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Simple pulse test could spot hidden heart defects in newborns

NCT ID NCT03078218

Knowledge-focused Sponsor: University Hospital, Bordeaux 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested whether using a pulse oximeter (a small sensor on the foot or hand) to measure oxygen levels in all seemingly healthy newborns can help find hidden, life-threatening heart defects early. Over 44,000 babies took part. The goal was to see if this screening reduces serious complications and death, and if it is worth the cost for the French healthcare system.

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

44,140 people

The number who actually took part.

Started

Mar 2017

Finished

Jan 2020

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 24 hours

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: BEFORE Period: newborns * aged at birth superior or equal to 35 weeks of gestation (≥ 35+ 0 days weeks of gestation) * borned in metropolitan France in involved maternity wards. * Asymptomatic before the screening (no respiratory signs, neither collapse or cardiac arrest). AFTER Period: newborns * aged at birth superior or equal to 35 weeks of gestation (≥ 35+ 0 days weeks of gestation) * borned in metropolitan France in involved maternity wards. * Asymptomatic before the screening (no respiratory signs, neither collapse or cardiac arrest). * With consent done by the 2 parents. * Parents covered with the French National health insurance Exclusion Criteria: * Newborns with a prenatally diagnosed congenital cyanotic malformation or any other cyanotic affection. * Newborns with a postnatal pre-screening diagnosed congenital cyanotic malformation or any other cyanotic affection.

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Conditions

The condition(s) this trial relates to.

congenital heart disease

As listed by the trial registrant

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

Critical congenital heart disease

Contacts and locations

Locations

  • CH Agen

    Agen, 47000, France

  • CH Angoulême

    Angoulême, 16959, France

  • CH Brive

    Brive-la-Gaillarde, 19100, France

  • CH Châtellerault

    Châtellerault, 86106, France

  • CH Dax

    Dax, 40100, France

  • CH Guéret

    Guéret, 23000, France

  • CH Marmande

    Marmande, 47207, France

  • CH Mont de Marsan

    Mont-de-Marsan, 40024, France

  • CH Niort

    Niort, 79000, France

  • CH Périgueux

    Périgueux, 24000, France

  • CH Robert Boulin

    Libourne, 33505, France

  • CH Rochefort

    Rochefort, 17301, France

  • CH Saint Junien

    Saint-Junien, 87200, France

  • CH Saintes

    Saintes, 17100, France

  • CH Villeneuve-sur-Lot

    Villeneuve-sur-Lot, 47305, France

  • CH d'Arcachon

    La Teste-de-Buch, 33260, France

  • CH de Tulle

    Tulle, 19012, France

  • CH de la Haute Gironde

    Blaye, 33394, France

  • CHU Limoges

    Limoges, 87000, France

  • CHU de Bordeaux

    Pessac, 33604, France

  • CHU de Poitiers

    Poitiers, 86000, France

  • Clinique Emailleurs

    Limoges, 87000, France

  • Clinique Esquirol - Saint Hilaire

    Agen, 47000, France

  • Clinique Jean Villar

    Bruges, 33523, France

  • Clinique Soyaux

    Soyaux, 16800, France

  • Maison de Santé Protestante de Bordeaux Bagatelle

    Talence, 33401, France

  • Maternité Pernelle d'Aufrédy CH de La Rochelle - Ré - Aunis

    La Rochelle, 17019, France

  • Polyclinique Bordeaux Nord Aquitaine

    Bordeaux, 33077, France

  • Polyclinique Rive droite

    Lormont, 33310, France