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Diaphragm Electrical Activity of Preterm Infants on nCPAP With Binasal Prongs Versus RAM Cannula

19. september 2018 oppdatert av: Sunnybrook Health Sciences Centre

Effect of Nasal Continuous Positive Airway Pressure (nCPAP) With RAM Cannula Versus Standard Binasal Prongs on Diaphragm Electrical Activity in Very Low Birth Weight (VLBW) Preterm Infants

Preterm babies have immature lungs and frequent pauses in their breathing which often necessitates breathing support. Nasal Continuous Positive Airway Pressure (nCPAP) is one of the most commonly used tools, but the standard interfaces (prongs or mask) may cause nasal-septal injury and discomfort.

The RAM cannula is another interface that consists in soft and curved prongs to avoid this nasal injury, but as the seal is not 100%, suboptimal delivery of airway distending pressure could result if they are used to deliver CPAP, as compared to standard interfaces.

The investigators plan to study very low birth weight preterm babies who are generally well but require some support with their breathing. By inserting a special feeding tube with sensors into the stomach, the investigators can measure the electrical activity of the diaphragm (EAdi), which is an important muscle for breathing. By analyzing EAdi in babies receiving nCPAP either with prongs or ram cannula, the investigators will be able to measure and compare how each method of support affects a baby's breathing. This important study will help us determine the most appropriate breathing support for preterm babies.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Continuous Positive Airway Pressure is one of the most researched and accepted methods of delivering NIV to term and preterm infants. Different interfaces have been used, most frequently binasal prongs or mask. The RAM cannula is a relatively new interface for delivering CPAP in preterm infants, specially to avoid nasal injury and discomfort. However, there are few studies in artificial models with different results in term of the percentage of pressure that is really delivered when we use the RAM cannula. The objective of this study is to to investigate in VLBW preterm infants who require respiratory support by nasal CPAP, whether or not using the RAM cannula as the interface will allow to provide the level of respiratory support equivalent to that with the traditional binasal prongs, measured by diaphragm electrical activity (Edi). The investigators hypothesize that in VLBW preterm infants with respiratory distress syndrome (RDS), the use of CPAP with RAM cannula as the interface may provide lower PEEP (positive end expiratory pressure) than set and increased resistance to gas flow, leading to increased respiratory effort for the patient as reflected by an increase in Edi.

This study will help Neonatologist determine if the amount of support provided with the RAM cannula as interface is equivalent to the support we achieve with the standard interfaces, to select the patients that could benefit from using this interface. The investigators will be able to utilize this information to decide on the most appropriate respiratory support modality for preterm patients.

Studietype

Intervensjonell

Registrering (Forventet)

20

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N3M5
        • Rekruttering
        • Sunnybrook Health Science Centre
        • Ta kontakt med:

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

5 måneder til 7 måneder (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Clinically stable preterm infants (defined as: cardiovascular stability with normal blood pressure and heart rate for GA and no recent increase in apneic episodes or spells and confirmed by the attending neonatologist) with birth weights less than 1500 gr and/or gestational age bellow 32 weeks, admitted to the NICU at Sunnybrook Health Sciences Centre on nasal continuous positive airway pressure of 5 to 8 cmH20 support, for at least 48 h and requiring less than 35% of oxygen.

Exclusion Criteria:

  • Infants with congenital anomalies of the gastrointestinal tract, phrenic nerve damage, diaphragmatic paralysis, esophageal perforation; infants with congenital or acquired neurological deficit (including significant intraventricular hemorrhage greater than Grade II), neonatal seizure; infants with significant congenital heart disease (including symptomatic PDA); infant with congenital anomalies of the diaphragm; infant with congenital anomalies of the respiratory tracts (e.g. Congenital Cystic Adenomatoid Malformation (CCAM)) infants requiring ongoing treatment for sepsis, necrotizing enterocolitis (NEC), antibiotics for lung infections, narcotic analgesics, or gastric motility agents will be excluded. Infants on nasal CPAP and requiring more than 35% oxygen will be excluded from the study. Infants with significant gastric residuals and vomiting, infants with facial anomalies, infants with pneumothorax or pneumomediastinum, and infants in the immediate postoperative period will be excluded. Infants with nasal excoriations will be excluded from the study as they may be electively placed on the RAM cannula to prevent further nasal trauma.

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: CPAP with binasal prongs
Edi will be recorded while the infant is on nasal CPAP with the binasal prongs, with a PEEP of 5-8 cm H2O, for 2 hours. Then, the infant will be switched the interface to the RAM cannula, with a PEEP 2 cmH2O higher, during 2 hours.
Annen: respiratory support- interface
change interface to RAM cannula
Annen: respiratory support- interface
change interface to binasal prongs
Aktiv komparator: CPAP with RAM cannula
Edi will be recorded while the infant is on nasal CPAP with the RAM cannula with a PEEP 2 cmH20 higher than the levels the infant was receiving before starting the study protocol, for 2 hours. Then, the infant will be switched the interface to the binasal prongs with a PEEP between 5-8 cmH2O, during 2 hours.
Annen: respiratory support- interface
change interface to RAM cannula
Annen: respiratory support- interface
change interface to binasal prongs

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Differences in Edi min between CPAP with binasal prongs versus with the RAM cannula
Tidsramme: 4 hours
Measured by the electrical activity of the diaphragm between respiratory support modes (nCPAP with binasal prongs and RAM cannula)
4 hours

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Difference in neural respiratory rate
Tidsramme: 4 hours
Measured by the electrical activity of the diaphragm between respiratory support modes (nCPAP with binasal prongs and RAM cannula).
4 hours
Difference in neural inspiratory time
Tidsramme: 4 hours
Measured by the electrical activity of the diaphragm between respiratory support modes (nCPAP with binasal prongs and RAM cannula).
4 hours
Difference in Edi peak
Tidsramme: 4 hours
Measured by the electrical activity of the diaphragm between respiratory support modes (nCPAP with binasal prongs and RAM cannula).
4 hours
Difference in transcutaneous pCO2
Tidsramme: 4 hours
Measured difference in transcutaneous pCO2 between the 2 different respiratory support modes(nCPAP with binasal prongs and RAM cannula).
4 hours
Difference in number of apnea episodes
Tidsramme: 4 hours
Difference in number of apnea episodes between the 2 different respiratory support modes (nCPAP with binasal prongs and RAM cannula).
4 hours
Needs of oxygen
Tidsramme: 4 hours
Needs of O2 measured by FiO2 on the 2 different respiratory support modes (nCPAP with binasal prongs and RAM cannula).
4 hours

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Sunnybrook Health Sciences Centre

Etterforskere

  • Hovedetterforsker: Michael Dunn, MD, Staff Neonatologist - NICU

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 (Faktiske)

1. november 2016

Primær fullføring (Forventet)

31. desember 2019

Studiet fullført (Forventet)

31. desember 2019

Datoer for studieregistrering

Først innsendt

17. april 2017

Først innsendt som oppfylte QC-kriteriene

19. april 2017

Først lagt ut (Faktiske)

20. april 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

20. september 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. september 2018

Sist bekreftet

1. april 2017

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • RAM cannula study

Plan for individuelle deltakerdata (IPD)

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NEI

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