protocolSection identificationModule nctId: NCT06295484, orgStudyIdInfo id: 5136, briefTitle: Effect of Nasal CPAP Versus NIPPV On Diaphragm Electrical Activity (Edi) In VLBW Preterm Infants, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-08-21, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Sunnybrook Health Sciences Centre, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Preterm Birth, conditions: Premature Lungs, conditions: Respiratory Distress Syndrome in Premature Infant, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: 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. We 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, your 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., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Alternating traditional CPAP, NIPPV, and high CPAP, outcomesModule primaryOutcomes measure: 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)., secondaryOutcomes measure: 1. Neural respiratory rate per minute, secondaryOutcomes measure: 2. Edi peak measured in MicroVoltage, secondaryOutcomes measure: 3. The difference in transcutaneous pCO2 in mmHg, secondaryOutcomes measure: 4. The difference in oxygen requirements in percent (i.e, 21%), eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 8 Months, stdAges: CHILD, contactsLocationsModule locations facility: Sunnybrook Health Sciences Center, status: RECRUITING, city: Toronto, state: Ontario, zip: M4N 3M5, country: Canada, contacts name: Maher Shahroor, MD, role: CONTACT, phone: (416) 480-6100, phoneExt: 687939, email: maher.shahroor@sunnybrook.ca, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False