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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-24
SponsorDaping Hospital and the Research Institute of Surgery of the Third Military Medical University

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

major congenital anomalies

chromosomal abnormalities

upper respiratory tract abnormalities

Trial design

Treatments tested in this trial

  • one dose of surfactant replacement
  • two and more doses of surfactant replacement

Treatment groups

400 Participants
are divided into 2 treatment groups

Sponsors and collaborators

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

Lead sponsor

Children's Hospital of Chongqing Medical University

Sponsor institution

Children's Hospital of Chongqing Medical University

Collaborator