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

3 augusti 2015 uppdaterad av: Dr. Yaser Ali, University of Manitoba

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

10

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Kanada
    • Manitoba
      • Winnipeg, Manitoba, Kanada, R2H 2A6
        • St. Boniface General Hospital
      • Winnipeg, Manitoba, Kanada, R3A 1S1
        • Health Sciences Center

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

2 dagar till 2 månader (Barn)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Sannolikhetsprov

Studera befolkning

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

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
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.
Övrig: Echocardiography

Measurement of:

  • Left ventricular output (LVO).
  • Right ventricular output (RVO).
  • Assessment of the Mesenteric Artery Flow.
Övrig: 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.
Andra namn:
  • NIRS

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in cardiac output
Tidsram: 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).
Day 3 of life till 2 months of age
Changes in Superior Mesenteric Artery and Middle Cerebral Artery Doppler flow.
Tidsram: Day 3 of life till 2 months of age
Day 3 of life till 2 months of age
Cerebral and mesenteric regional tissue oxygenation
Tidsram: 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.
Day 3 of life till 2 months of age

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Manitoba

Utredare

  • Studierektor: Ganesh Srinivasan, MD, University of Manitoba
  • Studierektor: Mary S Seshia, MD, University of Manitoba

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 augusti 2013

Primärt slutförande (Faktisk)

1 augusti 2014

Avslutad studie (Faktisk)

1 augusti 2014

Studieregistreringsdatum

Först inskickad

19 juli 2013

Först inskickad som uppfyllde QC-kriterierna

10 september 2013

Första postat (Uppskatta)

16 september 2013

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

4 augusti 2015

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

3 augusti 2015

Senast verifierad

1 augusti 2015

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • B2013: 055

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