Actively Recruiting

Phase Not Applicable
Age: 0 - 36Weeks
All Genders
NCT07161908

Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants

Led by Institute of Health Information and Statistics of the Czech Republic · Updated on 2025-09-09

70

Participants Needed

4

Research Sites

75 weeks

Total Duration

On this page

Sponsors

I

Institute of Health Information and Statistics of the Czech Republic

Lead Sponsor

Č

České Budějovice Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

The project is a national, prospective, multicenter, interventional pilot project focused on controlled remote monitoring and optimization of oxygen therapy for premature infants in the Czech Republic. The primary aim of the project is to prepare, test, and develop a proposal for a national methodology for the care of preterm newborns. This will reduce health risks in premature infants and minimize the negative impacts on the overall development of the child and the family of the premature infant.

CONDITIONS

Official Title

Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants

Who Can Participate

Age: 0 - 36Weeks
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Infants born before 31 weeks and 6 days gestation
  • Signed consent for participation and personal data processing
  • Diagnosed with bronchopulmonary dysplasia
  • Receiving oxygen therapy via low-flow nasal cannulas
Not Eligible

You will not qualify if you...

  • Lack of signed consent for participation or personal data processing
  • Diagnosed with conditions other than bronchopulmonary dysplasia that pose high risk of long-term low oxygen, including significant congenital heart defects, central nervous system developmental disorders, genetic diseases linked to breathing problems, or severe obstructive sleep apnea
  • Having other chronic respiratory diseases besides bronchopulmonary dysplasia such as cystic fibrosis or chronic aspiration
  • Insufficient response to long-term home oxygen therapy
  • Presence of a tracheostomy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

České Budějovice Hospital

České Budějovice, Czech Republic, Czechia

Actively Recruiting

2

University Hospital Olomouc

Olomouc, Czech Republic, Czechia

Actively Recruiting

3

General University Hospital

Prague, Czech Republic, Czechia

Actively Recruiting

4

Institute for the Care of Mother and Child

Prague, Czech Republic, Czechia

Actively Recruiting

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Research Team

D

Daniela Dokoupilová, MSc

CONTACT

L

Lucie Mandelová, Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants | DecenTrialz