ARDSNCT03217162
Surfactant for Neonate With Acute Respiratory Distress Syndrome (ARDS)
A study testing surfactant combined with mechanical ventilation (MV) and mechanical ventilation (MV) in people with ARDS and RDS, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
Trial summary
Acute respiratory distress syndrome (ARDS) in neonates has been defined, the role of surfactant is not clear. This study aimed to determine whether ARDS neonate would benefit from surfactant when oxygenation deteriorated on mechanical ventilation and to identify any potential risk factors related to mortality. Read more about this study
- Who is it for?
- Ages 30 minutes to 28 days
- Conditions the study is for
- ARDS, RDS, Surfactant
- What is being tested?
- surfactant combined with mechanical ventilation (MV) and mechanical ventilation (MV)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2017to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 minutes to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- infant less than 28 days
- diagnosis of ARDS or RDS or both
- informed parental consent has been obtained
Who cannot join
- major congenital malformations or complex congenital heart disease or chromosomal abnormalities
- transferred out of the neonatal intensive care unit without treatment
- upper respiratory tract abnormalities
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of neonatology, Children's hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400014
Juan Ma, physician, 18680887330, zoe330@163.com
About this study
Official title: Surfactant for Neonate With Acute Respiratory Distress Syndrome (ARDS): A Randomized Controlled Trial
Acute respiratory distress syndrome (ARDS) in neonates has been defined, the role of surfactant is not clear. This study aimed to determine whether ARDS neonate would benefit from surfactant when oxygenation deteriorated on mechanical ventilation and to identify any potential risk factors related to mortality.
Read the detailed description
To date, surfactant is not recommended to adult and pediatric ARDS. Meantime, systematic review indicates that surfactant does not demonstrate statistically significant beneficial effects on reducing the mortality and the rate of bronchopulmonary dysplasia(BPD) in term and late preterm infants with meconium aspiration syndrome. Therefore, a reasonable speculation is that preterm infants with ARDS do not benefit from one dose of surfactant. And the speculation can explain why not all preterm infants with respiratory distress can be beneficial from surfactant. In the era of pre-ARDS, the preterm infants fulfilling the definition of ARDS may have been considered as respiratory distress syndrome (ARDS) in the first three days after birth.
According to the diagnostic criteria of neonatal ARDS, a key procedure for diagnosis of neonatal ARDS is to exclude the newborn infants with RDS. But no detailed procedures are available to differentiate RDS from ARDS according the guideline of european RDS and definition of neonatal ARDS.
Therefore, there are two aim in the present study. 1. to proposel a new definition of RDS; 2. to assess the beneficial effects of surfactant on neonatal ARDS.
- Conditions
- ARDS, RDS, Surfactant
- Being tested
- surfactant combined with mechanical ventilation (MV), mechanical ventilation (MV)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surfactant combined with mechanical ventilation (MV)Drug
surfactant combined with mechanical ventilation (MV) is given to the infant with ARDS
mechanical ventilation (MV)Drug
mechanical ventilation (MV) is given to the infant with ARDS
| Study group | Role | What they receive |
|---|---|---|
| surfactant combined with mechanical ventilation | Experimental | surfactant is given to the infant with ARDS. Receives: Drug: surfactant combined with mechanical ventilation (MV) |
| mechanical ventilation | Active comparator | mechanical ventilation is given to the infant with ARDS. Receives: Drug: mechanical ventilation (MV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
death
neonates died
Measured: at 36 weeks' gestational age or before discharge from hospital
bronchopulmonary dysplasia(BPD)
neonates were diagnosed with BPD
Measured: at 36 weeks' gestational age or before discharge from hospital
BPD and/or death
neonates were diagnosed with BPD and/or death
Measured: at 36 weeks' gestational age or before discharge from hospital
Secondary outcomes (5)
Bayley Scales of Infant Development
the survival are assessed by Bayley Scales of Infant Development
Measured: at 2 months old and 2 years old
haemodynamically significant patent ductusarteriosus (hsPDA)
neonates were diagnosed with hsPDA
Measured: at 36 weeks' gestational age or before discharge from hospital
retinopathy of prematurity (ROP)> 2nd stages
neonates were diagnosed with ROP> 2nd stages
Measured: at 36 weeks' gestational age or before discharge from hospital
necrotizing enterocolitis (NEC) ≥ 2nd stages
neonates were diagnosed with NEC ≥ 2nd stages
Measured: at 36 weeks' gestational age or before discharge from hospital
intraventricular hemorrhage(IVH)>2nd grades
neonates were diagnosed with IVH >2nd grades
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 posted13 Jul 2017
- Study start1 Aug 2017
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDSStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 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
- Responsible party
- Principal investigator, Ma Juan, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Investigators
- Shi Yuan, PhD,MD, Study director, Children's Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03217162
- Sponsor's protocol ID
- surfactant for ARDS
- Status last verified
- Oct 2022
- First submitted
- 12 Jul 2017
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surfactant for Neonate With Acute Respiratory Distress Syndrome (ARDS): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03217162
- Acronym / sponsor ID
- surfactant for ARDS
- Conditions
- ARDS, RDS, Surfactant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 13 Jul 2017 (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.
