NCT00244101 is a Phase 3 clinical trial of PS Group in Respiratory Distress Syndrome, Newborn, sponsored by Vermont Oxford Network.

Who is sponsoring NCT00244101?

NCT00244101 is sponsored by Vermont Oxford Network.

What drugs are being tested in NCT00244101?

Interventions in NCT00244101: PS Group, NCPAP Group, ISX Group.

What condition does NCT00244101 study?

NCT00244101 studies Respiratory Distress Syndrome, Newborn.

Is NCT00244101 still recruiting?

NCT00244101 is currently completed. Last updated 4 January 2023.

Are results published for NCT00244101?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-01-04 · How we verify

NCT00244101

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

Delivery Room Management of Premature Infants at High Risk of Respiratory Distress Syndrome

Completed Phase 3 Results posted Last updated 4 January 2023

What this trial tests

Phase 3 trial testing PS Group in Respiratory Distress Syndrome, Newborn in 648 participants. Completed in 1 June 2011.

Timeline

1 August 2003

Primary endpoint
1 June 2009

1 June 2011

Quick facts

Lead sponsor	Vermont Oxford Network
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	648
Start date	1 August 2003
Primary completion	1 June 2009
Estimated completion	1 June 2011
Sites	1 location across United States

Drugs / interventions tested

PS Group
NCPAP Group
ISX Group — full drug profile →

Conditions studied

Respiratory Distress Syndrome, Newborn — all drugs for Respiratory Distress Syndrome, Newborn →

Sponsor

Vermont Oxford Network

Who can join

Adults 26 Weeks to 29 Weeks, any sex, with Respiratory Distress Syndrome, Newborn. 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.

Death or Chronic Lung Disease
Time frame: at 36 weeks postmenstrual age
Death
Time frame: 36 weeks adjusted age

Sponsor's own description

The best mode of delivery room stabilization for premature infants at high risk for respiratory distress syndrome is unknown. The protocol evaluates the impact of three distinct methods of post-delivery stabilization and subsequent early respiratory care on chronic lung disease and survival in premature infants at high risk for respiratory distress syndrome.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Respiratory Distress Syndrome, Newborn

Currently open trials in the same condition.

NCT07344714 — Predicting the Need for Prolonged Respiratory Support in Neonates Delivered in a Lower-Level NICU Setting · recruiting
NCT07514481 — LISA vs Endotracheal Surfactant in Preterm Neonates: A Lung Ultrasound Distribution Study · NA · recruiting
NCT06880016 — Evaluation of Serial Lung Ultrasound Data After Surfactant Treatments Applied With Different Methods in Preterm Babies · NA · recruiting
NCT06007547 — Prophylactic Minimally Invasive Surfactant Evaluation · Phase 4 · 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 NCT00244101 (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 Vermont Oxford Network
Last refreshed: 4 January 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/NCT00244101.

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