Impact of Different Modes of Noninvasive Ventilation on Regional Oximetry and Hemodynamics in Premature Newborn

NCT ID: NCT01942967

Last Updated: 2015-08-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2014-08-31

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.

Conditions

Respiratory Distress Syndrome

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: PROSPECTIVE

Study Groups

Preterm ≤ 32 weeks GA, on CPAP

Preterm infants less than 32 weeks gestational age requiring CPAP as a mode of respiratory support and admitted in the NICU.While the baby is on CPAP,tissue oxygen saturation monitoring will be started by applying NIRS(Near Infrared Spectroscopy Monitoring) sensors to the forehead and the abdomen. After 3 hours,echocardiography(including Superior Mesenteric Artery Doppler) will be done while the baby is on CPAP. Then, using the same machine, the mode of respiratory support will be changed to TrPA. After another three hours,another echocardiography will be done,then NIRS monitoring will be stopped and the mode of respiratory support will be changed back to CPAP.

Echocardiography

Intervention Type: OTHER

Measurement of:

• Left ventricular output (LVO).
• Right ventricular output (RVO).
• Assessment of the Mesenteric Artery Flow.

Near Infrared Spectroscopy Monitoring

Intervention Type: OTHER

Measurement of cerebral and mesenteric regional oxygen saturation(rSO2) trends and data while the baby on CPAP or TrPA modes of noninvasive ventilation.

Interventions

Echocardiography

Measurement of:

• Left ventricular output (LVO).
• Right ventricular output (RVO).
• Assessment of the Mesenteric Artery Flow.

Intervention Type: OTHER

Near Infrared Spectroscopy Monitoring

Measurement of cerebral and mesenteric regional oxygen saturation(rSO2) trends and data while the baby on CPAP or TrPA modes of noninvasive ventilation.

Intervention Type: OTHER

Other Intervention Names

NIRS

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

• Minimum Eligible Age: 48 Hours
• Maximum Eligible Age: 2 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Dr. Yaser Ali

Fellow, Perinatal-Neonatal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ganesh Srinivasan, MD

Role: STUDY_DIRECTOR

University of Manitoba

Mary S Seshia, MD

Role: STUDY_DIRECTOR

University of Manitoba

Locations

St. Boniface General Hospital

Winnipeg, Manitoba, Canada

Health Sciences Center

Winnipeg, Manitoba, Canada

Countries

Canada

Other Identifiers

B2013: 055

Identifier Type: -

Identifier Source: org_study_id