Respiratory Distress SyndromeNCT04777760
Surfactant for Neonatal Respiratory Distress Syndrome(NRDS) and Neonatal Acute Respiratory Distress Syndrome(NARDS)
An observational study of Respiratory Distress Syndrome and Preterm Birth, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 minute to 24 hours
- Conditions the study is for
- Respiratory Distress Syndrome, Preterm Birth, Acute Respiratory Distress Syndrome
- What is being tested?
- one dose of surfactant replacement and two and more doses of surfactant replacement
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 24 hours
- All sexes
- Child
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
Who may be able to join
- 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
Who cannot join
- one of the following criteria will be needed
- major congenital anomalies
- chromosomal abnormalities
- upper respiratory tract abnormalities
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chen
Chongqing, Chongqing Municipality, 400042
Chen Long, MD,PhD, +8613883559467, neuroclong@126.com
About this study
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.
Read the 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.
- Conditions
- Respiratory Distress Syndrome, Preterm Birth, Acute Respiratory Distress Syndrome, Surfactant Dysfunction
- Being tested
- one dose of surfactant replacement, two and more doses of surfactant replacement
- Medical subject headings
- Respiratory Distress Syndrome, Premature Birth, Surfactant Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
one dose of surfactant replacementDrug
the preterm infants diagnosed with NRDS and/or NARDS will be administrated with only one dose of surfactant
two and more doses of surfactant replacementDrug
the preterm infants diagnosed with NRDS and/or NARDS will be administrated with two and more doses of surfactant
| Study group | Role | What they receive |
|---|---|---|
| one dose of surfactant | the preterm infants diagnosed with NRDS and/or NARDS will be administrated with only one dose of surfactant Receives: Drug: one dose of surfactant replacement | |
| 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 Receives: Drug: two and more doses of surfactant replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
bronchopulmonary dysplasia(BPD)
the preterm infants will be diagnosed with BPD
Measured: at 36 weeks' gestational age or before discharge from hospital
death
the preterm infants die
Measured: at 36 weeks' gestational age or before discharge from hospital
BPD and/or death
the preterm infants will be diagnosed with BPD and/or death
Measured: at 36 weeks' gestational age or before discharge from hospital
the predictive powers of one dose of surfactant to diagnose NRDS
the sensitivity and accuracy of one dose of surfactant to diagnose NRDS
Measured: seven days after birth
the predictive powers of two and more doses of surfactant to diagnose NARDS
the sensitivity and accuracy of two and more doses of surfactant to diagnose NARDS
Measured: seven days after birth
Secondary outcomes (6)
intraventricular hemorrhage(IVH)
the preterm infants will be diagnosed with IVH
Measured: before discharge or 36 weeks' gestational age
air leak
the preterm infants will be diagnosed with air leak
Measured: at 36 weeks' gestational age or before discharge from hospital
periventricular leukomalacia(PVL)
the preterm infants will be diagnosed with PVL
Measured: at 36 weeks' gestational age or before discharge from hospital
necrotizing enterocolitis(NEC)
the preterm infants will be diagnosed with NEC
Measured: at 36 weeks' gestational age or before discharge from hospital
patent ductus arteriosis(PDA)
the preterm infants will be diagnosed with PDA
Measured: at 36 weeks' gestational age or before discharge from hospital
late-onset sepsis(LOS)
the preterm infants will be diagnosed with LOS
Measured: at 36 weeks' gestational age or before discharge from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start1 Jan 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Chongqing Medical University
- Responsible party
- Principal investigator, Chen Long,MD, Children's Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04777760
- Sponsor's protocol ID
- surfactant for NRDS and ARDS
- Status last verified
- Jun 2025
- First submitted
- 26 Feb 2021
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: the data will be accessed after two years of study accomplishment
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surfactant for Neonatal Respiratory Distress Syndrome(NRDS) and Neonatal Acute Respiratory Distress Syndrome(NARDS)
- ClinicalTrials.gov ID
- NCT04777760
- Acronym / sponsor ID
- surfactant for NRDS and ARDS
- Conditions
- Respiratory Distress Syndrome, Preterm Birth, Acute Respiratory Distress Syndrome, Surfactant Dysfunction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityUniversity, hospital or other
- Collaborators
- Children's Hospital of Chongqing Medical University
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| one dose of surfactant | – | Drug: one dose of surfactant replacementthe preterm infants diagnosed with NRDS and/or NARDS will be administrated with only one dose of surfactant |
| two and more doses of surfactant | – | Drug: two and more doses of surfactant replacementthe preterm infants diagnosed with NRDS and/or NARDS will be administrated with two and more doses of surfactant |
Who may qualify
- Ages
- 1 minute to 24 hours
- Sex
- All
- Age groups
- Child
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- one of the following criteria will be needed
- major congenital anomalies
- chromosomal abnormalities
- upper respiratory tract abnormalities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| one dose of surfactant replacementthe preterm infants diagnosed with NRDS and/or NARDS will be administrated with only one dose of surfactant | Drug | one dose of surfactant |
| two and more doses of surfactant replacementthe 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 |
Primary outcome
bronchopulmonary dysplasia(BPD)
Time frame: at 36 weeks' gestational age or before discharge from hospital
the preterm infants will be diagnosed with BPD
death
Time frame: at 36 weeks' gestational age or before discharge from hospital
the preterm infants die
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
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
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
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Individual participant dataSharing planned: Yes. the data will be accessed after two years of study accomplishment
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Distress Syndrome and Preterm Birth, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chen Long, MD, PhD (+8613883559467, neuroclong@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bronchopulmonary dysplasia(BPD) (time frame: at 36 weeks' gestational age or before discharge from hospital). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.