Who is sponsoring NCT03586856?

NCT03586856 is sponsored by Baldvin Jonsson.

What drugs are being tested in NCT03586856?

Interventions in NCT03586856: Nasal mask interface, Nasal prongs interface.

What condition does NCT03586856 study?

NCT03586856 studies Respiration; Insufficient or Poor, Newborn, Infant,Premature.

Is NCT03586856 still recruiting?

NCT03586856 is currently completed. Last updated 13 November 2019.

Last reviewed 2019-11-13 · How we verify

NCT03586856: ToNIL

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

Comparison of Leakage With Nasal Prongs and Nasal Mask Interface in Newborns Receiving CPAP Treatment

Completed NA Last updated 13 November 2019

What this trial tests

NA trial testing Nasal mask interface in Respiration; Insufficient or Poor, Newborn in 50 participants. Completed in 26 October 2019.

Timeline

1 August 2018

Primary endpoint
26 October 2019

26 October 2019

Quick facts

Lead sponsor	Baldvin Jonsson
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	1 August 2018
Primary completion	26 October 2019
Estimated completion	26 October 2019
Sites	2 locations across Sweden

Drugs / interventions tested

Nasal mask interface
Nasal prongs interface

Conditions studied

Respiration; Insufficient or Poor, Newborn — all drugs for Respiration; Insufficient or Poor, Newborn →
Infant,Premature — all drugs for Infant,Premature →

Sponsor

Baldvin Jonsson

Who can join

Under 44 Weeks, any sex, with Respiration; Insufficient or Poor, Newborn or Infant,Premature. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The study is a two-armed randomized cross-over comparison of leakage with nasal prongs and nasal mask interface in newborn infants treated with CPAP, born after 28 weeks of gestational age. For infants with an interface leakage, the trial also includes an observational part evaluating simple measures to reduce leakage. The study will be carried out in the Karolinska University Hospital Stockholm and in the Östersund Hospital.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Interface leakage during neonatal CPAP treatment: a randomised, cross-over trial.
Falk M, Gunnarsdottir K, Baldursdottir S, Donaldsson S, et al · · 2021 · cited 10× · PMID 33963004 · DOI 10.1136/archdischild-2021-321579
Do newborn infants exhale through the CPAP system? Secondary analysis of a randomised cross-over trial.
Gunnarsdottir K, Falk M, Baldursdottir S, Donaldsson S, et al · · 2023 · cited 1× · PMID 36261145 · DOI 10.1136/archdischild-2022-324462

Verify or expand the search:

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 NCT03586856 (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 Baldvin Jonsson
Last refreshed: 13 November 2019

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/NCT03586856.

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