Evidence map›Paper›PMID 35940871›Full record

Trial reportArchives of disease in childhood. Fetal and neonatal edition2023

Remote ischaemic conditioning in necrotising enterocolitis: a phase I feasibility and safety study.

Carlos Zozaya, Niloofar Ganji, Bo Li, Maarten Janssen Lok, Carol Lee, Yuhki Koike, Estelle Gauda, Martin Offringa, Simon Eaton, Prakeshkumar S Shah and 1 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Archives of disease in childhood. Fetal and neonatal edition, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03860701 (Remote Ischemic Conditioning in Necrotizing Enterocolitis), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
2.1field-weighted citation impact, top 11% of its field
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.

NCT03860701 completednot on this map

Remote Ischemic Conditioning in Necrotizing Enterocolitis: Feasibility and Safety Pilot Study.

TypeobservationalSponsorThe Hospital for Sick ChildrenRan2018 to 2019Enrolled15ConditionsEnterocolitis, NecrotizingArmsRemote ischemic conditioning
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 14 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Review
  8. 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

11 authors at 5 institutions in 3 countries.

Carlos ZozayaDivision of Neonatology, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.ORCID http://orcid.org/0000-0003-0062-9258
Niloofar GanjiTranslational Medicine, Hospital for Sick Children Research Institute, University of Toronto, Toronto, Ontario, Canada.ORCID http://orcid.org/0000-0002-6705-2812
Bo LiTranslational Medicine, Hospital for Sick Children Research Institute, University of Toronto, Toronto, Ontario, Canada.
Maarten Janssen LokTranslational Medicine, Hospital for Sick Children Research Institute, University of Toronto, Toronto, Ontario, Canada.
Carol LeeTranslational Medicine, Hospital for Sick Children Research Institute, University of Toronto, Toronto, Ontario, Canada.
Yuhki KoikeDepartments of Gastrointestinal and Pediatric Surgery, Mie University, Tsu, Mie, Japan.
Estelle GaudaDivision of Neonatology, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.
Martin OffringaChild Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Ontario, Canada.ORCID http://orcid.org/0000-0002-4402-5299
Simon EatonPaediatric Surgery, Institute of Child Health, Great Ormond Street Hospital for Children, London, UK.ORCID http://orcid.org/0000-0003-0892-9204
Prakeshkumar S ShahDepartment of Paediatrics, Mount Sinai Hospital, Toronto, Ontario, Canada.
Agostino PierroTranslational Medicine, Hospital for Sick Children Research Institute, University of Toronto, Toronto, Ontario, Canada agostino.pierro@sickkids.ca.
University of Toronto · CAGreat Ormond Street Hospital · GBHospital for Sick Children · CAMie University · JPMount Sinai Hospital · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveRemote ischaemic conditioning (RIC) improves the outcome of experimental necrotising enterocolitis (NEC) by preserving intestinal microcirculation. The feasibility and safety of RIC in preterm infants with NEC are unknown. The study aimed to assess the feasibility and safety of RIC in preterm infants with suspected or confirmed NEC.

designPhase I non-randomised pilot study conducted in three steps: step A to determine the safe duration of limb ischaemia (up to 4 min); step B to assess the safety of 4 repeated cycles of ischaemia-reperfusion at the maximum tolerated duration of ischaemia determined in step A; step C to assess the safety of applying 4 cycles of ischaemia-reperfusion on two consecutive days.

settingLevel III neonatal intensive care unit, The Hospital for Sick Children (Toronto, Canada). PATIENTS: Fifteen preterm infants born between 22 and 33 weeks gestational age.

interventionFour cycles of ischaemia (varying duration) applied to the limb via a manual sphygmomanometer, followed by reperfusion (4 min) and rest (5 min), repeated on two consecutive days. OUTCOMES: The primary outcomes were (1) feasibility defined as RIC being performed as planned in the protocol, and (2) safety defined as perfusion returning to baseline within 4 min after cuff deflation.

resultsFour cycles/day of limb ischaemia (4 min) followed by reperfusion (4 min) and a 5 min gap, repeated on two consecutive days was feasible and safe in all neonates with suspected or confirmed NEC.

conclusionsThis study is pivotal for designing a future randomised controlled trial to assess the efficacy of RIC in preterm infants with NEC. TRIAL REGISTRATION NUMBER: NCT03860701.

Indexed as

Enterocolitis, NecrotizingInfant, Newborn, DiseasesChildFeasibility StudiesHumansInfant, NewbornInfant, PrematureIschemiaPilot Projectsgastroenterologyneonatology

Identifiers

PMID35940871
PMCPMC9763186
OpenAlexW4290721945

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.