UnknownNot Applicable

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

Canada20 participantsStarted 2016-11-01

Plain-language summary

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.

Who can participate

Age range

23 Weeks – 32 Weeks

Sex

ALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 posto…

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What they're measuring

Differences in Edi min between CPAP with binasal prongs versus with the RAM cannula

Timeframe: 4 hours

Trial details

NCT IDNCT03121781

SponsorSunnybrook Health Sciences Centre

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12-31

Contact for this trial

Michael Dunn, MD

(416) 480-6100 michael.dunn@sunnybrook.ca

View on ClinicalTrials.gov More Preterm Infants trials