NCT00244101

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
648

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Aug 2003

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 25, 2005

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

September 14, 2012

Completed
Last Updated

January 18, 2023

Status Verified

November 1, 2022

Enrollment Period

5.8 years

First QC Date

October 24, 2005

Results QC Date

August 16, 2012

Last Update Submit

January 4, 2023

Conditions

Respiratory Distress Syndrome, Newborn

Keywords

Prematurityrespiratory distress syndromesurfactantnasal continuous positive airway pressure

Outcome Measures

Primary Outcomes (2)

  • Death or Chronic Lung Disease

    at 36 weeks postmenstrual age

  • Death

    36 weeks adjusted age

Study Arms (3)

PS Group

ACTIVE COMPARATOR

Intubation, prophylactic surfactant administration shortly after delivery, and subsequent stabilization on ventilator support.

Drug: PS Group

NCPAP Group

EXPERIMENTAL

Early stabilization on nasal continuous positive airway pressure (NCPAP) with selected intubation and surfactant administration for clinical indications.

Device: NCPAP Group

ISX Group

EXPERIMENTAL

Intubation, prophylactic surfactant administration shortly after delivery, and rapid extubation to nasal CPAP.

Drug: ISX Group

Interventions

PS GroupDRUG

Intubation, prophylactic surfactant administration shortly after delivery, and subsequent stabilization on ventilator support.

Also known as: Prophylactic Surfactant Group
PS Group
NCPAP GroupDEVICE

Early stabilization on nasal continuous positive airway pressure (NCPAP) with selected intubation and surfactant administration for clinical indications.

Also known as: Nasal CPAP group
NCPAP Group
ISX GroupDRUG

Intubation, prophylactic surfactant administration shortly after delivery, and rapid extubation to nasal CPAP.

Also known as: Intubation, Surfactant Administration, Extubation to Nasal CPAP. ENSURE.
ISX Group

Eligibility Criteria

Age26 Weeks - 29 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Imminent delivery
  • No potentially life-threatening congenital anomaly or genetic syndrome
  • No known lung maturity
  • Antenatal steroid status known
  • Written, informed consent obtained (on admission or prior to delivery).

You may not qualify if:

  • Stillborn (Apgar score of 0 at one minute of age)
  • Noted to have a potentially life-threatening congenital anomaly or genetic syndrome noted immediately after delivery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vermont Oxford Network

Burlington, Vermont, 05401, United States

Location

Related Publications (1)

  • Dunn MS, Kaempf J, de Klerk A, de Klerk R, Reilly M, Howard D, Ferrelli K, O'Conor J, Soll RF; Vermont Oxford Network DRM Study Group. Randomized trial comparing 3 approaches to the initial respiratory management of preterm neonates. Pediatrics. 2011 Nov;128(5):e1069-76. doi: 10.1542/peds.2010-3848. Epub 2011 Oct 24.

    PMID: 22025591RESULT

MeSH Terms

Conditions

Respiratory Distress Syndrome, NewbornPremature BirthRespiratory Distress Syndrome

Interventions

Intubation

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsInvestigative Techniques

Limitations and Caveats

The study was stopped after recruitment reached 74% of the projected sample size because of difficulties with enrollment. Because this study could not be blinded, there was a possibility of bias influencing the outcomes if providers managing the infants did not follow strict guidelines.

Results Point of Contact

Title
Roger F. Soll, MD
Organization
Vermont Oxford Network
roger.soll@uvmhealth.org
802 865 4814

Study Officials

  • Roger F Soll, MD

    Vermont Oxford Network

    PRINCIPAL INVESTIGATOR

  • Michael Dunn, MD

    Sunnybrook and Women's Hospital, Toronto, Ontario, Canada

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2005

First Posted

October 25, 2005

Study Start

August 1, 2003

Primary Completion

June 1, 2009

Study Completion

June 1, 2011

Last Updated

January 18, 2023

Results First Posted

September 14, 2012

Record last verified: 2022-11

Locations

US(1)