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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-24
SponsorDaping Hospital and the Research Institute of Surgery of the Third Military Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

major congenital anomalies

chromosomal abnormalities

upper respiratory tract abnormalities

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • one dose of surfactant replacement

    Drug

    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

    Drug

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

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: one dose of surfactant1 intervention
Group B: two and more doses of surfactant1 intervention

Trial outcomes

Primary outcomes

1

bronchopulmonary dysplasia(BPD)

the preterm infants will be diagnosed with BPD

Time frame
at 36 weeks' gestational age or before discharge from hospital
2

death

the preterm infants die

Time frame
at 36 weeks' gestational age or before discharge from hospital
3

BPD and/or death

the preterm infants will be diagnosed with BPD and/or death

Time frame
at 36 weeks' gestational age or before discharge from hospital
4

the predictive powers of one dose of surfactant to diagnose NRDS

the sensitivity and accuracy of one dose of surfactant to diagnose NRDS

Time frame
seven days after birth

Secondary outcomes

1

intraventricular hemorrhage(IVH)

the preterm infants will be diagnosed with IVH

Time frame
before discharge or 36 weeks' gestational age
2

air leak

the preterm infants will be diagnosed with air leak

Time frame
at 36 weeks' gestational age or before discharge from hospital
3

periventricular leukomalacia(PVL)

the preterm infants will be diagnosed with PVL

Time frame
at 36 weeks' gestational age or before discharge from hospital
4

necrotizing enterocolitis(NEC)

the preterm infants will be diagnosed with NEC

Time frame
at 36 weeks' gestational age or before discharge from hospital

Other outcomes

Sponsors and contacts

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

Lead sponsor

Children's Hospital of Chongqing Medical University

Sponsor institution

Children's Hospital of Chongqing Medical University

Collaborator