Comparing breathing support methods for preterm infants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to measure and compare diaphragm electrical activity in very low birth weight preterm infants requiring breathing support through either Continuous Positive Airway Pressure (CPAP) or Non-Invasive Positive Pressure Ventilation (NIPPV). The infants will be assigned to receive each method for two hours in a controlled setting, allowing researchers to monitor their respiratory function and stability. The study will involve routine monitoring of vital signs and will take place in the Neonatal Intensive Care Unit (NICU) at Sunnybrook Health Sciences Centre.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Clinically stable preterm infants (defined as cardiovascular stability with normal blood pressure and heart rate for gestational age and no recent increase in apneic episodes or spells and confirmed by the attending neonatologist)
* Birth weight less than 1500 grams
* Admitted to the NICU at Sunnybrook Health Sciences Centre on nasal CPAP of 5 to 8 cmH2O support, for at least 48 hours and requiring less than 35% of oxygen

Exclusion Criteria:

* Congenital anomalies of the gastrointestinal tract
* Phrenic nerve damage
* Diaphragmatic paralysis
* Esophageal perforation
* Congenital or acquired neurological deficit (including significant intraventricular hemorrhage greater than Grade II) or neonatal seizure
* Significant congenital heart disease (including symptomatic PDA)
* Congenital anomalies of the diaphragm
* Congenital anomalies of the respiratory tracts (e.g., Congenital Cystic Adenomatoid Malformation 'CCAM')
* Ongoing treatment for sepsis
* Ongoing treatment for necrotizing enterocolitis (NEC)
* Ongoing treatment for lung infections
* Narcotic analgesics
* Gastric motility agents
* Infants on nasal CPAP and requiring more than 35% oxygen
* Infants with significant gastric residuals and vomiting
* Infants with facial anomalies
* Infants with pneumothorax or pneumomediastinum
* Infants in the immediate postoperative period

Where it's running

• Sunnybrook Health Sciences Center
  Toronto, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Maher Shahroor, MD
• Email: maher.shahroor@sunnybrook.ca
• Phone: (416) 480-6100

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.