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NeO2Matic-Pilot Trial

NCT05629910 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-11-18

No results posted yet for this study

Summary

The main goal of this trial is to test if:

automated adjustment of supplemental oxygen to preterm infants in noninvasive respiratory support based on feedback from a measurement of blood-oxygen saturation

results in more stable blood-oxygenation compared to routine nurse controlled adjustment of oxygen

Conditions

  • Pre-Term
  • Respiratory Distress Syndrome, Newborn
  • Retinopathy of Prematurity
  • Bronchopulmonary Dysplasia

Interventions

DEVICE

O2Matic

During the interventional period the O2Matic will operate in automatic mode using the Neonatal Study Profile. O2Matic will continuously adjust the O2 flow to adjust SpO2 within range based on readings from the pulse oximeter connected to O2Matic, while AIRVO-2 will adjust the flow of ambient air to keep the total gas flow constant.

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Christian Heiring · Rigshospitalet, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2025-01-01
Completion
2025-07-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05629910 on ClinicalTrials.gov