trial

TypeinterventionalSponsorRigshospitalet, DenmarkRan2024 to 2029Enrolled324ConditionsRespiratory Distress Syndrome in Premature InfantArmsIsotonic saline, Less Invasive Surfactant Administration (LISA), Fentanyl, Non-pharmacological standard operating procedure
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Trial
  2. Vikings, LISA and pain killers….Pediatric research · 2026
    Article
  3. Article
  4. Article
  5. Article
  6. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Niklas BreindahlDepartment of Neonatal and Paediatric Intensive Care, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark. Niklas.breindahl@gmail.com.ORCID 0000-0003-3016-3567
Tine Brink HenriksenDepartment of Paediatrics and Adolescent Medicine, Aarhus University Hospital, Aarhus, Denmark.
Christian HeiringDepartment of Neonatal and Paediatric Intensive Care, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
Emma Therese BayDepartment of Neonatal and Paediatric Intensive Care, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
Jannie HaaberDepartment of Neonatal and Paediatric Intensive Care, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
Tenna Gladbo SalmonsenDepartment of Paediatrics and Adolescent Medicine, Aarhus University Hospital, Aarhus, Denmark.
Emma Louise Malchau CarlsenDepartment of Neonatal and Paediatric Intensive Care, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
Gitte ZachariassenHans Christian Andersen Children's Hospital, Odense University Hospital and University of Southern Denmark, Odense, Denmark.
Peter AgergaardDepartment of Paediatrics and Adolescent Medicine, Aarhus University Hospital, Aarhus, Denmark.
Anne-Cathrine Finnemann ViuffDivision of Neonatology, Department of Paediatric and Adolescent Medicine, Aalborg University Hospital, Aalborg, Denmark.
Lars BenderDivision of Neonatology, Department of Paediatric and Adolescent Medicine, Aalborg University Hospital, Aalborg, Denmark.
Martin Grønnebæk TolsgaardDepartment of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
Lise AunsholtDepartment of Neonatal and Paediatric Intensive Care, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.

Funding

Chiesi Denmark, a subsidiary of Chiesi Farmaceutici, ItalyCopenhagen University
6 · The paper itself

Abstract

introductionUsing pre-procedure analgesia with the risk of apnoea may complicate the Less Invasive Surfactant Administration (LISA) procedure or reduce the effect of LISA.

methodsThe NONA-LISA trial (ClinicalTrials.gov, NCT05609877) is a multicentre, blinded, randomised controlled trial aiming at including 324 infants born before 30 gestational weeks, meeting the criteria for surfactant treatment by LISA. Infants will be randomised to LISA after administration of fentanyl 0.5-1 mcg/kg intravenously (fentanyl group) or isotonic saline solution intravenously (saline group). All infants will receive standardised non-pharmacological comfort care before and during the LISA procedure. Additional analgesics will be provided at the clinician's discretion. The primary outcome is the need for invasive ventilation, meaning mechanical or manual ventilation via an endotracheal tube, for at least 30 min (cumulated) within 24 h of the procedure. Secondary outcomes include the modified COMFORTneo score during the procedure, bronchopulmonary dysplasia at 36 weeks, and mortality at 36 weeks. DISCUSSION: The NONA-LISA trial has the potential to provide evidence for a standardised approach to relief from discomfort in preterm infants during LISA and to reduce invasive ventilation. The results may affect future clinical practice. IMPACT: Pre-procedure analgesia is associated with apnoea and may complicate procedures that rely on regular spontaneous breathing, such as Less Invasive Surfactant Administration (LISA). This randomised controlled trial addresses the effect of analgesic premedication in LISA by comparing fentanyl with a placebo (isotonic saline) in infants undergoing the LISA procedure. All infants will receive standardised non-pharmacological comfort. The NONA-LISA trial has the potential to provide evidence for a standardised approach to relief from discomfort or pain in preterm infants during LISA and to reduce invasive ventilation. The results may affect future clinical practice regarding analgesic treatment associated with the LISA procedure.

Indexed as

FentanylInfant, PrematurePulmonary SurfactantsRespiratory Distress Syndrome, NewbornBronchopulmonary DysplasiaFemaleGestational AgeHumansInfant, NewbornMaleRandomized Controlled Trials as TopicRespiration, ArtificialTreatment OutcomeFentanylPulmonary Surfactants

Identifiers

PMID38200325
PMCPMC11502479

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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.