Optimal Dose of Surfactant for Preterm Infants With Respiratory Distress Syndrome

Bronchopulmonary Dysplasia Clinical Trial

Official title:

Optimal Dose of Surfactant for Preterm Infants With Respiratory Distress Syndrome(RDS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04984057
• Other study ID #: Surfactant dose
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2022
• Source: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Contact: Chen Long, PhD,MD
• Phone: 13883559467
• Email: neuroclong[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Minute to 12 Hours

Eligibility

Inclusion Criteria:

• gestation age less than or equal to 32 weeks

• PS is needed

Exclusion Criteria:

• main congenital abnormalities

• parents' refusal or quit

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Ductus Arteriosus, Patent
• Patent Ductus Arteriosus
• Premature Birth
• Preterm
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Drug:
• 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
• PS is given according to the 2019 European RDS management guideline
PS is given according to the 2019 European RDS management guideline

Locations

Country	Name	City	State
China	Children's Hospital of Chongqing Medical University	Chongqing

Sponsors (2)

Lead Sponsor	Collaborator
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University	Children's Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the size of PDA	the size of PDA is zero	within 7 days after birth
Primary	BPD and/or death	the BPD and/or death is diagnosed when the included infants remain needing oxygen at 36 week's gestational age	at 36 week's gestational age