Respiratory Distress SyndromeNCT01942967
Impact of Different Modes of Noninvasive Ventilation on Regional Oximetry and Hemodynamics in Premature Newborn
An observational study of Respiratory Distress Syndrome, run by University of Manitoba at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 48 hours to 2 months
- Conditions the study is for
- Respiratory Distress Syndrome
- What is being tested?
- Echocardiography and Near Infrared Spectroscopy Monitoring
- How many people
- 10 participants
- Where
- 2 sitesCanada
- Study dates
- Aug 2013to Aug 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 48 hours to 2 months
- All sexes
- No healthy volunteers
- Child
Study population: Newborn infants less than 34 weeks gestational age at birth Requiring CPAP or TrPA as a mode of respiratory support
Who may be able to join
- Preterm infants less than 34 weeks gestational age
- Requirement of CPAP or TrPA as a mode of respiratory support
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
St. Boniface General Hospital
Winnipeg, Manitoba, R2H 2A6
Health Sciences Center
Winnipeg, Manitoba, R3A 1S1
About this study
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.
Read the 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
- Being tested
- Echocardiography, Near Infrared Spectroscopy Monitoring
- Keywords
- Neonate, Hemodynamic, Tissue oxygenation, Non invasive ventilation
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyOther
Measurement of:
- Left ventricular output (LVO).
- Right ventricular output (RVO).
- Assessment of the Mesenteric Artery Flow.
Near Infrared Spectroscopy MonitoringOther
Also called NIRS
Measurement of cerebral and mesenteric regional oxygen saturation(rSO2) trends and data while the baby on CPAP or TrPA modes of noninvasive ventilation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Echocardiography; Other: Near Infrared Spectroscopy Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cardiac output
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:
- Subcostal.
- Apical.
- Long and short axis parasternal.
- Suprasternal
Measurements:
- Left ventricular output (LVO).
- Right ventricular output (RVO).
Measured: Day 3 of life till 2 months of age
Changes in Superior Mesenteric Artery and Middle Cerebral Artery Doppler flow.
Measured: Day 3 of life till 2 months of age
Cerebral and mesenteric regional tissue oxygenation
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.
Measured: Day 3 of life till 2 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2013 (estimated)
- Study startAug 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Yaser Ali, University of Manitoba
- Investigators
- Ganesh Srinivasan, MD, Study director, University of ManitobaMary S Seshia, MD, Study director, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01942967
- Sponsor's protocol ID
- B2013: 055
- Status last verified
- Aug 2015
- First submitted
- 19 Jul 2013
- Last updated
- 4 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01942967
- Acronym / sponsor ID
- B2013: 055
- Conditions
- Respiratory Distress Syndrome
- Keywords
- Neonate, Hemodynamic, Tissue oxygenation, Non invasive ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 16 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preterm ≤ 32 weeks GA, on CPAP | – | Other: Echocardiography, Other: Near Infrared Spectroscopy MonitoringPreterm 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. |
Who may qualify
- Ages
- 48 hours to 2 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Newborn infants less than 34 weeks gestational age at birth Requiring CPAP or TrPA as a mode of respiratory support
Key inclusion criteria (2 listed)
- Preterm infants less than 34 weeks gestational age
- Requirement of CPAP or TrPA as a mode of respiratory support
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EchocardiographyMeasurement of: * Left ventricular output (LVO). * Right ventricular output (RVO). * Assessment of the Mesenteric Artery Flow. | Other | Preterm ≤ 32 weeks GA, on CPAP |
| Near Infrared Spectroscopy MonitoringAlso: NIRSMeasurement of cerebral and mesenteric regional oxygen saturation(rSO2) trends and data while the baby on CPAP or TrPA modes of noninvasive ventilation. | Other | Preterm ≤ 32 weeks GA, on CPAP |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ganesh Srinivasan, MD study director
University of Manitoba
Mary S Seshia, MD study director
University of Manitoba
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Distress Syndrome, run by University of Manitoba at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cardiac output (time frame: Day 3 of life till 2 months of age). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2015.