Evidence map›Paper›PMID 41420760›Full record

ArticlePediatric surgery international2025

Remote ischemic conditioning in necrotizing enterocolitis: an extended phase I safety study.

Yongfang Wu, Niloofar Ganji, Zhou Chen, Mingzhe Hu, Dan Li, Bo Li, Ying Huang, Agostino Pierro, Haitao Zhu

Abstract readClinical Trial, Phase I
PubMed Publisher
In one paragraph

Article in Pediatric surgery international, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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

9 authors.

Yongfang Wu *Neonatal Medical Center, Children's Hospital of Fudan University (Xiamen Branch), Xiamen Children's Hospital, Fujian, 361006, China.
Niloofar Ganji *Division of General and Thoracic Surgery, The Hospital for Sick Children, Toronto, ON, M5G 1X8, Canada.
Zhou Chen *Department of General Surgery, School of Medicine, Shanghai Children's Hospital, Shanghai Jiao Tong University, Shanghai, 200062, China.
Mingzhe HuDepartment of Pediatric Surgery, Children's Hospital of Fudan University (Xiamen Branch), Xiamen Children's Hospital, Fujian, 361006, China.
Dan LiNeonatal Medical Center, Children's Hospital of Fudan University (Xiamen Branch), Xiamen Children's Hospital, Fujian, 361006, China.
Bo LiDivision of General and Thoracic Surgery, The Hospital for Sick Children, Toronto, ON, M5G 1X8, Canada.
Ying HuangNeonatal Medical Center, Children's Hospital of Fudan University (Xiamen Branch), Xiamen Children's Hospital, Fujian, 361006, China.
Agostino PierroDivision of General and Thoracic Surgery, The Hospital for Sick Children, Toronto, ON, M5G 1X8, Canada. agostino.pierro@sickkids.ca.
Haitao ZhuDepartment of General Surgery, School of Medicine, Shanghai Children's Hospital, Shanghai Jiao Tong University, Shanghai, 200062, China. haitaoalex.zhu@gmail.com.

Funding

Canadian Institutes of Health Research, Canadian Institutes of Health Research, Foundation Grants 487457Canadian Institutes of Health Research, Canadian Institutes of Health Research, Foundation Grants 496719Canadian Institutes of Health Research, Foundation Grant 353857Science and Technology Commission of Shanghai Municipality 20Y11906900Shanghai Natural Science Foundation 22ZR1408600Xiamen Science & Technology Bureau "Horse Racing and Unveiling and Commanding" System-Based Science and Technology Program 3502Z20241003
6 · The paper itself

Abstract

objectiveRemote ischemic conditioning (RIC) potentially is an innovative therapeutic strategy for preterm infants with necrotizing enterocolitis (NEC). RIC appears safe in human premature neonates with NEC, as demonstrated by no adverse effects or complications due to RIC in our previous trial. The aim of the current study is to further assess the safety of RIC during its extended application in preterm infants with NEC.

methodsA single center phase I non-randomized trial was conducted. Preterm (< 36 weeks gestational age at birth) infants with confirmed NEC were recruited and received RIC intervention. RIC consisted of four cycles of limb ischemia (5-min via cuff inflation) followed by reperfusion (5-min via cuff deflation), repeated on two consecutive days post enrollment. Demographic and clinical data were collected at enrollment. The primary endpoint of this study was safety defined as perfusion returning to baseline within 5 min after cuff deflation. Secondary endpoints included cutaneous injury and pain (measured by PIPP scores).

resultsA total of 6 neonates were recruited. All neonates were preterm with a birth weight ranging from 450 to 3150 g. NEC was diagnosed between 7 and 30 days and weight at RIC ranged from 780 to 3040 g. Two (33.3%) patients had medical NEC. Four (66.7%) patients underwent RIC postoperatively. RIC was completed in all neonates. Arterial flow and limb perfusion returned to baseline within 5 min in all patients. All patients had a normal grasp reflex both before and after RIC. No new-onset skin lesions were observed. There was no significant difference in PIPP score before and after RIC.

conclusionsRIC intervention with 5-min ischemia-reperfusion cycles is safe. RIC is also safe when extended to extremely preterm neonates with confirmed medical or surgical NEC.

Indexed as

Enterocolitis, NecrotizingInfant, Premature, DiseasesIschemic PreconditioningFemaleHumansInfant, NewbornInfant, PrematureMaleTreatment OutcomeNecrotizing enterocolitisRemote ischemic conditioningSafety study

Identifiers

PMID41420760

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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.