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Compares treatment options for Preterm Birth
Official title Effect of Nasal CPAP Versus NIPPV On Diaphragm Electrical Activity (Edi) In VLBW Preterm Infants
ClinicalTrials.gov ID: NCT06295484
What this study is testing
- What it's testing
- Background: In premature babies, many organ systems are not fully grown and developed, including the lungs and respiratory muscles, so they will need breathing support to help them to breathe by preventing their tiny air sacs to collapse. This support commonly done by CPAP and Non-Invasive Positive Pressure Ventilation (NIPPV) therapy by giving some pressure and oxygen to their lungs through an interface placed on their noses.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 8
You may be able to join if
- Clinically stable preterm infants (defined as cardiovascular stability with normal blood pressure and heart rate for gestational age and no recent...
- 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...
You likely can't join if
- 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)
See the full eligibility 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 day to 8 months. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.