Respiratory Distress Syndrome Clinical Trial
Official title:
Effect of Nasal Continuous Positive Airway Pressure (nCPAP) With RAM Cannula Versus Standard Binasal Prongs on Diaphragm Electrical Activity in Very Low Birth Weight (VLBW) Preterm Infants
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT06168149 -
The Relationship of Fetal Lung Elastography Values With the Development of Respiratory Distress in Cases of Preterm Labor
|
||
Recruiting |
NCT03670732 -
CPAP vs.Unsynchronized NIPPV at Equal Mean Airway Pressure
|
N/A | |
Recruiting |
NCT02901652 -
NIPPV and nBiPAP Methods in Preterm Infants With Respiratory Distress Syndrome
|
N/A | |
Completed |
NCT02249143 -
Duration of Continuous Positive Airway Pressure and Pulmonary Function Testing in Preterm Infants
|
N/A | |
Suspended |
NCT01852916 -
NHFOV Versus NCPAP to Prevent Exubation Failure
|
N/A | |
Completed |
NCT00208039 -
Pilot Trial of Surfactant Booster Prophylaxis For Ventilated Preterm Neonates
|
N/A | |
Recruiting |
NCT03510169 -
Use of Gentle Synchronized Negative Pressure in Helping Babies Breathe
|
N/A | |
Completed |
NCT00004494 -
Phase I Study of Vasoactive Intestinal Peptide in Patients With Acute Respiratory Distress Syndrome and Sepsis
|
Phase 1 | |
Completed |
NCT00006058 -
Study of the Pathobiology of Bronchopulmonary Dysplasia in Newborns
|
N/A | |
Completed |
NCT00004805 -
Study of the Effect of Four Methods of Cardiopulmonary Resuscitation Instruction on Psychosocial Response of Parents With Infants at Risk of Sudden Death
|
N/A | |
Completed |
NCT03292562 -
A Comparison of Methods of Discontinuing Nasal CPAP in Premature Infants <30 Weeks Gestation
|
N/A | |
Completed |
NCT05948332 -
Definition and Management of Right Ventricular Injury in Adult Patients Receiving Extracorporeal Membrane Oxygenation
|
||
Completed |
NCT05038514 -
The Effect of Music Therapy in COVID-19 Patients Given Prone Position
|
N/A | |
Active, not recruiting |
NCT04079829 -
Postoperative Respiratory Abnormalities
|
||
Completed |
NCT05462509 -
Feasibility of Use of the PATH bCPAP and Oxygen Blenders Device With Neonates in Uganda
|
N/A | |
Active, not recruiting |
NCT03808402 -
The Effect of Surfactant Dose on Outcomes in Preterm Infants With RDS
|
||
Completed |
NCT01812681 -
Cord Blood 25(oh)-Vitamin D Level in Preterm Infants and Associated Morbidities
|
N/A | |
Completed |
NCT01517958 -
Lung Ultrasound to Diagnose Transient Tachypnea of the Newborn (TTN) Versus Respiratory Distress Syndrome (RDS) in Neonates
|
N/A | |
Not yet recruiting |
NCT01440868 -
Sustained Lung Inflation in the Delivery Room in Preterm Infants at High Risk of Respiratory Distress Syndrome
|
N/A | |
Completed |
NCT01222247 -
Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial
|
Phase 3 |