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

Army Medical University of People's Liberation Army

Status: Enrolling

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

Treatments: Drug: one dose of surfactant replacement; Drug: two and more doses of surfactant replacement

Study type: Observational

Funder types: Other

Identifiers

NCT04777760

surfactant for NRDS and ARDS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 1 minute to 24 hours old

Volunteers: No Healthy Volunteers

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

Trial design

400 participants in 2 patient groups

one dose of surfactant

Description:

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

Treatment:

Drug: one dose of surfactant replacement

two and more doses of surfactant

Description:

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

Treatment:

Drug: two and more doses of surfactant replacement