Prospective, Non-Blinded, Randomized Controlled Trial on Early Administration of Pulmonary Surfactant Guided by Lung Ultrasound Scores in Very Preterm Infants.

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.

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

If the lung ultrasound confirms RDS and LUS is more than 8, a full dose of PS will be promptly administered at 200 mg/kg (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 mg/kg (Poractant Alfa, Curosurf®). In terms of the administration method, less-invasive surfactant administration (LISA) will be employed for infants in a non-invasive ventilation state, while those in an invasive ventilation state will receive PS via endotracheal tube.

OTHER

PS was given according to clinical criteria

In cases where clinical diagnosis confirms NRDS, PS will be administered at a dosage of 200 mg/kg (Poractant Alfa, Curosurf®). LISA will be employed for infants in a non-invasive ventilation state, while those in an invasive ventilation state will receive PS via endotracheal tube. If clinical manifestations do not meet the diagnosis of NRDS, PS will not be administered.

Sponsors & Collaborators

• Peking University Third Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

10 Minutes

Max Age

5 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-08-01

Primary Completion

2025-05-31

Completion

2025-05-31