Respiratory Distress Syndrome, NewbornNCT04984057
Optimal Dose of Surfactant for Preterm Infants With Respiratory Distress Syndrome
A study testing PS is stopped when the pressure is equal between bPDA and aPDA. and PS is given according to the 2019 European RDS management guideline in people with Respiratory Distress Syndrome, Newborn and Patent Ductus Arteriosus, 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 (RDS), exogenous pulmonary surfactant(PS) replacement therapy is one of the most important therapeutic breakthrough to reduce neonatal incidences of bronchopulmonary dysplasia(BPD) and/or death. But not all preterm infants with RDS can be beneficial. Read more about this study
- Who is it for?
- Ages 1 minute to 12 hours
- Conditions the study is for
- Respiratory Distress Syndrome, Newborn, Patent Ductus Arteriosus, Bronchopulmonary Dysplasia
- What is being tested?
- PS is stopped when the pressure is equal between bPDA and aPDA. and PS is given according to the 2019 European RDS management guideline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2021to 31 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 1 minute to 12 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- gestation age less than or equal to 32 weeks
- PS is needed
Who cannot join
- main congenital abnormalities
- parents' refusal or quit
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Children's Hospital of Chongqing Medical University
Chongqing
Chen Long, PhD,MD, 13883559467 ext. 86, neuroclong@126.com
About this study
Official title: Optimal Dose of Surfactant for Preterm Infants With Respiratory Distress Syndrome(RDS)
In preterm infants with neonatal respiratory distress syndrome (RDS), exogenous pulmonary surfactant(PS) replacement therapy is one of the most important therapeutic breakthrough to reduce neonatal incidences of bronchopulmonary dysplasia(BPD) and/or death. But not all preterm infants with RDS can be beneficial. Otherwise, the international neonatal acute RDS (NARDS) collaborative group provides the first consensus definition for NARDS in 2017. And whether or not PS being beneficial in preterm infants with NARDS remains unknown.
Read the detailed description
To date, the optimal dose of PS is inconsistent, although the recommended dose of PS is given in the 2019 update guideline. PS is not recommended to adult and pediatric ARDS. Systematic review indicates that PS does not reduce the incidences of BPD and death in infants with meconium aspiration syndrome(MAS, a subtype of NARDS). A reasonable speculation is that preterm infants with NARDS do not benefit from PS. And the speculation can explain why not all preterm infants with RDS can be beneficial from PS. In the era of pre-NARDS, the preterm infants fulfilling the definition of NARDS may have been considered as RDS in the first three days after birth.
Meantime, the dose of PS given to infants with NARDS remains unknown. the aim of the present study is to assess the optimal dose of PS. the control group: PS is given according to the European RDS management guideline in 2019 edition. The study group: PS is stopped when the pressure is equal between before patent ductus arteriosus(bPDA) and after PDA(aPDA). the primary outcomes are the closure rate of PDA within 7 days, the incidence of BPD and/or death.
- Conditions
- Respiratory Distress Syndrome, Newborn, Patent Ductus Arteriosus, Bronchopulmonary Dysplasia, Preterm
- Being tested
- PS is stopped when the pressure is equal between bPDA and aPDA., PS is given according to the 2019 European RDS management guideline
- Medical subject headings
- Respiratory Distress Syndrome, Newborn, Ductus Arteriosus, Patent, Bronchopulmonary Dysplasia, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PS is stopped when the pressure is equal between bPDA and aPDA.Drug
PS is given and stopped when the pressure is equal between bPDA and aPDA. the pressure is measured using ultrasound
PS is given according to the 2019 European RDS management guidelineDrug
PS is given according to the 2019 European RDS management guideline
| Study group | Role | What they receive |
|---|---|---|
| PS is stopped when the pressure is equal between bPDA and aPDA | Experimental | PS is given and stopped when the pressure is equal between bPDA and aPDA. the pressure is measured using ultrasound Receives: Drug: PS is stopped when the pressure is equal between bPDA and aPDA. |
| PS is given according to the 2019 European RDS management guideline | Active comparator | PS is given according to the 2019 European RDS management guideline Receives: Drug: PS is given according to the 2019 European RDS management guideline |
What is being measured
The primary outcome is the main question the study is designed to answer.
