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Completed

NCT Number: NCT01942967

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

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.

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Key information

Age range

48 hour–2 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Health Sciences Center, Winnipeg, Manitoba, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

echocardiography

Other

Measurement of:

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

Near Infrared Spectroscopy Monitoring

Other

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

Other names: NIRS

Primary outcomes

  1. 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:

    • Subcostal.
    • Apical.
    • Long and short axis parasternal.
    • Suprasternal

    Measurements:

    • Left ventricular output (LVO).
    • Right ventricular output (RVO).
  2. Changes in Superior Mesenteric Artery and Middle Cerebral Artery Doppler flow.

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

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 16, 2013
Registry last updated
Aug 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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