Optimal Dose of Surfactant for Preterm Infants With Respiratory Distress Syndrome

Not Applicable

Recruiting

• Conditions: Respiratory Distress Syndrome, Newborn; Preterm; Patent Ductus Arteriosus; Bronchopulmonary Dysplasia
• Interventions: Drug: PS is given according to the 2019 European RDS management guideline; Drug: PS is stopped when the pressure is equal between bPDA and aPDA.

• Registration Number: NCT04984057
• Lead Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Brief Summary

In preterm infants with neonatal respiratory distress syndrome (RDS), exogenous pulmonary surfactant(PS) replacement therapy is one of the most important therapeutic breakthrough to reduce neonatal incidences of bronchopulmonary dysplasia(BPD) and/or death. But not all preterm infants with RDS can be beneficial. Otherwise, the international neonatal acute RDS (NARDS) collaborative group provides the first consensus definition for NARDS in 2017. And whether or not PS being beneficial in preterm infants with NARDS remains unknown.

Detailed Description

To date, the optimal dose of PS is inconsistent, although the recommended dose of PS is given in the 2019 update guideline. PS is not recommended to adult and pediatric ARDS. Systematic review indicates that PS does not reduce the incidences of BPD and death in infants with meconium aspiration syndrome(MAS, a subtype of NARDS). A reasonable speculation is that preterm infants with NARDS do not benefit from PS. And the speculation can explain why not all preterm infants with RDS can be beneficial from PS. In the era of pre-NARDS, the preterm infants fulfilling the definition of NARDS may have been considered as RDS in the first three days after birth.

Meantime, the dose of PS given to infants with NARDS remains unknown. the aim of the present study is to assess the optimal dose of PS. the control group: PS is given according to the European RDS management guideline in 2019 edition. The study group: PS is stopped when the pressure is equal between before patent ductus arteriosus(bPDA) and after PDA(aPDA). the primary outcomes are the closure rate of PDA within 7 days, the incidence of BPD and/or death.

Study Timeline

• Study First Submitted: 2021-07-24
• Study First Submitted QC: 2021-07-24
• Study First Posted: 2021-07-30
• Study Start: 2021-08-01
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-13
• Last Update Posted: 2022-10-14
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• gestation age less than or equal to 32 weeks
• PS is needed

Exclusion Criteria

• main congenital abnormalities
• parents' refusal or quit

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PS is given according to the 2019 European RDS management guideline	PS is given according to the 2019 European RDS management guideline	PS is given according to the 2019 European RDS management guideline
PS is stopped when the pressure is equal between bPDA and aPDA	PS is stopped when the pressure is equal between bPDA and aPDA.	PS is given and stopped when the pressure is equal between bPDA and aPDA. the pressure is measured using ultrasound

Primary Outcome Measures

Name	Time	Method
the size of PDA	within 7 days after birth	the size of PDA is zero
BPD and/or death	at 36 week's gestational age	the BPD and/or death is diagnosed when the included infants remain needing oxygen at 36 week's gestational age

Trial Locations

Locations (1)

Children's Hospital of Chongqing Medical University; 🇨🇳 Chongqing, China