Surfactant for Neonatal Respiratory Distress Syndrome(NRDS) and Neonatal Acute Respiratory Distress Syndrome(NARDS)

NCT ID: NCT04777760

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2026-12-31

Brief Summary

In preterm infants with neonatal respiratory distress syndrome (NRDS), exogenous pulmonary surfactant(PS) replacement therapy is one of the most important therapeutic breakthrough to reduce neonatal mortality. Nowadays, PS is commonly used in newborn infants with respiratory distress, but the incidences of bronchopulmonary dysplasia(BPD) and/or death are inconsistent. The result indicates that not all preterm infants with respiratory distress can be beneficial from PS.

In 2017, the international neonatal ARDS (NARDS) collaborative group provides the first consensus definition for NARDS. And whether or not PS being beneficial for preterm infants with NARDS remains unknown.

Detailed Description

To date, PS is not recommended to adult and pediatric ARDS. Meantime, systematic review indicates that PS does not demonstrate statistically significant beneficial effects on reducing the mortality and the rate of BPD in term and late preterm infants with meconium aspiration syndrome(MAS). Therefore, a reasonable speculation is that preterm infants with NARDS do not benefit from one dose of PS. And the speculation can explain why not all preterm infants with respiratory distress can be beneficial from PS. In the era of pre-NARDS, the preterm infants fulfilling the definition of NARDS may have been considered as NRDS in the first three days after birth.

According to the diagnostic criteria of NARDS, a key procedure for diagnosis of NARDS is to exclude the newborn infants with NRDS. But no detailed procedures are available to differentiate NRDS from NARDS.

Conditions

Respiratory Distress Syndrome; Preterm Birth; Acute Respiratory Distress Syndrome; Surfactant Dysfunction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

one dose of surfactant

the preterm infants diagnosed with NRDS and/or NARDS will be administrated with only one dose of surfactant

one dose of surfactant replacement

Intervention Type: DRUG

the preterm infants diagnosed with NRDS and/or NARDS will be administrated with only one dose of surfactant

two and more doses of surfactant

the preterm infants diagnosed with NRDS and/or NARDS will be administrated with two and more doses of surfactant

two and more doses of surfactant replacement

Intervention Type: DRUG

the preterm infants diagnosed with NRDS and/or NARDS will be administrated with two and more doses of surfactant

Interventions

one dose of surfactant replacement

the preterm infants diagnosed with NRDS and/or NARDS will be administrated with only one dose of surfactant

Intervention Type: DRUG

two and more doses of surfactant replacement

the preterm infants diagnosed with NRDS and/or NARDS will be administrated with two and more doses of surfactant

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Eligibility requirements for neonates were as follows:

• The gestational age is less than 37 weeks and admitted to neonatal intensive care unit(NICU) in 24 h after birth
• The neonates will be diagnosed with NRDS or NARDS
• The neonates will be at least administrated one dose of surfactant

Exclusion Criteria

one of the following criteria will be needed

• major congenital anomalies
• chromosomal abnormalities
• upper respiratory tract abnormalities

• Minimum Eligible Age: 1 Minute
• Maximum Eligible Age: 24 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

Chen

Chongqing, Chongqing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Chen Long, MD, PhD

Role: CONTACT

neuroclong@126.com

+8613883559467

Facility Contacts

Chen Long, MD,PhD

Role: primary

neuroclong@126.com

+8613883559467

Other Identifiers

surfactant for NRDS and ARDS

Identifier Type: -

Identifier Source: org_study_id