Optimal Dose of Surfactant for Preterm Infants With Respiratory Distress Syndrome

NCT ID: NCT04984057

Last Updated: 2022-10-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2024-12-31

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.

Conditions

Respiratory Distress Syndrome, Newborn; Patent Ductus Arteriosus; Bronchopulmonary Dysplasia; Preterm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

PS is stopped when the pressure is equal between bPDA and aPDA.

Intervention Type: DRUG

PS is given and stopped when the pressure is equal between bPDA and aPDA. the pressure is measured using ultrasound

PS is given according to the 2019 European RDS management guideline

PS is given according to the 2019 European RDS management guideline

Group Type: ACTIVE_COMPARATOR

PS is given according to the 2019 European RDS management guideline

Intervention Type: DRUG

PS is given according to the 2019 European RDS management guideline

Interventions

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

Intervention Type: DRUG

PS is given according to the 2019 European RDS management guideline

PS is given according to the 2019 European RDS management guideline

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• main congenital abnormalities
• parents' refusal or quit

• Minimum Eligible Age: 1 Minute
• Maximum Eligible Age: 12 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital of Chongqing Medical University

OTHER

Sponsor Role: collaborator

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

OTHER

Sponsor Role: lead

Responsible Party

Chen Long,MD

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Children's Hospital of Chongqing Medical University

Chongqing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Chen Long, PhD,MD

Role: CONTACT

neuroclong@126.com

13883559467 ext. 86

Facility Contacts

Chen Long, PhD,MD

Role: primary

neuroclong@126.com

13883559467 ext. 86

Other Identifiers

Surfactant dose

Identifier Type: -

Identifier Source: org_study_id