Actively Recruiting

Phase Not Applicable
Age: 1Day - 8Months
All Genders
NCT06295484

Effect of Nasal CPAP Versus NIPPV On Diaphragm Electrical Activity (Edi) In VLBW Preterm Infants

Led by Sunnybrook Health Sciences Centre · Updated on 2024-03-06

24

Participants Needed

1

Research Sites

279 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Background: In premature babies, many organ systems are not fully grown and developed, including the lungs and respiratory muscles, so they will need breathing support to help them to breathe by preventing their tiny air sacs to collapse. This support commonly done by CPAP and Non-Invasive Positive Pressure Ventilation (NIPPV) therapy by giving some pressure and oxygen to their lungs through an interface placed on their noses. Both (CPAP and NIPPV) can be used as a support modality for respiratory distress syndrome, apnea of prematurity, and providing breathing support after extubation from the full mechanical breathing support. The CPAP supports the baby's immature lungs by delivering constant pressure to keep their lungs and breathing well supported. Whereas the NIPPV will use constant pressure in the background (similar to CPAP), and on top, it will give extra intermittent puffs at regular intervals to support the baby's breathing. The NIPPV is the most common choice by the clinicians when the traditional CPAP is no longer effective, to avoid the full mechanical breathing support and to protect the developing lungs. Studies suggested that NIPPV is better than the traditional CPAP in reducing the need of the baby to need full mechanical breathing support. This might be because the investigators tend to use lower pressures with CPAP (5-8 cmH2O) compared to relatively higher pressures with NIPPV. More recently, clinicians showed the safety of using equivalent higher CPAP pressures (\>9 cmH2O) to what the investigators use in the NIPPV in preterm babies. One way to measure the support that the investigators are giving to the patient with the different devices is to measure the diaphragm activity, which the investigators call the Edi signal, using a special feeding catheter and a specific machine to measure it. The catheter is placed and used as a routine feeding tube but has sensors at the end to measure this Edi signal. One opening of the tube will be connected to a computer to record the Edi signals. The other opening of the tube will be used for feeding.

CONDITIONS

Official Title

Effect of Nasal CPAP Versus NIPPV On Diaphragm Electrical Activity (Edi) In VLBW Preterm Infants

Who Can Participate

Age: 1Day - 8Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinically stable preterm infants with normal blood pressure and heart rate for gestational age and no recent increase in apneic episodes
  • Birth weight less than 1500 grams
  • Admitted to NICU on nasal CPAP pressure of 5 to 8 cmH2O for at least 48 hours
  • Requiring less than 35% oxygen support
Not Eligible

You will not qualify if you...

  • Congenital anomalies of the gastrointestinal tract
  • Phrenic nerve damage
  • Diaphragmatic paralysis
  • Esophageal perforation
  • Congenital or acquired neurological deficits including significant intraventricular hemorrhage greater than Grade II or neonatal seizures
  • Significant congenital heart disease including symptomatic PDA
  • Congenital anomalies of the diaphragm or respiratory tracts such as CCAM
  • Ongoing treatment for sepsis
  • Ongoing treatment for necrotizing enterocolitis (NEC)
  • Ongoing treatment for lung infections
  • Use of narcotic analgesics or gastric motility agents
  • Infants on nasal CPAP requiring more than 35% oxygen
  • Significant gastric residuals and vomiting
  • Facial anomalies
  • Pneumothorax or pneumomediastinum
  • Immediate postoperative period

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Sunnybrook Health Sciences Center

Toronto, Ontario, Canada, M4N 3M5

Actively Recruiting

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Research Team

M

Maher Shahroor, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

6

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Effect of Nasal CPAP Versus NIPPV On Diaphragm Electrical Activity (Edi) In VLBW Preterm Infants | DecenTrialz