RecruitingNCT04777760

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


Sponsor

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

Enrollment

400 participants

Start Date

Jan 1, 2021

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 1 MinuteMax Age: 24 Hours

Inclusion Criteria4

  • 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 Criteria4

  • one of the following criteria will be needed
  • major congenital anomalies
  • chromosomal abnormalities
  • upper respiratory tract abnormalities

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Interventions

DRUGone dose of surfactant replacement

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

DRUGtwo 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


Locations(1)

Chen

Chongqing, Chongqing Municipality, China

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NCT04777760


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