NCT02825953 is a NA clinical trial of surfactant in Respiratory Distress Syndrome, sponsored by nihat demir.

Who is sponsoring NCT02825953?

NCT02825953 is sponsored by nihat demir.

What drugs are being tested in NCT02825953?

Interventions in NCT02825953: surfactant, nasal continuous positive airway pressure, non-invasive intermittent positive-pressure ventilation, Neopuff, neonatal ventilator.

What condition does NCT02825953 study?

NCT02825953 studies Respiratory Distress Syndrome, Surfactant Administration by Aerosolization.

Is NCT02825953 still recruiting?

NCT02825953 is currently status unknown. Last updated 6 July 2016.

Last reviewed 2016-07-06 · How we verify

NCT02825953

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

Does The Surfactant Administration by Aerosolization of Respiratory Distress Syndrome Effective in Spontaneously Breathing Premature Infants ?

Status unknown NA Last updated 6 July 2016

What this trial tests

NA trial testing surfactant in Respiratory Distress Syndrome in 75 participants. Status unknown.

Timeline

1 January 2016

Primary endpoint
1 January 2017

1 January 2017

Quick facts

Lead sponsor	nihat demir
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	75
Start date	1 January 2016
Primary completion	1 January 2017
Estimated completion	1 January 2017

Drugs / interventions tested

surfactant — full drug profile →
nasal continuous positive airway pressure
non-invasive intermittent positive-pressure ventilation
Neopuff
neonatal ventilator

Conditions studied

Respiratory Distress Syndrome — all drugs for Respiratory Distress Syndrome →
Surfactant Administration by Aerosolization — all drugs for Surfactant Administration by Aerosolization →

Sponsor

nihat demir

Who can join

Adults 26 Weeks to 34 Weeks, any sex, with Respiratory Distress Syndrome or Surfactant Administration by Aerosolization. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

The first objective of investigators is to assess the safety of surfactant nebulization in this clinical situation, and to ﬁnd out whether treatment with aerosolized surfactant would reduce the need for mechanical ventilation.
Time frame: within the ﬁrst 72 hour of life
The infants will be stabilised on NCPAP (Neopuff; Fisher and Paykel, Auckland, New Zealand) in the delivery room and during transport to the NICU. NCPAP or NIPPV will be started within 30 min of birth immediately after randomisation. Both NCPAP and NIPPV will be delivered by a neonatal ventilator (Engström Carestation; GE Healthcare, Madison, USA) via short, binasal Cannula (RAM Cannula; Neotech,

Sponsor's own description

The present study was designed to evaluate, in premature babies with RDS breathing spontaneously, the efficacy of combined treatment with nasal continuous positive airway pressure (CPAP) and aerosolized surfactant. The first objective of investigators is to assess the safety of surfactant nebulization in this clinical situation, and to ﬁnd out whether treatment with aerosolized surfactant would reduce the need for mechanical ventilation. And other aim suggest that aerosolized dates compared with dates of INSURE (intubation-surfactant-extubation) and minimally invasive surfactant therapy (MIST) method.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of surfactant

Trials testing the same drug.

NCT03479450 — Surfactant for Neonatal Respiratory Distress Syndrome at High Altitude Areas:a Prospective Cohort Study · unknown
NCT03440333 — Pulmonary Surfactant(PS) Therapy at High Altitude Area · completed

Other recruiting trials for Respiratory Distress Syndrome

Currently open trials in the same condition.

NCT07437391 — Effect of L-Carnitine Supplementation in Preterm Neonates · NA · recruiting
NCT06807983 — LUng and Cardiac Ultrasound for REspiratory Distress in ElDerly · NA · recruiting
NCT07154134 — Endocan and Copeptin Serum Levels in Preterm Neonates With Respiratory Distress Syndrome · recruiting
NCT06684379 — Study on Safety and Efficacy of Two Doses of PRS CK STORM in the Modulation of the Cytokine Storm for the Treatment of A · Phase 1, PHASE2 · recruiting
NCT06430554 — Personalized Ventilation Based on Ventilation-perfusion Mismatch and Lung Recruitability · recruiting

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 NCT02825953 (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 nihat demir
Last refreshed: 6 July 2016

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/NCT02825953.

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