Using surfactant in preterm newborns with NRDS or NARDS

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

This research will try to see if giving one dose versus two or more doses of surfactant helps preterm infants with NRDS or NARDS.

Quick facts

• Study type: Observational
• Enrollment: 400 (estimated)
• Ages: 1 Minute to 24 Hours
• Sex: All
• Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University (Academic / other)
• Locations: 1 site (Chongqing, Chongqing Municipality)
• Trial ID: NCT04777760 on ClinicalTrials.gov

What this trial studies

This is an observational study of preterm infants (<37 weeks) admitted to a NICU within 24 hours who are diagnosed with neonatal respiratory distress syndrome (NRDS) or neonatal ARDS (NARDS) and receive at least one dose of pulmonary surfactant. Participants will be grouped by whether they received a single dose or multiple doses of surfactant and their clinical outcomes (including bronchopulmonary dysplasia and death) will be recorded. Infants with major congenital anomalies, chromosomal abnormalities, or upper airway abnormalities are excluded. The study is conducted at participating hospitals in Chongqing, China and analyzes real-world surfactant use rather than assigning treatments.

Who should consider this trial

Good fit: Preterm infants under 37 weeks gestation admitted to the participating NICU within 24 hours of birth who are diagnosed with NRDS or NARDS and receive at least one dose of surfactant, without major congenital or chromosomal anomalies or upper airway defects, are eligible.

Not a fit: Term infants, those with major congenital or chromosomal abnormalities or upper airway defects, and infants not treated in the participating NICU are unlikely to benefit from enrollment.

Why it matters

Potential benefit: If successful, the study could clarify which preterm infants benefit from additional doses of surfactant and help guide treatment decisions to reduce lung injury or death.

How similar studies have performed: Surfactant replacement is well established for classic NRDS but prior reviews show inconsistent effects on bronchopulmonary dysplasia or death in some neonatal groups and surfactant has not shown clear benefit in adult/pediatric ARDS, so results are mixed rather than uniformly successful.

Eligibility 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

Where this trial is running

Chongqing, Chongqing Municipality

• Chen — Chongqing, Chongqing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Chen Long, MD, PhD

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