Synchronized Intermittent Mandatory Ventilation (SIMV) Versus Nasal Intermittent Positive Pressure Ventilation (NIPPV) In Preterm Infants With Respiratory Distress
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 110
- Locations
- 8
- Primary Endpoint
- Incidence of Mechanical Ventilation via endotracheal tube at 7 days of age
Study Overview
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
Detailed Description
Respiratory management: SIMV group:
Infants randomized to SIMV will be maintained on SIMV per standard unit protocol. Infant can be progressively weaned and extubated to NCPAP if infant meets the minimum criteria for extubation. Caffeine will be administered around the time of extubation.
NIPPV group:
Extubated to NIPPV within 120 minutes of birth if the fraction of inspired oxygen (FiO2) is less than 0.60 after the first dose of surfactant. Caffeine will be administered around the time of extubation. Infant can be reintubated if clinical parameters necessitate mechanical ventilation. NIPPV may be discontinued when patients are weaned to a positive end expiratory pressure of 5 cmsH20 with back up rate <10 bpm and FiO2 <0.30 for 24 hours to nasal continuous positive airway pressure (NCPAP).
Surfactant administration:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 10 Minutes to 120 Minutes (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Estimated gestational age 26 to 29 + 6 weeks inclusive;
- •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
Outcomes
Primary Outcomes
Incidence of Mechanical Ventilation via endotracheal tube at 7 days of age
Time Frame: At 7 days of age
Secondary Outcomes
- Overall clinical outcomes at 7 days, 28 days, and 36 weeks postmenstrual age(At 7 days, 28 days and at 36 weeks postmenstraul age)