Skip to main content
Clinical Trials/NCT01942967
NCT01942967
Completed
Not Applicable

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

University of Manitoba2 sites in 1 country10 target enrollmentAugust 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Respiratory Distress Syndrome
Sponsor
University of Manitoba
Enrollment
10
Locations
2
Primary Endpoint
Change in cardiac output
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
August 2013
End Date
August 2014
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Yaser Ali

Fellow, Perinatal-Neonatal Medicine

University of Manitoba

Eligibility Criteria

Inclusion Criteria

  • Preterm infants less than 34 weeks gestational age
  • Requirement of CPAP or TrPA as a mode of respiratory support

Exclusion Criteria

  • Lack of parental consent
  • Preterm infants more than 34 gestational weeks
  • Preterm infants with congenital malformation
  • Severe perinatal asphyxia
  • Hemodynamically significant patent ductus arteriosus (PDA)
  • Pulmonary hypertension
  • Septic shock
  • Any associated congenital heart diseases other than non-significant PDA or patent foramen ovale (PFO)
  • Stage 2 or 3 necrotising enterocolitis (NEC)
  • Intraventricular hemorrhage (IVH) grade 3 or 4

Outcomes

Primary Outcomes

Change in cardiac output

Time Frame: Day 3 of life till 2 months of age

Targeted neonatal Echocardiography will be done according to the guidelines accepted by the writing group of the American society of echocardiography in collaboration with associations of European pediatric cardiologists The following standard windows will be used: 1. Subcostal. 2. Apical. 3. Long and short axis parasternal. 4. Suprasternal Measurements: * Left ventricular output (LVO). * Right ventricular output (RVO).

Changes in Superior Mesenteric Artery and Middle Cerebral Artery Doppler flow.

Time Frame: Day 3 of life till 2 months of age

Cerebral and mesenteric regional tissue oxygenation

Time Frame: Day 3 of life till 2 months of age

Cerebral and mesenteric rSO2 trends and data (obtained by NIRS) will be recorded along with simultaneous pulse oximeter trends and data. The splanchnic-cerebral oxygenation ratio (SCOR) reflecting the ratio between regional cerebral oxygen saturation(rcSO2) and regional splanchnic oxygen saturation (rsSO2)(rcSO2/rsSO2) will be analyzed.

Study Sites (2)

Loading locations...

Similar Trials