Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Preterm babies have immature lungs and frequent pauses in their breathing which often necessitates breathing support. Nasal Continuous Positive Airway Pressure (nCPAP) is one of the most commonly used tools, but the standard interfaces (prongs or mask) may cause nasal-septal injury and discomfort.
The RAM cannula is another interface that consists in soft and curved prongs to avoid this nasal injury, but as the seal is not 100%, suboptimal delivery of airway distending pressure could result if they are used to deliver CPAP, as compared to standard interfaces.
The investigators plan to study very low birth weight preterm babies who are generally well but require some support with their breathing. By inserting a special feeding tube with sensors into the stomach, the investigators can measure the electrical activity of the diaphragm (EAdi), which is an important muscle for breathing. By analyzing EAdi in babies receiving nCPAP either with prongs or ram cannula, the investigators will be able to measure and compare how each method of support affects a baby's breathing. This important study will help us determine the most appropriate breathing support for preterm babies.
Continuous Positive Airway Pressure is one of the most researched and accepted methods of delivering NIV to term and preterm infants. Different interfaces have been used, most frequently binasal prongs or mask. The RAM cannula is a relatively new interface for delivering CPAP in preterm infants, specially to avoid nasal injury and discomfort. However, there are few studies in artificial models with different results in term of the percentage of pressure that is really delivered when we use the RAM cannula. The objective of this study is to to investigate in VLBW preterm infants who require respiratory support by nasal CPAP, whether or not using the RAM cannula as the interface will allow to provide the level of respiratory support equivalent to that with the traditional binasal prongs, measured by diaphragm electrical activity (Edi). The investigators hypothesize that in VLBW preterm infants with respiratory distress syndrome (RDS), the use of CPAP with RAM cannula as the interface may provide lower PEEP (positive end expiratory pressure) than set and increased resistance to gas flow, leading to increased respiratory effort for the patient as reflected by an increase in Edi.
This study will help Neonatologist determine if the amount of support provided with the RAM cannula as interface is equivalent to the support we achieve with the standard interfaces, to select the patients that could benefit from using this interface. The investigators will be able to utilize this information to decide on the most appropriate respiratory support modality for preterm patients.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPAP with binasal prongs | Active Comparator | Edi will be recorded while the infant is on nasal CPAP with the binasal prongs, with a PEEP of 5-8 cm H2O, for 2 hours. Then, the infant will be switched the interface to the RAM cannula, with a PEEP 2 cmH2O higher, during 2 hours. |
|
| CPAP with RAM cannula | Active Comparator | Edi will be recorded while the infant is on nasal CPAP with the RAM cannula with a PEEP 2 cmH20 higher than the levels the infant was receiving before starting the study protocol, for 2 hours. Then, the infant will be switched the interface to the binasal prongs with a PEEP between 5-8 cmH2O, during 2 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| respiratory support- interface | Other | change interface to RAM cannula |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in Edi min between CPAP with binasal prongs versus with the RAM cannula | Measured by the electrical activity of the diaphragm between respiratory support modes (nCPAP with binasal prongs and RAM cannula) | 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in neural respiratory rate | Measured by the electrical activity of the diaphragm between respiratory support modes (nCPAP with binasal prongs and RAM cannula). | 4 hours |
| Difference in neural inspiratory time |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Dunn, MD | Contact | (416) 480-6100 | 87777 | michael.dunn@sunnybrook.ca |
| Carolina Lopez-Sanguos, MD | Contact | 6479265754 | caro_ls4@msn.com |
| Name | Affiliation | Role |
|---|---|---|
| Michael Dunn, MD | Staff Neonatologist - NICU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunnybrook Health Science Centre | Recruiting | Toronto | Ontario | M4N3M5 | Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Randomization will be done by sealed envelopes, ready for use once consent is obtained.Each envelope will contain a card with the assigned treatment group: protocol 1 or protocol 2.
Protocol 1: we start the study on CPAP with binasal prongs. Edi will be recorded while the infant is on nasal CPAP with the binasal prongs, with a PEEP of 5-8 cm H2O, for 2 hours. Then, the infant will be switched the interface to the RAM cannula, with a PEEP 2 cmH2O higher, during 2 hours.
Protocol 2: we start the study on CPAP with RAM cannula. Edi will be recorded while the infant is on nasal CPAP with the RAM cannula with a PEEP 2 cmH20 higher than the levels the infant was receiving before starting the study protocol, for 2 hours. Then, the infant will be switched the interface to the binasal prongs with a PEEP between 5-8 cmH2O, during 2 hours.
Not provided
Not provided
Not provided
Not provided
| respiratory support- interface |
| Other |
change interface to binasal prongs |
|
Measured by the electrical activity of the diaphragm between respiratory support modes (nCPAP with binasal prongs and RAM cannula).
| 4 hours |
| Difference in Edi peak | Measured by the electrical activity of the diaphragm between respiratory support modes (nCPAP with binasal prongs and RAM cannula). | 4 hours |
| Difference in transcutaneous pCO2 | Measured difference in transcutaneous pCO2 between the 2 different respiratory support modes(nCPAP with binasal prongs and RAM cannula). | 4 hours |
| Difference in number of apnea episodes | Difference in number of apnea episodes between the 2 different respiratory support modes (nCPAP with binasal prongs and RAM cannula). | 4 hours |
| Needs of oxygen | Needs of O2 measured by FiO2 on the 2 different respiratory support modes (nCPAP with binasal prongs and RAM cannula). | 4 hours |
| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
Not provided
Not provided