Remote Ischemic Conditioning in Necrotizing Enterocolitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-17

Study Completion Date

2019-08-20

Brief Summary

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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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Detailed Description

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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.

Conditions

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Enterocolitis, Necrotizing

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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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).

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

0 Months

Maximum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No