Acute respiratory distress syndrome (ARDS) in neonates has been defined, the role of surfactant is not clear. This study aimed to determine whether ARDS neonate would benefit from surfactant when oxygenation deteriorated on mechanical ventilation and to identify any potential risk factors related to mortality.
Detailed description
To date, surfactant is not recommended to adult and pediatric ARDS. Meantime, systematic review indicates that surfactant does not demonstrate statistically significant beneficial effects on reducing the mortality and the rate of bronchopulmonary dysplasia(BPD) in term and late preterm infants with meconium aspiration syndrome. Therefore, a reasonable speculation is that preterm infants with ARDS do not benefit from one dose of surfactant. And the speculation can explain why not all preterm infants with respiratory distress can be beneficial from surfactant. In the era of pre-ARDS, the preterm infants fulfilling the definition of ARDS may have been considered as respiratory distress syndrome (ARDS) in the first three days after birth.
According to the diagnostic criteria of neonatal ARDS, a key procedure for diagnosis of neonatal ARDS is to exclude the newborn infants with RDS. But no detailed procedures are available to differentiate RDS from ARDS according the guideline of european RDS and definition of neonatal ARDS.
Therefore, there are two aim in the present study. 1. to proposel a new definition of RDS; 2. to assess the beneficial effects of surfactant on neonatal ARDS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| surfactant combined with mechanical ventilation | Experimental | Drug: surfactant combined with mechanical ventilation (MV)surfactant is given to the infant with ARDS. |
| mechanical ventilation | Active comparator | Drug: mechanical ventilation (MV)mechanical ventilation is given to the infant with ARDS. |
Who may qualify
- Ages
- 30 minutes to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- infant less than 28 days
- diagnosis of ARDS or RDS or both
- informed parental consent has been obtained
Key exclusion criteria (3 listed)
- major congenital malformations or complex congenital heart disease or chromosomal abnormalities
- transferred out of the neonatal intensive care unit without treatment
- 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 |
|---|---|---|
| surfactant combined with mechanical ventilation (MV)surfactant combined with mechanical ventilation (MV) is given to the infant with ARDS | Drug | surfactant combined with mechanical ventilation |
| mechanical ventilation (MV)mechanical ventilation (MV) is given to the infant with ARDS | Drug | mechanical ventilation |
Primary outcome
death
Time frame: at 36 weeks' gestational age or before discharge from hospital
neonates died
bronchopulmonary dysplasia(BPD)
Time frame: at 36 weeks' gestational age or before discharge from hospital
neonates were diagnosed with BPD
BPD and/or death
Time frame: at 36 weeks' gestational age or before discharge from hospital
neonates were diagnosed with BPD and/or death
5 secondary outcomes
Bayley Scales of Infant Development
Time frame: at 2 months old and 2 years old
haemodynamically significant patent ductusarteriosus (hsPDA)
Time frame: at 36 weeks' gestational age or before discharge from hospital
retinopathy of prematurity (ROP)> 2nd stages
Time frame: at 36 weeks' gestational age or before discharge from hospital
necrotizing enterocolitis (NEC) ≥ 2nd stages
Time frame: at 36 weeks' gestational age or before discharge from hospital
intraventricular hemorrhage(IVH)>2nd grades
Time frame: at 36 weeks' gestational age or before discharge from hospital
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
- Individual participant dataSharing planned: Undecided
Related trials for ARDS
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruitingObservational study
Development and Multicenter Validation of an Explainable System for Neonatal ARDS-Compatible Phenotyping
Acute Respiratory Distress Syndrome
RecruitingObservational study
Assessment of Blood Viscosity in ARDS (Acute Respiratory Distress Syndrome)
ARDS
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Recruiting
REspiratory MEchanics for Delivering Individualised Exogenous Surfactant
Respiratory Distress Syndrome in Premature Infant
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. This study is not recruiting at the moment.
Shi Yuan, PhD,MD study director
Children's Hospital of Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surfactant combined with mechanical ventilation (MV) and mechanical ventilation (MV) in people with ARDS and RDS, 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 25 Oct 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ma Juan, MD (13883559467, 476679422@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
death (time frame: at 36 weeks' gestational age or before discharge from hospital). The study lists 3 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 25 Oct 2022.