Status:
NOT_YET_RECRUITING
Prospective, Non-Blinded, Randomized Controlled Trial on Early Administration of Pulmonary Surfactant Guided by Lung Ultrasound Scores in Very Preterm Infants.
Lead Sponsor:
Peking University Third Hospital
Conditions:
Early Administration of Pulmonary Surfactant Guided by Lung Ultrasound Scores in Very Preterm Infants
Eligibility:
All Genders
10-5 years
Phase:
NA
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) applica...
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 wil...
Eligibility Criteria
Inclusion
- Infants who meet all of the following criteria will be included: (1) very preterm infants with a GA of less than 32 weeks; (2) presence of respiratory distress after birth, such as a respiratory rate of more than 60 breaths/min, grunting, nasal flaring, intercostal retractions, and/or cyanosis; (3) born in the authors' hospital.
Exclusion
- Infants who meet any of the following criteria will be excluded: (1) infants who have received PS treatment in the delivery room or external setting after birth; (2) infants with known or confirmed congenital abnormalities, especially cardiopulmonary deformities during diagnosis or treatment; (3) presence of severe complications at birth (severe asphyxia, hemorrhagic shock, pneumonia, pneumothorax, early-onset sepsis, and pleural effusion) or other diseases not caused by PS deficiency; (4) infants who die within 72 h after birth, are transferred to another hospital for surgery, or have incomplete data; and (5) those with families who do not consent to participate in this study.
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06491901
Start Date
August 1 2024
End Date
May 31 2025
Last Update
July 9 2024
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