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Could a blood pressure cuff save tiny lives? new trial explores simple treatment for deadly newborn gut disease

NCT ID NCT05279664

Knowledge-focused Sponsor: The Hospital for Sick Children Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at a procedure called remote ischemic conditioning (RIC) for newborns with necrotizing enterocolitis (NEC), a serious gut disease. RIC involves briefly inflating a blood pressure cuff on the baby's arm to protect the gut from damage. The main goal is to see if a larger, more definitive trial is possible, so it focuses on how many families agree to join and how well the procedure can be masked. About 78 babies will take part to test the feasibility of this approach.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 78 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2023

Expected to finish

Mar 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

0 weeks and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. All gestational age at birth. 2. Current weight ≥600 g 3. Confirmed diagnosis of "medical" NEC based on the joint opinion of two attending experts in the field (two neonatologists or one neonatologist and one pediatric surgeon). 4. NEC diagnosis established within the previous 24 hours. Exclusion Criteria: 1. Indication for surgery in the joint opinion of the attending neonatologist and pediatric surgeon (i.e. surgical NEC). This diagnosis is based on the presence of pneumoperitoneum in the abdominal radiograph and/or failure of medical treatment for NEC 2. Previous episodes of NEC 3. Diagnosis of NEC established \>24 hours ago 4. Major congenital heart disease which needs surgical repair 5. Antecedent limb ischemia/limb thrombotic events, occlusive arterial or venous thrombosis 6. Associated gastrointestinal anomalies including gastroschisis or congenital diaphragmatic hernia.

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Conditions

The condition(s) this trial relates to.

necrotizing enterocolitis Premature Birth

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Necrotizing enterocolitis

Contacts and locations

Locations

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • Mount Sinai Hospital

    Toronto, Ontario, M5G 1X5, Canada

  • Sunnybrook Health Sciences Center

    Toronto, Ontario, M4Y 3M5, Canada

  • The Hospital for Sick Children

    Toronto, Ontario, M5G1X8, Canada

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