Surfactant for Neonatal Respiratory Distress Syndrome(NRDS) and Neonatal Acute Respiratory Distress Syndrome(NARDS)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: one dose of surfactant replacement, two and more doses of surfactant replacement.
- Who it may be relevant to
- Registry conditions: Respiratory Distress Syndrome, Preterm Birth, Acute Respiratory Distress Syndrome, Surfactant Dysfunction. Basic parameters: 1 Minute — 24 Hours · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
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.
Interventions
- Drug one dose of surfactant replacement
the preterm infants diagnosed with NRDS and/or NARDS will be administrated with only one dose 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
Primary outcome measures
- bronchopulmonary dysplasia(BPD) [Time frame: at 36 weeks' gestational age or before discharge from hospital]
- death [Time frame: at 36 weeks' gestational age or before discharge from hospital]
- BPD and/or death [Time frame: at 36 weeks' gestational age or before discharge from hospital]
- the predictive powers of one dose of surfactant to diagnose NRDS [Time frame: seven days after birth]
- the predictive powers of two and more doses of surfactant to diagnose NARDS [Time frame: seven days after birth]
Secondary outcome measures (6)
- intraventricular hemorrhage(IVH) [Time frame: before discharge or 36 weeks' gestational age]
- air leak [Time frame: at 36 weeks' gestational age or before discharge from hospital]
- periventricular leukomalacia(PVL) [Time frame: at 36 weeks' gestational age or before discharge from hospital]
- necrotizing enterocolitis(NEC) [Time frame: at 36 weeks' gestational age or before discharge from hospital]
- patent ductus arteriosis(PDA) [Time frame: at 36 weeks' gestational age or before discharge from hospital]
- late-onset sepsis(LOS) [Time frame: at 36 weeks' gestational age or before discharge from hospital]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Chen — Chongqing
Identifiers
NCT: NCT04777760 · surfactant for NRDS and ARDS