Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Which oxygen level is best for sick newborns? study aims to find out

NCT ID NCT04938167

Knowledge-focused Sponsor: University of California, Davis 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 two different oxygen level targets for newborns who have trouble breathing or a condition called pulmonary hypertension (high blood pressure in the lungs). About 54 babies born at 35 weeks or later are randomly assigned to one of two oxygen goals. Researchers check medical records and heart ultrasounds to see which target leads to better outcomes.

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

54 people

The number who actually took part.

Started

Aug 2021

Expected to finish

Dec 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 to 28 days

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: * Corrected gestational age (postmenstrual age) \> 34 6/7 weeks * postnatal age ≤ 28 d * on respiratory support with invasive mechanical ventilation, non-invasive ventilation, CPAP or high flow nasal cannula (defined as flow rates ≥ 2 LPM with a humidifier), inspired oxygen concentration, FiO2 ≥ 0.3 * and echocardiography shows any finding suggestive of PH (or score \> 0 for PH in table 2). * Infants with congenital diaphragmatic hernia (CDH), Down syndrome, hypoxic ischemic encephalopathy (HIE) on therapeutic hypothermia and patent ductus arteriosus (PDA), patent foramen ovale/atrial septal defect (PFO/ASD) and ventricular septal defect (VSD) (single or multiple) \< 2 mm can be included in the study. Exclusion Criteria: * \< 32 weeks gestation at birth (31 6/7 or lower) * Weight \< 2000 g at the time of enrollment * Severe HRF with OI \> 35 or SpO2 \< 75% on FiO2 = 1.0 on mechanical ventilation for \> 60 minutes in spite of correction of reversible factors such as pneumothorax * A condition or congenital anomaly known to be lethal (high likelihood of death during infancy) - e.g., trisomy 18 or trisomy 13 * Congenital heart disease other than ASD/PFO, PDA or VSD (single or multiple defects) \< 2 mm.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Hypoxemic respiratory failure are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

persistent fetal circulation syndrome respiratory failure

As listed by the trial registrant

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

Hypoxemic respiratory failure Persistent pulmonary hypertension of the newborn

Contacts and locations

Locations

  • University of California-Davis

    Sacramento, California, 95817, United States

More trials for these conditions

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