the size of PDA
the size of PDA is zero
Measured: within 7 days after birth
BPD and/or death
the BPD and/or death is diagnosed when the included infants remain needing oxygen at 36 week's gestational age
Measured: at 36 week's gestational age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start1 Aug 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress Syndrome, NewbornStudies 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
- 300 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
- NCT04984057
- Sponsor's protocol ID
- Surfactant dose
- Status last verified
- Oct 2022
- First submitted
- 24 Jul 2021
- Last updated
- 14 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Dose of Surfactant for Preterm Infants With Respiratory Distress Syndrome(RDS)
- ClinicalTrials.gov ID
- NCT04984057
- Acronym / sponsor ID
- Surfactant dose
- Conditions
- Respiratory Distress Syndrome, Newborn, Patent Ductus Arteriosus, Bronchopulmonary Dysplasia, Preterm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 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 Aug 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 30 Jul 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 (RDS), exogenous pulmonary surfactant(PS) replacement therapy is one of the most important therapeutic breakthrough to reduce neonatal incidences of bronchopulmonary dysplasia(BPD) and/or death. But not all preterm infants with RDS can be beneficial. Otherwise, the international neonatal acute RDS (NARDS) collaborative group provides the first consensus definition for NARDS in 2017. And whether or not PS being beneficial in preterm infants with NARDS remains unknown.
Detailed description
To date, the optimal dose of PS is inconsistent, although the recommended dose of PS is given in the 2019 update guideline. PS is not recommended to adult and pediatric ARDS. Systematic review indicates that PS does not reduce the incidences of BPD and death in infants with meconium aspiration syndrome(MAS, a subtype of NARDS). A reasonable speculation is that preterm infants with NARDS do not benefit from PS. And the speculation can explain why not all preterm infants with RDS can be beneficial from PS. In the era of pre-NARDS, the preterm infants fulfilling the definition of NARDS may have been considered as RDS in the first three days after birth.
Meantime, the dose of PS given to infants with NARDS remains unknown. the aim of the present study is to assess the optimal dose of PS. the control group: PS is given according to the European RDS management guideline in 2019 edition. The study group: PS is stopped when the pressure is equal between before patent ductus arteriosus(bPDA) and after PDA(aPDA). the primary outcomes are the closure rate of PDA within 7 days, the incidence of BPD and/or death.
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 |
|---|---|---|
| PS is stopped when the pressure is equal between bPDA and aPDA | Experimental | Drug: PS is stopped when the pressure is equal between bPDA and aPDA.PS is given and stopped when the pressure is equal between bPDA and aPDA. the pressure is measured using ultrasound |
| PS is given according to the 2019 European RDS management guideline | Active comparator | Drug: PS is given according to the 2019 European RDS management guidelinePS is given according to the 2019 European RDS management guideline |
Who may qualify
- Ages
- 1 minute to 12 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- gestation age less than or equal to 32 weeks
- PS is needed
Key exclusion criteria (2 listed)
- main congenital abnormalities
- parents' refusal or quit
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 |
|---|---|---|
| PS is stopped when the pressure is equal between bPDA and aPDA.PS is given and stopped when the pressure is equal between bPDA and aPDA. the pressure is measured using ultrasound | Drug | PS is stopped when the pressure is equal between bPDA and aPDA |
| PS is given according to the 2019 European RDS management guidelinePS is given according to the 2019 European RDS management guideline | Drug | PS is given according to the 2019 European RDS management guideline |
Primary outcome
the size of PDA
Time frame: within 7 days after birth
the size of PDA is zero
BPD and/or death
Time frame: at 36 week's gestational age
the BPD and/or death is diagnosed when the included infants remain needing oxygen at 36 week's gestational age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2022.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PS is stopped when the pressure is equal between bPDA and aPDA. and PS is given according to the 2019 European RDS management guideline in people with Respiratory Distress Syndrome, Newborn and Patent Ductus Arteriosus, 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 2 inclusion and 2 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 14 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 Chen Long, PhD,MD (13883559467 ext. 86, neuroclong@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the size of PDA (time frame: within 7 days after birth). The study lists 2 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 14 Oct 2022.