Surfactant for Neonatal Respiratory Distress Syndrome(NRDS) and Neonatal Acute Respiratory Distre… (NCT04777760) | Clinical Trial Compass
RecruitingNot Applicable
Surfactant for Neonatal Respiratory Distress Syndrome(NRDS) and Neonatal Acute Respiratory Distress Syndrome(NARDS)
China400 participantsStarted 2021-01-01
Plain-language 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.
Who can participate
Age range
1 Minute – 24 Hours
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
bronchopulmonary dysplasia(BPD)
Timeframe: at 36 weeks' gestational age or before discharge from hospital
2
death
Timeframe: at 36 weeks' gestational age or before discharge from hospital
3
BPD and/or death
Timeframe: at 36 weeks' gestational age or before discharge from hospital
4
the predictive powers of one dose of surfactant to diagnose NRDS
Timeframe: seven days after birth
5
the predictive powers of two and more doses of surfactant to diagnose NARDS
Timeframe: seven days after birth
Trial details
NCT IDNCT04777760
SponsorDaping Hospital and the Research Institute of Surgery of the Third Military Medical University