An interventional study of Alternating traditional CPAP, NIPPV, and high CPAP in Preterm Birth, Premature Lungs and Respiratory Distress Syndrome in Premature Infant, sponsored by Sunnybrook Health Sciences Centre. Recruiting at 1 site in Canada. Open to participants aged 1 Day to 8 Months. Per ClinicalTrials.gov, last updated 2024-03-06.
Sponsored by Sunnybrook Health Sciences Centre · Not applicable, Interventional, and Supportive care
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.
Our main goal in this study:
To measure and compare the Edi in preterm babies requiring breathing support with CPAP or NIPPV.
Inclusion Criteria (Potential Candidates):
This study involves stable babies who were born with a birth weight of less than 1500 grams and require CPAP.
The steps of the study:
The baby will be assigned to first go on traditional CPAP, NIPPV, or high CPAP, stay for 2 hours, switch to one of the other methods for 2 hours and then spend 2 hours supported by the remaining method. The investigators will continue to record the Edi signals during the 3 methods.
Study duration will be 6 hours from the time of catheter insertion to fit into feeding and handling plans. Upon completion or termination of the study protocol, the participant's baby will be put back to the originally prescribed breathing support.
Routine monitoring for oxygen saturation, heart rate, and respiratory rate will be continued as per the standard of practice in the NICU.
1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.
This study's planned enrollment of 24 is below the median of 60 across 961 interventional studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →Sunnybrook Health Sciences Centre is the lead sponsor of 566 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
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Exclusion Criteria:
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.
Other: Alternating traditional CPAP, NIPPV, and high CPAP
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.
Other: Alternating traditional CPAP, NIPPV, and high CPAP
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.
Other: Alternating traditional CPAP, NIPPV, and high CPAP
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.
Other: Alternating traditional CPAP, NIPPV, and high CPAP
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.
Other: Alternating traditional CPAP, NIPPV, and high CPAP
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.
Other: Alternating traditional CPAP, NIPPV, and high CPAP
The investigators will continue to record the Edi signals during the 3 methods (traditional CPAP, NIPPV, and high CPAP)
The differences in Electrical Activity of the Diaphragm measured in MicroVoltage (Edi minimum) between: 1. Traditional CPAP versus NIPPV. 2. NIPPV versus CPAP (equivalent pressures in cmH2O).
Time frame: 2 hours per each mode of ventilation, total of 6 hours Edi recording
1. Neural respiratory rate per minute
Time frame: 2 hours per each mode of ventilation, total of 6 hours
2. Edi peak measured in MicroVoltage
Time frame: 2 hours per each mode of ventilation, total of 6 hours
3. The difference in transcutaneous pCO2 in mmHg
Time frame: 2 hours per each mode of ventilation, total of 6 hours
4. The difference in oxygen requirements in percent (i.e, 21%)
Time frame: 2 hours per each mode of ventilation, total of 6 hours
Plan to share: No
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