Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 36
SponsorInstitute of Health Information and Statistics of the Czech Republic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

infants born before 31+6 weeks gestation

signed consent for participation in the project and consent for the processing of personal data

diagnosed with bronchopulmonary dysplasia

type of pulmonary ventilation - low-flow nasal cannulas

Disqualifiers

unsigned consent for participation in the project and/or consent for the processing of personal data

child diagnosed with conditions other than bronchopulmonary dysplasia (BPD) at high risk of long-term hypoxia - selected chronic cardiovascular, neurological, and muscular diseases, e.g., significant congenital heart defects, congenital central nervous system developmental disorders, genetic diseases associated with the risk of hypoventilation, central apneas, severe early obstructive sleep apnea

other chronic respiratory diseases besides BPD - e.g., cystic fibrosis, chronic aspiration

insufficient therapy through long-term home oxygen therapy

Trial design

Design model

Single group

Treatments tested in this trial

  • Pulse oximeter

    Device

    To ensure proper treatment, the infant will be continuously monitored with a pulse oximeter. Based on oxygen saturation levels, the treatment may be adjusted according to pre-established protocols. It is required that the saturation stays above a certain value for more than 95 % of the 12-hour measurement period. If the defined saturation values are reached, the parents will reduce the oxygen flow by one degree for 20 minutes in the hospital/home setting (20 minute test) and if the saturation values remain at 93 % or more during this period, overnight 12 hour monitoring will also be performed to confirm stable saturation values of 93 % or more for 95 % or more of the monitoring time. Thanks to modern specialized pulse oximeters, it is possible to ensure accurate, long-term, remotely managed monitoring of the infant and to interactively optimize oxygen therapy based on current oxygen saturation levels.

Treatment groups

70 Participants
are divided into 1 treatment group
Group A: Controlled remote oxygen therapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Average duration of controlled oxygen therapy in a premature infant

Number of days a premature infant stays on oxygen therapy

Time frame
From the enrollment to 4 weeks after discontinuation of home oxygen therapy application in child (complete weaning from oxygen supply)

Secondary outcomes

1

Average number of failures in premature infants before the termination of controlled oxygen therapy

Failure is defined as the need to return to the original flow rate before the last reduction.

Time frame
From the enrollment to 4 weeks after discontinuation of home oxygen therapy application in child (complete weaning from oxygen supply)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institute of Health Information and Statistics of the Czech Republic

Lead sponsor

České Budějovice Hospital

Collaborator

University Hospital Olomouc

Collaborator

Institute for the Care of Mother and Child, Prague, Czech Republic

Collaborator

General University Hospital, Prague

Collaborator