Synchronized Intermittent Mandatory Ventilation (SIMV) Versus Nasal Intermittent Positive Pressure Ventilation (NIPPV) In Preterm Infants With Respiratory Distress

This study has been completed.
Sponsor:
Collaborator:
Dey, L.P., Napa Valley, Califonia
Information provided by:
University of Southern California
ClinicalTrials.gov Identifier:
NCT00486850
First received: June 13, 2007
Last updated: July 9, 2009
Last verified: February 2009
  Purpose

Title of Study: A Prospective, Randomized, Multicenter Trial Comparing Synchronized Intermittent Mandatory Ventilation (SIMV) vs. Early Extubation to Nasal Intermittent Positive Pressure Ventilation (NIPPV) after Surfactant Treatment in Preterm Infants with Respiratory Distress Treatment Period (Planned): 7 days Objectives: To compare the impact of early extubation [within 120 minutes of birth to Nasal Intermittent Positive Pressure Ventilation (NIPPV group) vs. Synchronized Intermittent Mandatory Ventilation (SIMV group) on the incidence of mechanical ventilation via endotracheal tube at 7 days of age in 26 to 29 + 6 weeks gestation premature infants with respiratory distress treated with intratracheal Curosurf (poractant alpha) within 60 minutes of birth.

Secondary objectives include evaluation of overall clinical outcomes at 7 days, 28 days, and 36 weeks postmenstrual age (PMA) and/or at discharge, complications, safety, and adverse events.

Number of Subjects: 110


Condition Intervention Phase
Respiratory Distress Syndrome, Newborn
Other: Extubation to Nasal IPPV
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Synchronized Intermittent Mandatory Ventilation (SIMV) Versus Nasal Intermittent Positive Pressure Ventilation (NIPPV) In Preterm Infants With Respiratory Distress

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • Incidence of Mechanical Ventilation via endotracheal tube at 7 days of age [ Time Frame: At 7 days of age ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall clinical outcomes at 7 days, 28 days, and 36 weeks postmenstrual age [ Time Frame: At 7 days, 28 days and at 36 weeks postmenstraul age ] [ Designated as safety issue: No ]

Enrollment: 110
Study Start Date: October 2006
Study Completion Date: January 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Extubation to Nasal IPPV
    Comparison of extubation to NIPPV versus NCPAP
    Other Names:
    • NIPPV
    • SIMV
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 120 Minutes
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Estimated gestational age 26 to 29 + 6 weeks inclusive;
  2. Inborn;
  3. Birth Weight: ≥ 600 grams;
  4. Required endotracheal intubation for respiratory distress;
  5. Has received one dose of poractant alfa 200mg/kg within 60 minutes of birth;
  6. No known lethal congenital anomaly or genetic syndromes;
  7. No known lung maturity; and
  8. Signed parental informed consent

Exclusion Criteria:

  1. Gestational age < 26 weeks or ≥ 30 weeks;
  2. Birth weight less than 600 grams;
  3. Apgar score of 0 at one minute of age; and
  4. Lethal congenital anomaly or genetic syndrome identified antenatally or within 60 minutes of birth
  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: NCT00486850

Locations
United States, California
Women's and Children's Hospital, Room l-919, 1240, N.Mission Road
Los Angeles, California, United States, 90033
Sharp Mary Birch Hospital for Women
San Diego, California, United States, 62123
United States, Georgia
Medical College of Georgia
Augusta, Georgia, United States, 30912
United States, Oklahoma
Children's Hospital, OUMC
Oklahoma, Oklahoma, United States, 73190
Sponsors and Collaborators
University of Southern California
Dey, L.P., Napa Valley, Califonia
Investigators
Principal Investigator: Rangasamy Ramanathan, MD University of Southern California
  More Information

No publications provided

Responsible Party: Rangasamy Ramanathan, MD., University of Southern California
ClinicalTrials.gov Identifier: NCT00486850     History of Changes
Other Study ID Numbers: SIMV versus NIPPV Trial
Study First Received: June 13, 2007
Last Updated: July 9, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Southern California:
RDS
Preterm
SIMV
NIPPV

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on September 18, 2014