Evidence map›Paper›PMID 40753114›Full record

Trial reportPediatric research2026

Can non-pharmacological comfort care replace fentanyl in LISA? The NONA-LISA feasibility study.

Niklas Breindahl, Tine Brink Henriksen, Christian Heiring, Emma Therese Bay, Jannie Haaber, Tenna Gladbo Salmonsen, Peter Agergaard, Emma Louise Malchau Carlsen, Martin Grønnebæk Tolsgaard, Lise Aunsholt

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Pediatric research, 2026. 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 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Review
  2. Vikings, LISA and pain killers….Pediatric research · 2026
    Article
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

10 authors.

Niklas BreindahlDepartment of Neonatal and Pediatric Intensive Care, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark. Niklas.breindahl@regionh.dk.ORCID http://orcid.org/0000-0003-3016-3567
Tine Brink HenriksenDepartment of Paediatrics and Adolescent Medicine, Aarhus University Hospital, Aarhus, Denmark.
Christian HeiringDepartment of Neonatal and Pediatric Intensive Care, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
Emma Therese BayDepartment of Neonatal and Pediatric Intensive Care, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
Jannie HaaberDepartment of Neonatal and Pediatric Intensive Care, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
Tenna Gladbo SalmonsenDepartment of Paediatrics and Adolescent Medicine, Aarhus University Hospital, Aarhus, Denmark.
Peter AgergaardDepartment of Paediatrics and Adolescent Medicine, Aarhus University Hospital, Aarhus, Denmark.
Emma Louise Malchau CarlsenDepartment of Neonatal and Pediatric Intensive Care, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
Martin Grønnebæk TolsgaardDepartment of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
Lise AunsholtDepartment of Neonatal and Pediatric Intensive Care, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOptimal comfort strategies in LISA remain unclear. This study aimed to evaluate the feasibility of a standardised approach to non-pharmacological comfort care guided by the COMFORTneo score in infants randomised to receive fentanyl or saline as premedication for LISA.

methodsInfants born before 30 weeks' gestation were randomised to receive isotonic saline or fentanyl 0.5-1 mcg/kg intravenously as premedication for LISA. Both groups received standardised non-pharmacological comfort care. The outcomes were a modified COMFORTneo score ≥14 during the procedure, need for open-label fentanyl administration during the procedure, and inclusion rate using deferred consent. The NONA-LISA trial was registered on clinicaltrials.gov (NCT05609877).

resultsFrom September 2023 to May 2024, 17 infants were randomised (median gestational age, 28 weeks; 77% male); eight received fentanyl and nine received saline. Modified COMFORTneo score ≥14 occurred in 4/8 (fentanyl) and 3/9 (saline), and most cases were alleviated with improved non-pharmacological comfort care only. Two infants (saline) received open-label fentanyl.

conclusionsPerforming LISA with saline and standardised non-pharmacological comfort care guided by the modified COMFORTneo score was feasible. Pausing the procedure and improving non-pharmacological comfort care was sufficient in most cases with a modified COMFORTneo score ≥14 regardless of whether fentanyl or saline was used. IMPACT: The Less Invasive Surfactant Administration (LISA) relies on regular spontaneous breathing to be effective. Analgesic or sedating premedication and a painful or uncomfortable stimulus can cause hypoventilation, which may prevent the LISA method from achieving its full potential. This feasibility study assesses if standardised non-pharmacological comfort care guided by the modified COMFORTneo score is feasible during LISA. Performing LISA with saline and standardised non-pharmacological comfort care guided by the modified COMFORTneo score is feasible and safe. It is possible to blind the use of premedication, and inclusion via deferred consent is feasible.

Indexed as

Analgesics, OpioidFentanylPatient ComfortFeasibility StudiesFemaleGestational AgeHumansInfant, NewbornMalePremedicationAnalgesics, OpioidFentanyl

Identifiers

PMID40753114
PMCPMC13102722

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.