Effect of Continuous Positive Airway Pressure Delivered by Two Different Modalities on Breathing Pattern in Preterm Infants
Effects of Continuous Positive Airway Pressure (CPAP) Delivered by High Flow Nasal Cannula Versus Nasal Continuous Positive Airway Pressure on the Diaphragm Electrical Activity in Very Low Birth Weight Preterm Infants
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Many preterm very low birth weight infants require continuous positive airway pressure(CPAP) for breathing support because of lung immaturity. CPAP can be delivered by the infant flow(TM) device which is well studied. Prolonged use of nasal prongs CPAP has been shown to cause discomfort and, rarely, nasal injury leading to long term disfigurement. On the other hand, High flow nasal cannula (HFNC) ,which is another modality of delivering CPAP, creates less pressure on the nose and less disfiguring effect but previous research showed that the use of HFNC may be less effective than IF-CPAP in providing breathing support in these infants.
We plan to study 10 stable preterm infants born less than 32 weeks' gestation and 1.5 kilograms at birth after being stable for at least 48hours on IF-CPAP. babies will be randomized to start on IF-CPAP or HFNC for 30 minutes. After 45 minutes of adaptation, baby will be switched to the other modality for another 30 minutes. By inserting a specialized feeding tube with sensors into the stomach, we can measure the electrical activity of the diaphragm (EAdi). By analysing EAdi with each modality of delivering CPAP, we want to directly assess how HFNC affects breathing compared to IF-CPAP.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
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Ontario
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Toronto, Ontario, Canada
- Sunnybrook Health Sciences Centre
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Birth weights ≤ 1500g
- Gestational age less than 32 week
- Stable on nasal continuous positive airway pressure (CPAP) of 5-6cmH20 support for at least 48 hours
- Treated with methylxanthines for apnea of prematurity
- In less than 35% oxygen
Exclusion Criteria:
- Congenital and acquired problem of the gastrointestinal tract
- Phrenic nerve injury and/or diaphragm paralysis
- Esophageal perforation/tracheoesophageal fistula
- Congenital/acquired neurological deficit and/or seizures
- Hemodynamic instability
- Congenital heart disease (including symptomatic patent ductus arteriosus)
- Undergoing treatment for sepsis or pneumonia
- Use of muscle relaxants, narcotic analgesics, or gastric motility agents
- Congenital anomalies of respiratory tract (e.g. CCAM)
- Infants requiring more than 35% oxygen
- Infants with facial anomalies
- Infants with pneumothorax and/or pneumomediatinum
- Infants in the immediate postoperative period
- Infants with significant gastric residues and vomiting
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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EAdi 1
babies in this group will first receive CPAP through IF-CPAP for 30 minutes.
After another 45 minutes, they will be switched to HFNC for 30 minutes.
EAdi will be recorded for the last 15 minutes of each 30 minutes period.
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|
EAdi 2
babies in this group will first receive CPAP through HFNC for 30 minutes.
After another 45 minutes, they will be switched to IF-CPAP for 30 minutes.
EAdi will be recorded for the last 15 minutes of each 30 minutes period.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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The difference in the tonic EAdi between IF-CPAP and HFNC .
Tidsramme: During the 4-hour study period.
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Patients will be randomized in two groups, one group will start on IF-CPAP for 30 minutes.
After another 45 minutes, this group will be switched to HFNC for another 30 minutes.
The other group will start on HFNC and then switched to IF-CPAP.
EAdi will be analyzed in the last 15 minutes of each 30 minutes period.
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During the 4-hour study period.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Difference in the number of apnea episodes (breathing pauses) on EAdi recorded with each modality.
Tidsramme: During the 4-hour study period.
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During the 4-hour study period.
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Difference in episodes of clinically significant apnea with HFNC and IF-CPAP.
Tidsramme: During the 4-hour study period.
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During the 4-hour study period.
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Indices of respiratory muscle effort (inspiratory and expiratory) will be calculated from Edi waveform.
Tidsramme: During the 4-hour study period.
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These indices include the phasic Edi to the peak, mean inspiratory Edi, Edi-time product, post inspiratory activity and all neural timings.
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During the 4-hour study period.
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Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Michael Dunn, MD, Sunnybrook Health Sciences Centre
- Ledende efterforsker: Nehad Nasef, M.B.B.Ch, Sunnybrook Health Sciences Centre
- Ledende efterforsker: Maureen Reilly, RRT, Sunnybrook Health Sciences Centre
- Ledende efterforsker: Patti Schurr, RN(EC), Sunnybrook Health Sciences Centre
- Ledende efterforsker: Jennifer Beck, Ph.D., Unity Health Toronto
- Studieleder: Eugene Ng, MD, Sunnybrook Health Sciences Centre
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 254-2010
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