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

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04777760
• Other study ID #: surfactant for NRDS and ARDS
• Status: Recruiting
• Start date: January 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2022
• Source: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Contact: Chen Long, MD, PhD
• Phone: +8613883559467
• Email: neuroclong[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Gender: All
• Age group: 1 Minute to 24 Hours

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Hyaline Membrane Disease
• Premature Birth
• Preterm Birth
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Surfactant Dysfunction
• Syndrome

Intervention

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

Locations

Country	Name	City	State
China	Chen	Chongqing	Chongqing

Sponsors (2)

Lead Sponsor	Collaborator
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University	Children's Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bronchopulmonary dysplasia(BPD)	the preterm infants will be diagnosed with BPD	at 36 weeks' gestational age or before discharge from hospital
Primary	death	the preterm infants die	at 36 weeks' gestational age or before discharge from hospital
Primary	BPD and/or death	the preterm infants will be diagnosed with BPD and/or death	at 36 weeks' gestational age or before discharge from hospital
Primary	the predictive powers of one dose of surfactant to diagnose NRDS	the sensitivity and accuracy of one dose of surfactant to diagnose NRDS	seven days after birth
Primary	the predictive powers of two and more doses of surfactant to diagnose NARDS	the sensitivity and accuracy of two and more doses of surfactant to diagnose NARDS	seven days after birth
Secondary	intraventricular hemorrhage(IVH)	the preterm infants will be diagnosed with IVH	before discharge or 36 weeks' gestational age
Secondary	air leak	the preterm infants will be diagnosed with air leak	at 36 weeks' gestational age or before discharge from hospital
Secondary	periventricular leukomalacia(PVL)	the preterm infants will be diagnosed with PVL	at 36 weeks' gestational age or before discharge from hospital
Secondary	necrotizing enterocolitis(NEC)	the preterm infants will be diagnosed with NEC	at 36 weeks' gestational age or before discharge from hospital
Secondary	patent ductus arteriosis(PDA)	the preterm infants will be diagnosed with PDA	at 36 weeks' gestational age or before discharge from hospital
Secondary	late-onset sepsis(LOS)	the preterm infants will be diagnosed with LOS	at 36 weeks' gestational age or before discharge from hospital