Ignite Creation Date:
2024-07-17 @ 10:49 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06491901
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-07-01
Brief Title:
Prospective Non-Blinded Randomized Controlled Trial on Early Administration of Pulmonary Surfactant Guided by Lung Ultrasound Scores in Very Preterm Infants
Sponsor:
Peking University Third Hospital
Organization:
Peking University Third Hospital
Study Overview
Official Title:
Prospective Non-Blinded Randomized Controlled Trial on Early Administration of Pulmonary Surfactant Guided by Lung Ultrasound Scores in Very Preterm Infants
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Abstract Background Bedside lung ultrasonography has been widely used in neonatal intensive care units NICUs Lung ultrasound scores LUS may predict the need for pulmonary surfactant PS application PS replacement therapy is the key intervention for managing moderate to severe neonatal respiratory distress syndrome NRDS with early PS administration playing a positive role in improving patient outcomes Lung ultrasonography aids in the prompt diagnosis of NRDS while LUS offers a semi-quantitative assessment of lung health However the specific methodologies for utilizing LUS in clinical practice remain controversial This study hypothesizes that in very preterm infants 32 weeks gestational age GA exhibiting respiratory distress symptoms determining PS application through early postnatal LUS combined with clinical indicators as opposed to relying solely on clinical signs and chest X-rays can lead to more timely PS administration reduce mechanical ventilation duration improve patient outcomes and lower the occurrence of bronchopulmonary dysplasia BPD
Methods and design This is a protocol for a prospective non-blinded randomized controlled trial that will be conducted in the NICU of a hospital in China Eligible participants will include very preterm infants 32 weeks GA exhibiting signs of respiratory distress Infants will be randomly assigned in a 11 ratio to either the ultrasound or control group In the ultrasonography group the decision regarding PS administration will be based on a combination of lung ultrasonography and clinical manifestations whereas in the control group it will be determined solely by clinical signs and chest X-rays The primary outcome measure will be the mechanical ventilation duration Statistical analysis will employ independent sample t-tests with a significance level set at α 005 and a power of 80 The study requires 30 infants per group in total 60 infants
Hypothesis This study aims to demonstrate that determining PS application based on a combination of LUS and clinical indicators is superior to traditional approaches
This approach may enhance the accuracy of NRDS diagnosis and facilitate early prediction of PS requirements thereby reducing the duration of mechanical ventilation The findings of this research may contribute valuable insights into the use of LUS to guide PS administration
Methods and design This is a protocol for a prospective non-blinded randomized controlled trial that will be conducted in the NICU of a hospital in China Eligible participants will include very preterm infants 32 weeks GA exhibiting signs of respiratory distress Infants will be randomly assigned in a 11 ratio to either the ultrasound or control group In the ultrasonography group the decision regarding PS administration will be based on a combination of lung ultrasonography and clinical manifestations whereas in the control group it will be determined solely by clinical signs and chest X-rays The primary outcome measure will be the mechanical ventilation duration Statistical analysis will employ independent sample t-tests with a significance level set at α 005 and a power of 80 The study requires 30 infants per group in total 60 infants
Hypothesis This study aims to demonstrate that determining PS application based on a combination of LUS and clinical indicators is superior to traditional approaches
This approach may enhance the accuracy of NRDS diagnosis and facilitate early prediction of PS requirements thereby reducing the duration of mechanical ventilation The findings of this research may contribute valuable insights into the use of LUS to guide PS administration
Detailed Description:
Ultrasound group Lung ultrasonography will be performed within 1 h of admission followed by lung ultrasound scoring If the lung ultrasound confirms RDS and LUS is more than 8 a full dose of PS will be promptly administered at 200 mgkg Poractant Alfa Curosurf If the lung ultrasound does not indicate RDS or if LUS is 8 or less clinical monitoring will continue Should the clinical criteria for NRDS be met a full dose of PS will be administered at 200 mgkg Poractant Alfa Curosurf Lung ultrasound and scoring will be repeated 4 to 10 h post the first PS dose administration Repeated PS administration will occur if the criteria are met with lung ultrasound scoring conducted prior to each administration
Control group In cases where clinical diagnosis confirms NRDS PS will be administered at a dosage of 200 mgkg Poractant Alfa Curosurf If clinical manifestations do not meet the diagnosis of NRDS PS will not be administered
All enrolled infants will undergo lung ultrasound scoring at 24 h 3 days 7 days 14 days 28 days and 36 weeks CA prior to discharge
Control group In cases where clinical diagnosis confirms NRDS PS will be administered at a dosage of 200 mgkg Poractant Alfa Curosurf If clinical manifestations do not meet the diagnosis of NRDS PS will not be administered
All enrolled infants will undergo lung ultrasound scoring at 24 h 3 days 7 days 14 days 28 days and 36 weeks CA prior to discharge
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| M22018 | OTHER_GRANT | None | None |