Respiratory Distress Syndrome Clinical Trial
Official title:
Impact of Different Modes of Noninvasive Ventilation (NCPAP Versus TrPA) on Regional Cerebral and Splanchnic Oximetry as Measured by Near Infrared Spectroscopy (NIRS) and Hemodynamics Using Echocardiography in Premature Newborns
The purpose of this study is to examine the blood flow and the delivery of oxygen to the brain and gut in preterm babies while they are supported with two modes of breathing machine and compare these two methods to see if one allows for better blood flow to the brain and gut.
Preterm babies under 32 weeks of gestational age usually needs to be supported with
breathing machine because of different kinds of problems like lungs immaturity or infection.
One type of breathing machine support is called CPAP(Continuous Positive Airway
Pressure).This breathing support machine is connected to the nose to help preterm baby
breathe. This machine blows air or an air/oxygen mixture through the nose and in to the
baby's lung; this helps to keep baby's lungs fully open and makes it easier for the baby to
breathe. There are two ways this machine can help the baby breathe - it can either blow the
air/oxygen mixture at the same pressure all the time…we call that CPAP, or we can vary the
pressure - we call that TrPA(Trigger Pressure Assist). Both methods have been in use in
neonatal intensive care units(NICUs) for several years and both methods help with the
breathing of babies.
The breathing machine (CPAP) makes the lungs better inflated. This inflation might affect
the ability of the heart to push the blood to the organs through the blood vessels. Also we
do not know whether there is any difference in the blood flow or oxygen delivery depending
whether the baby is on CPAP or TrPA.
We will measure the heart function using Ultrasound (Echocardiography). To measure the
efficiency of the flow of the blood through the vessels to the organs we will use Near Infra
Red Spectroscopy (NIRS); this involves applying a sensor to the baby's skin - one on the
forehead and one on the tummy and connecting the sensors to a machine which can measure the
oxygen level in the organ under the skin.
While the baby is on CPAP, we will start monitoring oxygen saturation by applying NIRS
sensors to the forehead and the abdomen. After 3 hours we will do echocardiography
(ultrasound of the heart)to see any changes that might happen to the heart and blood vessels
while the baby is on CPAP. Then, using the same machine, we will change the mode of
respiratory support to TrPA. After another three hours, we will do another echocardiography
(ultrasound of the heart), then we will stop NIRS monitoring and change the mode of
respiratory support back to CPAP.
;
Observational Model: Case-Crossover, Time Perspective: Prospective
| 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 |