Synchronized Intermittent Mandatory Ventilation (SIMV) Versus Nasal Intermittent Positive Pressure Ventilation (NIPPV) In Preterm Infants With Respiratory Distress
Completed · Phase 4
Conditions studied: Respiratory Distress Syndrome, Newborn
In brief
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
Key facts
- Study ID
- NCT00486850
- Run by
- University of Southern California
- People needed
- 110
- Starts
- 2006-10-01
- Expected to finish
- 2009-01-01
- Last updated by the study team
- 2009-07-10
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Women's and Children's Hospital, Room l-919, 1240, N.Mission Road — Los Angeles, California, United States
- Sharp Mary Birch Hospital for Women — San Diego, California, United States
- Medical College of Georgia — Augusta, Georgia, United States
- Children's Hospital, OUMC — Oklahoma City, Oklahoma, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.