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

• ClinicalTrials.gov Identifier: NCT04777760
• Recruitment Status: Recruiting
• First Posted: March 2, 2021
• Last Update Posted: October 14, 2022
• Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Collaborator: Children's Hospital of Chongqing Medical University
• Information provided by (Responsible Party): Chen Long,MD, Children's Hospital of Chongqing Medical University

Study Description

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.

Condition or disease	Intervention/treatment
Respiratory Distress Syndrome; Preterm Birth; Acute Respiratory Distress Syndrome; Surfactant Dysfunction	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 Design

• Study Type: Observational
• Estimated Enrollment: 400 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Surfactant for Neonatal Respiratory Distress Syndrome(NRDS) and Neonatal Acute Respiratory Distress Syndrome(NARDS)
• Actual Study Start Date: January 1, 2021
• Estimated Primary Completion Date: December 31, 2024
• Estimated Study Completion Date: December 31, 2024

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. bronchopulmonary dysplasia(BPD) [ Time Frame: at 36 weeks' gestational age or before discharge from hospital ]
   the preterm infants will be diagnosed with BPD
2. death [ Time Frame: at 36 weeks' gestational age or before discharge from hospital ]
   the preterm infants die
3. BPD and/or death [ Time Frame: at 36 weeks' gestational age or before discharge from hospital ]
   the preterm infants will be diagnosed with BPD and/or death
4. the predictive powers of one dose of surfactant to diagnose NRDS [ Time Frame: seven days after birth ]
   the sensitivity and accuracy of one dose of surfactant to diagnose NRDS
5. the predictive powers of two and more doses of surfactant to diagnose NARDS [ Time Frame: seven days after birth ]
   the sensitivity and accuracy of two and more doses of surfactant to diagnose NARDS

Secondary Outcome Measures :

1. intraventricular hemorrhage(IVH) [ Time Frame: before discharge or 36 weeks' gestational age ]
   the preterm infants will be diagnosed with IVH
2. air leak [ Time Frame: at 36 weeks' gestational age or before discharge from hospital ]
   the preterm infants will be diagnosed with air leak
3. periventricular leukomalacia(PVL) [ Time Frame: at 36 weeks' gestational age or before discharge from hospital ]
   the preterm infants will be diagnosed with PVL
4. necrotizing enterocolitis(NEC) [ Time Frame: at 36 weeks' gestational age or before discharge from hospital ]
   the preterm infants will be diagnosed with NEC
5. patent ductus arteriosis(PDA) [ Time Frame: at 36 weeks' gestational age or before discharge from hospital ]
   the preterm infants will be diagnosed with PDA
6. late-onset sepsis(LOS) [ Time Frame: at 36 weeks' gestational age or before discharge from hospital ]
   the preterm infants will be diagnosed with LOS

Eligibility Criteria

• Ages Eligible for Study: 1 Minute to 24 Hours (Child)
• Sexes 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

Criteria

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

Contacts and Locations

Contacts

Contact: Chen Long, MD, PhD; +8613883559467; neuroclong@126.com

Locations

China, Chongqing

Chen; Recruiting

Chongqing, Chongqing, China, 400042

Contact: Chen Long, MD,PhD +8613883559467 neuroclong@126.com

Sponsors and Collaborators

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

Children's Hospital of Chongqing Medical University

More Information

• Responsible Party: Chen Long,MD, director, Children's Hospital of Chongqing Medical University
• ClinicalTrials.gov Identifier: NCT04777760
• Other Study ID Numbers: surfactant for NRDS and ARDS
• First Posted: March 2, 2021
• Last Update Posted: October 14, 2022
• Last Verified: October 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: the data will be accessed after two years of study accomplishment
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)
• Time Frame: preliminary estimate in 2025

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Hyaline Membrane Disease; Premature Birth; Syndrome; Disease; Pathologic Processes; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Lung Injury; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Pulmonary Surfactants; Respiratory System Agents