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Effect of Continuous Positive Airway Pressure Delivered by Two Different Modalities on Breathing Pattern in Preterm Infants

16. juni 2015 oppdatert av: Sunnybrook Health Sciences Centre

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

In this study, the investigators want to observe how continuous positive airway pressure delivered by two different modalities affects breathing pattern in small preterm infants. Using a specialized feeding tube in the stomach, the investigators can measure and compare how the diaphragm (a large breathing muscle) might be affected by those two modalities.

Studieoversikt

Status

Fullført

Detaljert 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.

Studietype

Observasjonsmessig

Registrering (Forventet)

10

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Ontario
      • Toronto, Ontario, Canada
        • Sunnybrook Health Sciences Centre

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

2 dager til 1 år (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

clinically stable preterm infants with birth weight less than 1.5 kilograms and gestational age less than 32 weeks admitted to the neonatal intensive care unit at Sunnybrook Health Sciences centre on nasal continuos positive airway pressure(CPAP) of 5-6 cmH2O support for at least 48 hours, treated with Methylxanthines for apnea of prematurity and in less than 35% oxygen.

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
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.
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
The difference in the tonic EAdi between IF-CPAP and HFNC .
Tidsramme: During the 4-hour study period.
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.
During the 4-hour study period.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Difference in the number of apnea episodes (breathing pauses) on EAdi recorded with each modality.
Tidsramme: During the 4-hour study period.
During the 4-hour study period.
Difference in episodes of clinically significant apnea with HFNC and IF-CPAP.
Tidsramme: During the 4-hour study period.
During the 4-hour study period.
Indices of respiratory muscle effort (inspiratory and expiratory) will be calculated from Edi waveform.
Tidsramme: During the 4-hour study period.
These indices include the phasic Edi to the peak, mean inspiratory Edi, Edi-time product, post inspiratory activity and all neural timings.
During the 4-hour study period.

Samarbeidspartnere og etterforskere

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Etterforskere

  • Hovedetterforsker: Michael Dunn, MD, Sunnybrook Health Sciences Centre
  • Hovedetterforsker: Nehad Nasef, M.B.B.Ch, Sunnybrook Health Sciences Centre
  • Hovedetterforsker: Maureen Reilly, RRT, Sunnybrook Health Sciences Centre
  • Hovedetterforsker: Patti Schurr, RN(EC), Sunnybrook Health Sciences Centre
  • Hovedetterforsker: Jennifer Beck, Ph.D., Unity Health Toronto
  • Studieleder: Eugene Ng, MD, Sunnybrook Health Sciences Centre

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mai 2011

Primær fullføring (Faktiske)

1. november 2012

Studiet fullført (Faktiske)

1. desember 2012

Datoer for studieregistrering

Først innsendt

23. mars 2011

Først innsendt som oppfylte QC-kriteriene

30. mars 2011

Først lagt ut (Anslag)

31. mars 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

18. juni 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. juni 2015

Sist bekreftet

1. juni 2015

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 254-2010

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