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Completed

NCT Number: NCT03860701

Remote Ischemic Conditioning in Necrotizing Enterocolitis

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.

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Key information

Conditions

Enterocolitis, Necrotizing Digestive System Diseases Enterocolitis Gastroenteritis Gastrointestinal Diseases Intestinal Diseases

Age range

0 month–3 month

Sex eligibility

All sexes

Study type

Observational

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remote Ischemic conditioning

Procedure

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 4, 2019
Registry last updated
Oct 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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