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

Recruiting

• Conditions: Acute Respiratory Distress Syndrome; Surfactant Dysfunction; Respiratory Distress Syndrome; Preterm Birth
• Interventions: Drug: one dose of surfactant replacement; Drug: two and more doses of surfactant replacement

• Registration Number: NCT04777760
• Lead Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

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.

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2021-02-26
• Study First Submitted QC: 2021-03-01
• Study First Posted: 2021-03-02
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-13
• Last Update Posted: 2022-10-14
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
one dose of surfactant	one dose of surfactant replacement	the preterm infants diagnosed with NRDS and/or NARDS will be administrated with only one dose of surfactant
two and more doses of surfactant	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

Primary Outcome Measures

Name	Time	Method
bronchopulmonary dysplasia(BPD)	at 36 weeks' gestational age or before discharge from hospital	the preterm infants will be diagnosed with BPD
death	at 36 weeks' gestational age or before discharge from hospital	the preterm infants die
BPD and/or death	at 36 weeks' gestational age or before discharge from hospital	the preterm infants will be diagnosed with BPD and/or death
the predictive powers of one dose of surfactant to diagnose NRDS	seven days after birth	the sensitivity and accuracy of one dose of surfactant to diagnose NRDS
the predictive powers of two and more doses of surfactant to diagnose NARDS	seven days after birth	the sensitivity and accuracy of two and more doses of surfactant to diagnose NARDS

Secondary Outcome Measures

Name	Time	Method
late-onset sepsis(LOS)	at 36 weeks' gestational age or before discharge from hospital	the preterm infants will be diagnosed with LOS
periventricular leukomalacia(PVL)	at 36 weeks' gestational age or before discharge from hospital	the preterm infants will be diagnosed with PVL
patent ductus arteriosis(PDA)	at 36 weeks' gestational age or before discharge from hospital	the preterm infants will be diagnosed with PDA
air leak	at 36 weeks' gestational age or before discharge from hospital	the preterm infants will be diagnosed with air leak
intraventricular hemorrhage(IVH)	before discharge or 36 weeks' gestational age	the preterm infants will be diagnosed with IVH
necrotizing enterocolitis(NEC)	at 36 weeks' gestational age or before discharge from hospital	the preterm infants will be diagnosed with NEC

Trial Locations

Locations (1)

Chen; 🇨🇳 Chongqing, Chongqing, China