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Remote Ischemic Conditioning in Necrotizing Enterocolitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03860701
Recruitment Status : Completed
First Posted : March 4, 2019
Last Update Posted : October 22, 2020
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Agostino Pierro, The Hospital for Sick Children

Brief Summary:
Necrotizing enterocolitis (NEC) affects up to 10% of very preterm infants. NEC mortality is high (30-50 %) and has remained unchanged over the last decades. New treatments are urgently needed. NEC pathogenesis is multifactorial, but bowel ischemia plays an essential role in NEC development. Remote ischemic conditioning (RIC) consists in inducing brief periods of non-lethal ischemia in a limb distant to an organ suffering from ischemia. RIC has been used in adults, children and term neonates with a variety of diagnosis. However, no study has been done including preterm infants with NEC.

Condition or disease Intervention/treatment
Enterocolitis, Necrotizing Procedure: Remote ischemic conditioning

Detailed Description:
An appropriately sized blood pressure cuff will be applied to an arm or leg and inflated to promote RIC. This study will be conducted in three phases to assess the feasibility and safety of RIC in relation to duration of ischemia time, number of cycles of RIC and whether it is feasible and safe to perform RIC on consecutive days.

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Study Type : Observational
Actual Enrollment : 15 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Remote Ischemic Conditioning in Necrotizing Enterocolitis: Feasibility and Safety Pilot Study.
Actual Study Start Date : December 17, 2018
Actual Primary Completion Date : August 20, 2019
Actual Study Completion Date : August 20, 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: Remote ischemic conditioning
    An appropriately sized blood pressure cuff will be inflated around a limb (systolic blood pressure + 15 mmHg) for different periods of time (1 to up to 4 minutes), times (1 to up to 4 times) and consecutive days (1 to up to 2).


Primary Outcome Measures :
  1. Limb perfusion after Remote Ischemic Conditioning [ Time Frame: 1 days ]
    Limb perfusion will be assessed before (baseline) and after Remote Ischemic Conditioning (RIC). Limb perfusion will be determined by oxygen saturation using pulse oximetry. RIC will be considered feasible and safe if the procedure is completed as planned with no failure of limb re-perfusion. Failure is defined as no return of limb arterial oxygen saturation to baseline 4 minutes after the ischemic phase (re-perfusion time).


Secondary Outcome Measures :
  1. Cutaneous injury [ Time Frame: 1 days ]
    Defined as new-onset skin breakdown, bruising, ecchymosis or petechiae.

  2. Persistent pain [ Time Frame: 1 days ]
    Pain measured according to the premature infant pain profile (PIPP) scores (range 0-21). Pain scores will be obtained immediately before (baseline) and 6 hours after RIC. Persistent pain will be defined as a PIPP score higher than the baseline score.



Information from the National Library of Medicine

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Ages Eligible for Study:   0 Months to 3 Months   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Preterm infants < 36 weeks with NEC (stages I-III as per Bell's modified classification).
Criteria

Inclusion Criteria:

  • Patients with NEC (stages I-III Bell's Classification)
  • Weight greater or equal to 750 g.
  • Gestational age < 36 weeks.
  • Patients whose parents consent to participate in the study.

Exclusion Criteria:

  • Patients with major congenital anomalies
  • No antecedent of limb ischemia/limb thrombotic events.
  • No antecedent diagnosis of occlusive arterial or venous thrombosis
  • Hemodynamic instability

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03860701


Locations
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Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Canadian Institutes of Health Research (CIHR)
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Agostino Pierro, Head of The Division of General and Thoracic Surgery, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT03860701    
Other Study ID Numbers: REB1000061144
First Posted: March 4, 2019    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Enterocolitis
Enterocolitis, Necrotizing
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases