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Tiny sensor, tiny patients: new catheter designed for preemies under 2 pounds

NCT ID NCT05427929

Knowledge-focused Sponsor: Mount Sinai Hospital, Canada 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests a new, smaller feeding tube with built-in sensors to measure breathing signals in extremely premature babies (under 1000 grams). The current standard tube is too long for these tiny infants, so the new design shortens the sensor spacing to fit better. Ten babies already on a special ventilator called NAVA will try the new tube to see if it works as well as the standard one.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 10 people

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

Started

Jan 2023

Expected to finish

Jun 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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Neonates with current weight \<1000g who are already receiving invasive or non-invasive NAVA ventilatory support using the standard 6 mm IED Edi catheter will be eligible for recruitment. Exclusion Criteria: * Infants deemed to be unstable by the attending clinician from a respiratory or hemodynamic perspective * Known congenital or chromosomal anomalies * Any acute illness such as sepsis, necrotizing enterocolitis or acute pulmonary hypertension * Parental consent not available

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Conditions

The condition(s) this trial relates to.

newborn respiratory distress syndrome Premature Birth Respiratory Distress Syndrome, Newborn

As listed by the trial registrant

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

Infant, premature Respiratory distress syndrome, newborn

Contacts and locations

Locations

  • Mount Sinai Hospital

    Toronto, Ontario, M5G 1X5, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.