Actively Recruiting
Effect of Nasal Continuous Positive Airway Pressure Versus Non-Invasive Positive Pressure Ventilation on Diaphragm Electrical Activity in Very Low Birth Weight Preterm Infants
Led by Sunnybrook Health Sciences Centre · Updated on 2024-03-06
24
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Premature babies often have underdeveloped lungs and respiratory muscles, requiring breathing support to prevent lung collapse and assist breathing. This trial compares two types of breathing support for very low birth weight (VLBW) preterm infants: traditional nasal Continuous Positive Airway Pressure (CPAP) and Non-Invasive Positive Pressure Ventilation (NIPPV). The goal is to measure the electrical activity of the diaphragm (Edi) to better understand how these supports affect the baby's breathing effort. Participants will receive three types of breathing support in varying sequences: traditional CPAP, NIPPV, and high-pressure CPAP. Each support method is applied for 2 hours, totaling 6 hours of monitoring. A special feeding tube with sensors will measure the diaphragm's electrical activity during each method, while routine monitoring of oxygen saturation, heart rate, and respiratory rate continues. Throughout the study, babies will be closely observed while the Edi signals are recorded. After completing the 6-hour protocol, babies will return to their originally prescribed breathing support. Researchers will analyze differences in diaphragm activity and other respiratory measures to compare the effects of the three support methods. The study is conducted in a neonatal intensive care unit and involves stable preterm infants born weighing less than 1500 grams.
CONDITIONS
Brief Title
Effect of Nasal CPAP Versus NIPPV On Diaphragm Electrical Activity (Edi) In VLBW Preterm Infants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinically stable preterm infants with normal blood pressure and heart rate for gestational age
- Birth weight less than 1500 grams
- Admitted to the NICU on nasal CPAP of 5 to 8 cmH2O for at least 48 hours
- Require less than 35% oxygen support
You will not qualify if you...
- Congenital anomalies of the gastrointestinal tract
- Phrenic nerve damage
- Diaphragmatic paralysis
- Esophageal perforation
- Congenital or acquired neurological deficits including significant intraventricular hemorrhage greater than Grade II or neonatal seizure
- Significant congenital heart disease including symptomatic PDA
- Congenital anomalies of the diaphragm or respiratory tract such as CCAM
- Ongoing treatment for sepsis, necrotizing enterocolitis, or lung infections
- Use of narcotic analgesics or gastric motility agents
- Infants requiring more than 35% oxygen on nasal CPAP
- Significant gastric residuals and vomiting
- Facial anomalies
- Pneumothorax or pneumomediastinum
- Immediate postoperative period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 hours
Participants will experience three different breathing support methods: traditional CPAP, NIPPV, and high CPAP. Each method will be used for 2 hours while electrical activity of the diaphragm (Edi) is recorded.
1 continuous monitoring period during the 6-hour treatment
Trial Site Locations
Total: 1 location
1
Sunnybrook Health Sciences Center
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
Research Team
M
Maher Shahroor, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
6
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