Ignite Creation Date:
2024-10-25 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06543589
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-05
Brief Title:
Comparing of High Flow Nasal Cannula Versus Cpap for Initial Respiratory Stabilisation of Very Premature Infants
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomised Trial Comparing of High Flow Nasal Cannula Versus Cpap for Initial Respiratory Stabilisation of Very Premature Infants
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SIMPLSAFE3
Brief Summary:
Non-invasive continuous positive airway pressure CPAP stabilizes premature newborns but its optimal pressure is unknown High-flow nasal cannula HFNC is an alternative that minimizes trigeminal stimulation but lacks precise pressure control Initial studies show HFNCs feasibility and effectiveness This study hypothesizes that HFNC can deliver adequate pressure reduce the need for positive pressure ventilation and support safe stabilization of very premature infants The trial compares the effectiveness and safety of HFNC versus CPAP in the delivery room and during transport to the neonatal intensive care unit in very premature infants The primary objective is to compare HFNC and CPAP in reducing the need for positive pressure ventilation in very premature infants immediately after birth The study includes very premature infants delivered between 280 and 316 weeks gestation in 10 tertiary referral centers nine in the Czech Republic one in Slovakia Approximately 443 patients are required to detect a 15 relative decrease in the need for positive pressure ventilation between trial groups Centers will be randomized to either CPAP or HFNC at each time period with parental consent obtained before birth The primary endpoint is the proportion of neonates requiring positive pressure ventilation within the first 10 minutes post-birth
Detailed Description:
Background and Rationale
Non-invasive CPAP is recommended for stabilizing premature newborns but its optimal pressure is unknown Higher pressures without spontaneous breathing lead to PPV which can damage immature lungs and cause complications Frequent mask adjustments needed for CPAP can stimulate reflexes that exacerbate bradycardia
HFNC offers a less disruptive alternative reducing trigeminal stimulation but lacks precise pressure control Initial studies show HFNCs feasibility and effectiveness in some premature infants This study hypothesizes that HFNC can deliver adequate pressure reduce the need for PPV and support safe and effective stabilization of very premature infants VPIs
Hypothesis HFNC reduces upper airway resistance and provides adequate pressure for lung clearance in very immature spontaneously ventilating neonates Less irritation compared to CPAP may reduce PPV needs promoting smooth lung aeration and cardiopulmonary stabilization in very preterm infants
Trial Aim Compare the effectiveness and safety of HFNC and CPAP in the delivery room and during transport to the NICU in severely premature neonates The primary endpoint is the proportion of neonates requiring PPV within the first 10 minutes post-birth
Objectives The primary objective is to compare the effectiveness of HFNC and CPAP in reducing PPV needs in very premature infants immediately after birth
Study Design A stepped-wedge cluster randomized controlled trial where participating centers are randomized to use both HFNC and CPAP during different periods
Study Population Setting
10 tertiary referral centers for perinatal care 9 in the Czech Republic 1 in Slovakia
Participants
Very premature infants delivered between 280 and 316 weeks gestation
Inclusion Criteria
Gestational age between 280 and 316 weeks Written informed consent from parentslegal guardians Exclusion Criteria
Peripartal hypoxia with pH 71 Significant congenital malformations IUGR with estimated weight below 800g Conditions affecting breathingventilation or oxygenation Decision for palliative neonatal care Sample Size Calculation To detect a 15 relative decrease in PPV administration approximately 443 patients are required The trial will include five clusters each recruiting 15 patients per period over 6-10 periods 90 days each
Recruitment and Consent Centers will be randomized to either CPAP or HFNC at each time period Parental consent will be obtained before birth ensuring parents are adequately informed
Method Primary Endpoint
Proportion of neonates requiring PPV within the first 10 minutes post-birth Secondary Endpoints
Achieving SpO2 80 within 5 minutes without PPV Achieving SpO2 90 with FiO2 040 within 10 minutes without PPV Stabilization on selected ventilatory support with FiO2 035 without PPV at 3 hours of life
Non-invasive CPAP is recommended for stabilizing premature newborns but its optimal pressure is unknown Higher pressures without spontaneous breathing lead to PPV which can damage immature lungs and cause complications Frequent mask adjustments needed for CPAP can stimulate reflexes that exacerbate bradycardia
HFNC offers a less disruptive alternative reducing trigeminal stimulation but lacks precise pressure control Initial studies show HFNCs feasibility and effectiveness in some premature infants This study hypothesizes that HFNC can deliver adequate pressure reduce the need for PPV and support safe and effective stabilization of very premature infants VPIs
Hypothesis HFNC reduces upper airway resistance and provides adequate pressure for lung clearance in very immature spontaneously ventilating neonates Less irritation compared to CPAP may reduce PPV needs promoting smooth lung aeration and cardiopulmonary stabilization in very preterm infants
Trial Aim Compare the effectiveness and safety of HFNC and CPAP in the delivery room and during transport to the NICU in severely premature neonates The primary endpoint is the proportion of neonates requiring PPV within the first 10 minutes post-birth
Objectives The primary objective is to compare the effectiveness of HFNC and CPAP in reducing PPV needs in very premature infants immediately after birth
Study Design A stepped-wedge cluster randomized controlled trial where participating centers are randomized to use both HFNC and CPAP during different periods
Study Population Setting
10 tertiary referral centers for perinatal care 9 in the Czech Republic 1 in Slovakia
Participants
Very premature infants delivered between 280 and 316 weeks gestation
Inclusion Criteria
Gestational age between 280 and 316 weeks Written informed consent from parentslegal guardians Exclusion Criteria
Peripartal hypoxia with pH 71 Significant congenital malformations IUGR with estimated weight below 800g Conditions affecting breathingventilation or oxygenation Decision for palliative neonatal care Sample Size Calculation To detect a 15 relative decrease in PPV administration approximately 443 patients are required The trial will include five clusters each recruiting 15 patients per period over 6-10 periods 90 days each
Recruitment and Consent Centers will be randomized to either CPAP or HFNC at each time period Parental consent will be obtained before birth ensuring parents are adequately informed
Method Primary Endpoint
Proportion of neonates requiring PPV within the first 10 minutes post-birth Secondary Endpoints
Achieving SpO2 80 within 5 minutes without PPV Achieving SpO2 90 with FiO2 040 within 10 minutes without PPV Stabilization on selected ventilatory support with FiO2 035 without PPV at 3 hours of life
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None