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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by University of Manitoba
Sponsor:
Information provided by (Responsible Party):
Dr. Yaser Ali, University of Manitoba
ClinicalTrials.gov Identifier:
NCT01942967
First received: July 19, 2013
Last updated: October 14, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Respiratory Distress Syndrome
Other: Echocardiography
Other: Near Infrared Spectroscopy Monitoring

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Change in cardiac output [ Time Frame: Day 3 of life till 2 months of age ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]
  • Cerebral and mesenteric regional tissue oxygenation [ Time Frame: Day 3 of life till 2 months of age ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 20
Study Start Date: August 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Other: Echocardiography

Measurement of:

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

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.

  Eligibility

Ages Eligible for Study:   up to 2 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Newborn infants less than 34 weeks gestational age at birth Requiring CPAP or TrPA as a mode of respiratory support

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01942967

Contacts
Contact: Yaser Ali, MD 1 204 787 4218 yali@hsc.mb.ca
Contact: Yasser Elsayed, MD 1 204 787 1825 yelsayed@hsc.mb.ca

Locations
Canada, Manitoba
Health Sciences Center Recruiting
Winnipeg, Manitoba, Canada, R3A 1S1
Contact: Yaser Ali       yali@hsc.mb.ca   
Principal Investigator: Yaser Ali, MD         
St. Boniface General Hospital Recruiting
Winnipeg, Manitoba, Canada, R2H 2A6
Contact: Yaser Ali, MD       yali@hsc.mb.ca   
Sponsors and Collaborators
University of Manitoba
Investigators
Study Director: Ganesh Srinivasan, MD University of Manitoba
Study Director: Mary S Seshia, MD University of Manitoba
  More Information

No publications provided

Responsible Party: Dr. Yaser Ali, Fellow, Perinatal-Neonatal Medicine, University of Manitoba
ClinicalTrials.gov Identifier: NCT01942967     History of Changes
Other Study ID Numbers: B2013: 055
Study First Received: July 19, 2013
Last Updated: October 14, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Manitoba:
Neonate
Hemodynamic
Tissue oxygenation
Non invasive ventilation

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on July 28, 2014