NCT06295484

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

Recruiting now NA Last updated 6 March 2024

What this trial tests

NA trial testing Alternating traditional CPAP, NIPPV, and high CPAP in Preterm Birth in 24 participants. Currently enrolling.

Timeline

21 August 2021

Primary endpoint
31 December 2025

31 December 2026

Quick facts

Lead sponsor	Sunnybrook Health Sciences Centre
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	supportive care
Enrollment	24
Start date	21 August 2021
Primary completion	31 December 2025
Estimated completion	31 December 2026
Sites	1 location across Canada

Drugs / interventions tested

• Alternating traditional CPAP, NIPPV, and high CPAP

Conditions studied

• Preterm Birth — all drugs for Preterm Birth →
• Premature Lungs — all drugs for Premature Lungs →
• Respiratory Distress Syndrome in Premature Infant — all drugs for Respiratory Distress Syndrome in Premature Infant →

Sponsor

Sunnybrook Health Sciences Centre — full company profile →

Who can join

Adults 1 Day to 8 Months, any sex, with Preterm Birth or Premature Lungs. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.