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

• ClinicalTrials.gov Identifier: NCT00486850
• Recruitment Status: Completed
• First Posted: June 15, 2007
• Last Update Posted: July 10, 2009
• Sponsor: University of Southern California
• Collaborator: Dey, L.P., Napa Valley, Califonia
• Information provided by: University of Southern California

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Respiratory Distress Syndrome, Newborn	Other: Extubation to Nasal IPPV	Phase 4

  Show Detailed Description

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 110 participants
• 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
• Study Start Date: October 2006
• Actual Primary Completion Date: November 2008
• Actual Study Completion Date: January 2009

Arms and Interventions

Intervention Details:

• Other: Extubation to Nasal IPPV
  Comparison of extubation to NIPPV versus NCPAP
  Other Names:

  • NIPPV
  • SIMV

Outcome Measures

Primary Outcome Measures :

1. Incidence of Mechanical Ventilation via endotracheal tube at 7 days of age [ Time Frame: At 7 days of age ]

Secondary Outcome Measures :

1. 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 ]

Eligibility Criteria

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

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 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