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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vermont Oxford Network
ClinicalTrials.gov Identifier:
NCT00244101
First received: October 24, 2005
Last updated: August 16, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Respiratory Distress Syndrome, Newborn
Drug: PS Group
Device: NCPAP Group
Drug: ISX Group
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Delivery Room Management of Premature Infants at High Risk of Respiratory Distress Syndrome

Resource links provided by NLM:


Further study details as provided by Vermont Oxford Network:

Primary Outcome Measures:
  • Death or Chronic Lung Disease [ Time Frame: at 36 weeks postmenstrual age ] [ Designated as safety issue: No ]
  • Death [ Time Frame: 36 weeks adjusted age ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complications of Prematurity [ Time Frame: prior to hospital discharge ] [ Designated as safety issue: Yes ]
  • Days of Ventilator Support [ Time Frame: prior to hospital discharge ] [ Designated as safety issue: No ]
  • Days in Hospital [ Time Frame: prior to hospital discharge ] [ Designated as safety issue: No ]
  • Parental Questionnaire for Health Status [ Time Frame: at 24 months of age ] [ Designated as safety issue: Yes ]

Enrollment: 648
Study Start Date: August 2003
Study Completion Date: June 2011
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PS Group
Intubation, prophylactic surfactant administration shortly after delivery, and subsequent stabilization on ventilator support.
Drug: PS Group
Intubation, prophylactic surfactant administration shortly after delivery, and subsequent stabilization on ventilator support.
Other Name: Prophylactic Surfactant Group
Experimental: NCPAP Group
Early stabilization on nasal continuous positive airway pressure (NCPAP) with selected intubation and surfactant administration for clinical indications.
Device: NCPAP Group
Early stabilization on nasal continuous positive airway pressure (NCPAP) with selected intubation and surfactant administration for clinical indications.
Other Name: Nasal CPAP group
Experimental: ISX Group
Intubation, prophylactic surfactant administration shortly after delivery, and rapid extubation to nasal CPAP.
Drug: ISX Group
Intubation, prophylactic surfactant administration shortly after delivery, and rapid extubation to nasal CPAP.
Other Name: Intubation, Surfactant Administration, Extubation to Nasal CPAP. ENSURE.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   26 Weeks to 29 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Infants likely to be delivered to women presenting to a participating Vermont Oxford Network Center at high risk of premature delivery at gestational age 26 + 0 to 29 + 6 weeks will be eligible for inclusion. Specific inclusion criteria that must be met prior to randomization include:

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

Exclusion Criteria:

  1. Stillborn (Apgar score of 0 at one minute of age)
  2. Noted to have a potentially life-threatening congenital anomaly or genetic syndrome noted immediately after delivery.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00244101

Locations
United States, Vermont
Vermont Oxford Network
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
Vermont Oxford Network
Investigators
Principal Investigator: Roger F Soll, MD Director of Clinical Trials, Vermont Oxford Network
Principal Investigator: Michael Dunn, MD Chief of Newborn and Developmental Pediatrics, Sunnybrook and Women's Hospital, Toronto, Ontario, Canada
  More Information

Additional Information:
No publications provided by Vermont Oxford Network

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Vermont Oxford Network
ClinicalTrials.gov Identifier: NCT00244101     History of Changes
Other Study ID Numbers: CHRMS 03-233
Study First Received: October 24, 2005
Results First Received: August 16, 2012
Last Updated: August 16, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Vermont Oxford Network:
Prematurity
respiratory distress syndrome
surfactant
nasal continuous positive airway pressure

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Pulmonary Surfactants
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014