Who is sponsoring NCT04546568?

NCT04546568 is sponsored by University of Edinburgh.

What drugs are being tested in NCT04546568?

Interventions in NCT04546568: Servo control (closed-loop automatic control of the inspiratory fraction of oxygen (FiO2)) - Leoni plus CLAC, Servo control (closed-loop automatic control of the inspiratory fraction of oxygen (FiO2)) - IntellO2 OAM.

What condition does NCT04546568 study?

NCT04546568 studies Premature Infant, Oxygen Therapy, Hypoxia, Hyperoxia, Obstetric Labor, Premature.

Is NCT04546568 still recruiting?

NCT04546568 is currently terminated. Last updated 2 June 2023.

Last reviewed 2023-06-02 · How we verify

NCT04546568

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

SCO2T (Servo vs. Servo)

Terminated NA Last updated 2 June 2023

What this trial tests

NA trial testing Servo control (closed-loop automatic control of the inspiratory fraction of oxygen (FiO2)) - Leoni plus CLAC in Premature Infant in 11 participants. Terminated before completion.

Timeline

10 August 2020

Primary endpoint
3 May 2023

3 May 2023

Quick facts

Lead sponsor	University of Edinburgh
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	11
Start date	10 August 2020
Primary completion	3 May 2023
Estimated completion	3 May 2023
Sites	1 location across United Kingdom

Drugs / interventions tested

Servo control (closed-loop automatic control of the inspiratory fraction of oxygen (FiO2)) - Leoni plus CLAC
Servo control (closed-loop automatic control of the inspiratory fraction of oxygen (FiO2)) - IntellO2 OAM

Conditions studied

Premature Infant — all drugs for Premature Infant →
Oxygen Therapy — all drugs for Oxygen Therapy →
Hypoxia — all drugs for Hypoxia →
Hyperoxia — all drugs for Hyperoxia →

Sponsor

University of Edinburgh

Who can join

2 Days and older, any sex, with Premature Infant or Oxygen Therapy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Most premature babies require oxygen therapy. There is uncertainty about what oxygen levels are the best. The oxygen levels in the blood are measured using a monitor called a saturation monitor and the oxygen the baby breathes is adjusted to keep the level in a target range. Although there is evidence that lower oxygen levels maybe harmful, it is not known how high they need to be for maximum benefit. Very high levels are also harmful. Saturation monitors are not very good for checking for high oxygen levels. For this a different kind of monitor, called a transcutaneous monitor, is better. Keeping oxygen levels stable is usually done by nurses adjusting the oxygen levels by hand (manual control). There is also equipment available that can do this automatically (servo control). It is not known which is best. Studies of automated control have shown that infants spend more time within their intended target oxygen saturation range. These have not included measurements of transcutaneous oxygen. There are no previous studies directly comparing automated respiratory devices. The investigators aim to show the transcutaneous oxygen levels as well as the oxygen saturation levels when babies have their oxygen adjusted using two automated (servo) control devices delivering nasal high flow. For a period of 12 hours each baby will have their oxygen adjusted automatically using each devices for 6 hours respectively. The investigators will compare the range of oxygen levels that are seen between the two respiratory devices.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

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Other University of Edinburgh trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04546568 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Edinburgh
Last refreshed: 2 June 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04546568.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing