CPAP vs NIPPV for Premature Infants
Palo Alto (17 mi)Age: < 18
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: Sunnybrook Health Sciences Centre
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
What safety data exists for CPAP vs NIPPV in premature infants?The studies provide safety data comparing CPAP and NIPPV in premature infants. The research includes evaluations of diaphragm electrical activity (Edi) and outcomes like feed intolerance, necrotizing enterocolitis, hemodynamically significant patent ductus arteriosus, intraventricular hemorrhage, retinopathy of prematurity, bronchopulmonary dysplasia, duration of support, and mortality. These studies suggest that NIPPV may be superior to CPAP in certain aspects, such as maintaining higher mean airway pressure and reducing the need for intubation in respiratory distress syndrome. Additionally, the feasibility and tolerance of neurally adjusted ventilation modes, which adjust pressure support based on Edi, have been assessed, indicating potential benefits in preterm infants.13457
Do I have to stop taking my current medications for the trial?The trial protocol does not specify if you need to stop taking your current medications. However, if you are on narcotic analgesics or gastric motility agents, you may not be eligible to participate.
Is Edi Signal Measurement a promising treatment for premature infants in the CPAP vs NIPPV trial?Edi Signal Measurement, which tracks the electrical activity of the diaphragm, is a promising treatment because it helps understand how well premature infants are breathing. This can lead to better respiratory support decisions, potentially improving outcomes for these infants.12357
What data supports the idea that CPAP vs NIPPV for Premature Infants is an effective treatment?The available research shows that nasal intermittent positive pressure ventilation (NIPPV) is often more effective than continuous positive airway pressure (CPAP) for premature infants. One study found that NIPPV is better at maintaining higher airway pressure, which is important for helping infants breathe more easily. Another study indicated that using NIPPV early on can reduce the need for more invasive procedures like intubation. These findings suggest that NIPPV might be a more effective treatment option compared to CPAP for helping premature infants with breathing difficulties.13567
Eligibility Criteria
This trial is for very low birth weight preterm infants who need breathing support due to immature lungs. It's not suitable for those with certain medical conditions that the study doesn't specify.Treatment Details
The study tests how different non-invasive breathing supports affect diaphragm activity in premature babies. It compares traditional CPAP, NIPPV, and high-pressure CPAP to see which helps their tiny lungs best.
6Treatment groups
Experimental Treatment
Group I: Traditional CPAP, then high CPAP, then NIPPVExperimental Treatment1 Intervention
The participant will stay for 2 hours on Traditional CPAP, then 2 hours on high CPAP, then 2 hours on NIPPV. The investigators will continue to record the Edi signals during the 3 methods.
Group II: Traditional CPAP, then NIPPV, then high CPAP.Experimental Treatment1 Intervention
The participant will stay for 2 hours on Traditional CPAP, then 2 hours on NIPPV, then 2 hours on high CPAP. The investigators will continue to record the Edi signals during the 3 methods.
Group III: NIPPV, then traditional CPAP, then high CPAPExperimental Treatment1 Intervention
The participant will stay for 2 hours on NIPPV, then 2 hours on traditional CPAP, then 2 hours on high CPAP. The investigators will continue to record the Edi signals during the 3 methods.
Group IV: NIPPV, then high CPAP, then traditional CPAP.Experimental Treatment1 Intervention
The participant will stay for 2 hours on NIPPV, then 2 hours on high CPAP, then 2 hours on traditional CPAP. The investigators will continue to record the Edi signals during the 3 methods.
Group V: High CPAP, then traditional CPAP, then NIPPV.Experimental Treatment1 Intervention
The participant will stay for 2 hours on High CPAP, then 2 hours on traditional CPAP, then 2 hours on NIPPV. The investigators will continue to record the Edi signals during the 3 methods.
Group VI: High CPAP, then NIPPV, then traditional CPAP.Experimental Treatment1 Intervention
The participant will stay for 2 hours on High CPAP, then 2 hours on NIPPV, then 2 hours on traditional CPAP. The investigators will continue to record the Edi signals during the 3 methods.
Find a clinic near you
Research locations nearbySelect from list below to view details:
Sunnybrook Health Sciences CenterToronto, Canada
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Who is running the clinical trial?
Sunnybrook Health Sciences CentreLead Sponsor
References
Early nasal intermittent positive pressure ventilation versus continuous positive airway pressure for respiratory distress syndrome. [2022]To determine whether early nasal intermittent positive pressure ventilation (NIPPV), in comparison to early continuous positive airway pressure (CPAP), can reduce the need for intubation and mechanical ventilation in preterm neonates with suspected respiratory distress syndrome (RDS).
A randomised cross-over study showed no difference in diaphragm activity during weaning from respiratory support. [2019]We measured electrical activity of the diaphragm (Edi) to compare the breathing effort in preterm infants during weaning from respiratory support with high-flow nasal cannulae (HFNC) or nasal continuous positive airway pressure (nCPAP).
Electrical Activity of the Diaphragm in a Small Cohort of Preterm Infants on Noninvasive Neurally Adjusted Ventilatory Assist and Continuous Positive Airway Pressure: A Prospective Comparative Pilot Study. [2020]To compare the electrical activity of the diaphragm (Edi) of premature infants placed on continuous positive airway pressure (CPAP) with the Edi of premature infants placed on noninvasive neurally adjusted ventilatory assist (NIV NAVA). The secondary aim was to evaluate the feasibility of the use of NIV NAVA mode in the busy tertiary neonatal unit.
Continuous neurally adjusted ventilation: a feasibility study in preterm infants. [2020]To assess the feasibility and tolerance of NeuroPAP, a new non-invasive ventilation mode which continuously adjusts (during both inspiration and expiration) the pressure support proportionally to the diaphragm electrical activity (Edi), in preterm infants and to evaluate the impact on ventilation pressure and Edi.
Comparison of High CPAP versus NIPPV in Preterm Neonates: A Retrospective Cohort Study. [2023]The aim of this study was to compare outcomes following receipt of high continuous positive airway pressure (CPAP) versus nasal intermittent positive pressure ventilation (NIPPV) in extremely preterm neonates.
Diaphragm electrical activity during weaning of nasal high-flow therapy in preterm infants. [2023]To determine whether electrical activity of the diaphragm (Edi) changes with weaning nasal high-flow (HF) therapy in preterm infants according to a standardised protocol.
Nonsynchronized nasal intermittent positive pressure ventilation versus continuous positive airway pressure as a primary mode of respiratory support in neonates (26-40 weeks) admitted in a tertiary care center: A randomized controlled trial. [2023]Continuous positive airway pressure (CPAP) is a standard respiratory care for neonates for last few decades but it too has a high failure rate. Nasal intermittent positive pressure ventilation (NIPPV) is proven to be superior to CPAP in maintaining higher mean airway pressure in neonates with Respiratory Distress Syndrome. The main objective of this study was to compare failure within 72 h of initiation of primary respiratory support between nonsynchronized NIPPV and CPAP in all causes of respiratory distress in newborn infants. Secondarily feed intolerance, Necrotizing enterocolitis (NEC > stage II), hemodynamically significant patent ductus arteriosus, intraventricular hemorrhage (IVH > gradeIII), retinopathy of prematurity (ROP), bronchopulmonary dysplasia (BPD), duration of support and mortality were also compared.