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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00486850

First Posted: June 15, 2007

Last Update Posted: July 10, 2009

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

Dey, L.P., Napa Valley, Califonia

Information provided by:

University of Southern California

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 Intervention Model: Single Group Assignment Masking: None (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 ]

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 ]


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:

Comparison of extubation to NIPPV versus NCPAP

Other Names:

NIPPV
SIMV

Show Detailed Description

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	up to 120 Minutes (Child)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted:	June 13, 2007
First Posted:	June 15, 2007
Last Update Posted:	July 10, 2009
Last Verified:	February 2009

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

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