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

Cooling newborns: what happens to their hearts?

NCT ID NCT05574855

Knowledge-focused Sponsor: Princess Anna Mazowiecka Hospital, Warsaw, Poland 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looked at how therapeutic hypothermia (cooling) affects the heart and brain blood flow in newborns who suffered oxygen loss at birth. Researchers used ultrasound to measure heart function and brain circulation in 113 babies. The goal was to better understand the body's response to cooling and rewarming, which can help doctors improve treatment.

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.

Participants

113 people

The number who actually took part.

Started

Aug 2021

Finished

Feb 2024

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.

Who is studied

This is a multicentre, prospective, case-control, observational study. The number of subjects under observation will be 113 neonates. The enrolment, intervention and assessment schedule is presented in tabel. Initial echocardiography and cerebral and abdominal ultrasonography will be conducted according to physician recommendation by two neonatologist. The study procedure will be explained to patient's guardians who will also receive an information leaflet. Guardians will then be asked to provide two copies of informed consent.

Ages

Up to 7 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: 1. Neonates with gestation age ≥35, whith episode of PA and who were qualified for TH according to the Standards of Medical care of Neonates in Poland (10) was enrolled to the SG 2. Healthy, neonates with gastation \>37 0/7 \< 41 6/7, who underwent ECHO for reasons such as difficult adaptation, gestational diabetes of the mother etc. was enrolled to the CG. Exclusion Criteria: 1. Congenital cardiac abnormalities 2. Genetic abnormalities 3. Absence of parental or guardian consent for participation in the study 4. SGA \<10 centiles

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Haemodynamic instability are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

perinatal asphyxia

As listed by the trial registrant

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

Haemodynamic instability Hypothermia neonatal Perinatal asphyxia

Contacts and locations

Locations

  • Centrum Medyczne "ŻELAZNA"

    Warsaw, 01-004, Poland

  • Department of Neonatology and Neonatal Intensive Care Warsaw Medical University

    Warsaw, 00-315, Poland

  • Lazarski University Faculty of Medicine

    Warsaw, Poland

  • Princess Anna Mazowiecka Hospital

    Warsaw, 00-315, Poland

More trials for these conditions

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