Prospective, Non-Blinded, Randomized Controlled Trial on Early Administration of Pulmonary Surfactant Guided by Lung Ultrasound Scores in Very Preterm Infants.
NCT Number: NCT06491901
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Early Administration of Pulmonary Surfactant Guided by Lung Ultrasound Scores in Very Preterm Infants
Interventions: OTHER: PS was given according to lung ultrasound score|OTHER: PS was given according to clinical criteria
Sponsor: Peking University Third Hospital
Sex: ALL
Age: CHILD
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2025-05-31

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 1:1 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 = 0.05 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.

Primary Outcome Measures: the duration of mechanical ventilation, The duration of mechanical ventilation (both invasive and non-invasive) during hospitalization in the ultrasound and control groups., At 36 weeks PMA or at discharge, whichever came first
Secondary Outcome Measures: the utilization rate of PS, The utilization rate of PS in both groups, Within the first week of life|the proportion of infants receiving the first dose of PS early, The proportion of infants receiving the first dose of PS early (within 3 h after birth) and the time from birth to the initial PS administration, Within the first week of life|the worst oxygenation index (OI), The worst oxygenation index (OI) at different time points following PS administration, Within the first week of life|Lung Ultrasound Scores (LUS), LUS at various intervals following PS administration (at 3 days, 7 days, 14 days, 28 days, and before discharge/at 36 weeks CA), At 36 weeks PMA or at discharge, whichever came first|Preterm comorbidities, The incidence rates of major complications in preterm infants such as BPD, intraventricular hemorrhage (IVH), retinopathy of prematurity (ROP), and necrotizing enterocolitis (NEC), At 36 weeks PMA or at discharge, whichever came first