Synchronized Intermittent Mandatory Ventilation (SIMV) Versus Nasal Intermittent Positive Pressure Ventilation (NIPPV) In Preterm Infants With Respiratory Distress
This study has been completed.
Sponsor:
University of Southern California
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
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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:
Genetic and Rare Diseases Information Center resources:
Respiratory Distress Syndrome, Infant
Acute Respiratory Distress Syndrome
U.S. FDA Resources
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
- NIPPV
- SIMV
Comparison of extubation to NIPPV versus NCPAP
Other Names:
Show Detailed Description
Eligibility| Ages Eligible for Study: | up to 120 Minutes (Child) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Estimated gestational age 26 to 29 + 6 weeks inclusive;
- Inborn;
- Birth Weight: ≥ 600 grams;
- Required endotracheal intubation for respiratory distress;
- Has received one dose of poractant alfa 200mg/kg within 60 minutes of birth;
- No known lethal congenital anomaly or genetic syndromes;
- No known lung maturity; and
- Signed parental informed consent
Exclusion Criteria:
- Gestational age < 26 weeks or ≥ 30 weeks;
- Birth weight less than 600 grams;
- Apgar score of 0 at one minute of age; and
- 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
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
| 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 Respiratory Distress Syndrome, Adult Lung Diseases Respiratory Tract Diseases |
Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases |
ClinicalTrials.gov processed this record on September 28, 2016