Who is sponsoring NCT03163108?

NCT03163108 is sponsored by University Hospital Tuebingen.

What drugs are being tested in NCT03163108?

Interventions in NCT03163108: Closed-loop automatic oxygen control (CLAC) fast in addition to RMC, Closed-loop automatic oxygen control (CLAC) slow in addition to RMC.

What condition does NCT03163108 study?

NCT03163108 studies Infant Respiratory Distress Syndrome, Ventilator Lung; Newborn.

Is NCT03163108 still recruiting?

NCT03163108 is currently completed. Last updated 15 May 2018.

Last reviewed 2018-05-15 · How we verify

NCT03163108: CLAC-4

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

Closed-loop Automatic Oxygen Control (CLAC-4) in Preterm Infants

Completed NA Last updated 15 May 2018

What this trial tests

NA trial testing Closed-loop automatic oxygen control (CLAC) fast in addition to RMC in Infant Respiratory Distress Syndrome in 19 participants. Completed in 12 January 2018.

Timeline

15 March 2017

Primary endpoint
18 December 2017

12 January 2018

Quick facts

Lead sponsor	University Hospital Tuebingen
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	19
Start date	15 March 2017
Primary completion	18 December 2017
Estimated completion	12 January 2018
Sites	2 locations across Germany

Drugs / interventions tested

Closed-loop automatic oxygen control (CLAC) fast in addition to RMC
Closed-loop automatic oxygen control (CLAC) slow in addition to RMC

Conditions studied

Infant Respiratory Distress Syndrome — all drugs for Infant Respiratory Distress Syndrome →
Ventilator Lung; Newborn — all drugs for Ventilator Lung; Newborn →

Sponsor

University Hospital Tuebingen

Who can join

Eligibility, any sex, with Infant Respiratory Distress Syndrome or Ventilator Lung; Newborn. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Two-center, randomised controlled, cross-over clinical trial in preterm infants born at gestational age below 34+1/7 weeks receiving supplemental oxygen and respiratory support (Continous positive airway pressure (CPAP) or Non-invasive Ventilation (NIV) or Invasive Ventilation (IV)). Routine manual control (RMC) of the fraction of inspired oxygen (FiO2) will be tested against RMC supported by closed-loop automatic control (CLAC) with "slow"-algorithm and RMC supported by CLAC with "fast"-algorithm. The primary hypothesis is, that the use of the "faster" algorithm results in more time within arterial oxygen saturation (SpO2) target range compared to RMC only. The a-priori subordinate hypothesis is, that the faster algorithm is equally effective as the slower algorithm to maintain the SpO2 in the target range.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Is faster better? A randomised crossover study comparing algorithms for closed-loop automatic oxygen control.
Schwarz CE, Kidszun A, Bieder NS, Franz AR, et al · · 2020 · cited 22× · PMID 31527093 · DOI 10.1136/archdischild-2019-317029

Verify or expand the search:

Other recruiting trials for Infant Respiratory Distress Syndrome

Currently open trials in the same condition.

NCT06757543 — A Stepped Wedge Cluster Randomised Trial of Video Versus Direct Laryngoscopy for Intubation of Newborn Infants · NA · recruiting

Other University Hospital Tuebingen trials

Trials by the same sponsor.

NCT07378670 — DEfeating PEnile CAncer-2 · NA · recruiting
NCT07276503 — Verification of a New Predictive Delirium Score in Adults With Elective Cardiac Valve or Bypass Surgery With Perioperati · not yet recruiting
NCT07411365 — Dual-task Cognitive-motor Telerehabilitation in Persons With PD-MCI · NA · not yet recruiting
NCT06953791 — Comparison of Quality of Life During a Flare of Crohn's Disease Treated With Prednisolone or aCDED With PEN in Adult Pat · Phase 2 · recruiting
NCT07378891 — Artificial-Intelligence-based Early Detection of Diabetic Retinopathy (FUNDUS AI) · enrolling by invitation

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 NCT03163108 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
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 Hospital Tuebingen
Last refreshed: 15 May 2018

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/NCT03163108.

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