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

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.

Study Overview

• Status: Recruiting
• Conditions: Preterm Birth; Acute Respiratory Distress Syndrome; Respiratory Distress Syndrome; Surfactant Dysfunction
• Intervention / Treatment: Drug: one dose of surfactant replacement; Drug: two and more doses of surfactant replacement

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 Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400042
      • Recruiting
      • Chen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 minute to 1 day (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Preterm infants diagnosed with NRDS or NARDS were eligible. The diagnosis of NARDS was according to the criteria established by Montreux conference in 2017.The diagnosis of NRDS was according to the criteria established by European Consensus Guideline for the management of NRDS in 2019

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
one dose of surfactant; the preterm infants diagnosed with NRDS and/or NARDS will be administrated with only one dose of surfactant	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; the preterm infants diagnosed with NRDS and/or NARDS will be administrated with two and more doses of surfactant	Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bronchopulmonary dysplasia(BPD)	the preterm infants will be diagnosed with BPD	at 36 weeks' gestational age or before discharge from hospital
death	the preterm infants die	at 36 weeks' gestational age or before discharge from hospital
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
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
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Collaborators: Children's Hospital of Chongqing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: February 26, 2021
• First Submitted That Met QC Criteria: March 1, 2021
• First Posted (Actual): March 2, 2021

Study Record Updates

• Last Update Posted (Actual): October 14, 2022
• Last Update Submitted That Met QC Criteria: October 13, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Lung Injury; Infant, Premature, Diseases; Syndrome; Premature Birth; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Hyaline Membrane Disease; Respiratory System Agents; Pulmonary Surfactants
• Other Study ID Numbers: surfactant for NRDS and ARDS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: the data will be accessed after two years of study accomplishment
• IPD Sharing Time Frame: preliminary estimate in 2025
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No