Effect of Nasal Continuous Positive Airway Pressure (nCPAP) Versus Non-Invasive Positive Pressure Ventilation (NIPPV) On Diaphragm Electrical Activity (Edi) In Very Low Birth Weight (VLBW) Preterm Infants

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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. Both (CPAP and NIPPV) can be used as a support modality for respiratory distress syndrome, apnea of prematurity, and providing breathing support after extubation from the full mechanical breathing support. The CPAP supports the baby's immature lungs by delivering constant pressure to keep their lungs and breathing well supported. Whereas the NIPPV will use constant pressure in the background (similar to CPAP), and on top, it will give extra intermittent puffs at regular intervals to support the baby's breathing. The NIPPV is the most common choice by the clinicians when the traditional CPAP is no longer effective, to avoid the full mechanical breathing support and to protect the developing lungs. Studies suggested that NIPPV is better than the traditional CPAP in reducing the need of the baby to need full mechanical breathing support. This might be because the investigators tend to use lower pressures with CPAP (5-8 cmH2O) compared to relatively higher pressures with NIPPV. More recently, clinicians showed the safety of using equivalent higher CPAP pressures (\>9 cmH2O) to what the investigators use in the NIPPV in preterm babies. One way to measure the support that the investigators are giving to the patient with the different devices is to measure the diaphragm activity, which the investigators call the Edi signal, using a special feeding catheter and a specific machine to measure it. The catheter is placed and used as a routine feeding tube but has sensors at the end to measure this Edi signal. One opening of the tube will be connected to a computer to record the Edi signals. The other opening of the tube will be used for feeding.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 day
Maximum Age: 8 months
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
Sunnybrook Health Sciences Center
RECRUITING
Toronto
Contact Information
Primary
Maher Shahroor, MD
maher.shahroor@sunnybrook.ca
(416) 480-6100
Time Frame
Start Date: 2021-08-21
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 24
Treatments
Other: Traditional CPAP, then NIPPV, then high CPAP.
The participant will stay for 2 hours on Traditional CPAP, then 2 hours on NIPPV, then 2 hours on high CPAP. The investigators will continue to record the Edi signals during the 3 methods.
Other: Traditional CPAP, then high CPAP, then NIPPV
The participant will stay for 2 hours on Traditional CPAP, then 2 hours on high CPAP, then 2 hours on NIPPV. The investigators will continue to record the Edi signals during the 3 methods.
Other: NIPPV, then traditional CPAP, then high CPAP
The participant will stay for 2 hours on NIPPV, then 2 hours on traditional CPAP, then 2 hours on high CPAP. The investigators will continue to record the Edi signals during the 3 methods.
Other: NIPPV, then high CPAP, then traditional CPAP.
The participant will stay for 2 hours on NIPPV, then 2 hours on high CPAP, then 2 hours on traditional CPAP. The investigators will continue to record the Edi signals during the 3 methods.
Other: High CPAP, then traditional CPAP, then NIPPV.
The participant will stay for 2 hours on High CPAP, then 2 hours on traditional CPAP, then 2 hours on NIPPV. The investigators will continue to record the Edi signals during the 3 methods.
Other: High CPAP, then NIPPV, then traditional CPAP.
The participant will stay for 2 hours on High CPAP, then 2 hours on NIPPV, then 2 hours on traditional CPAP. The investigators will continue to record the Edi signals during the 3 methods.
Sponsors
Leads: Sunnybrook Health Sciences Centre

This content was sourced from clinicaltrials.gov

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