SurfactantNCT03479450
Surfactant for Neonatal Respiratory Distress Syndrome at High Altitude Areas:a Prospective Cohort Study
An observational study of Surfactant, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
Trial summary
The traditional concept believes that the etiology of neonatal respiratory distress syndrome (RDS) is immature development of lung,especially the surfactant synthesis system,and RDS is still one of the major causes of mortality and morbidity in newborns, especially premature infants.In recent years, using pulmonary… Read more about this study
- Who is it for?
- Ages 10 minutes to 1 day
- Conditions the study is for
- Surfactant
- What is being tested?
- surfactant
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2020to 1 Dec 2022
- Phase
- Observational
- 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 10 minutes to 1 day
- All sexes
- Child
Study population: the preterm infants less than 37 weeks and diagnosed with NRDS were included in the study.
Who may be able to join
- the preterm infants less than 37 weeks were included in the study;diagnosed with NRDS
Who cannot join
- parents' rejecting to join;major congenital abnormalities
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Pediatrics, Daping Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, 400042
Juan Ma, physician, 18680887330, zoe330@163.com
About this study
The traditional concept believes that the etiology of neonatal respiratory distress syndrome (RDS) is immature development of lung,especially the surfactant synthesis system,and RDS is still one of the major causes of mortality and morbidity in newborns, especially premature infants.In recent years, using pulmonary surfactant replacement therapy (PS treatment) in the treatment of respiratory distress syndrome (RDS) is a major breakthrough in neonatal medicine.Combined with clinical practice and experience,and through Meta analysis of related randomized controlled trials (RCTs),it confirms that natural surfactant treatment can reduce mortality,the incidence of pulmonary air leaks (pneumothorax and interstitial lung emphysema),and the incidence of bronchopulmonary dysplasia (BPD) or 28-day-old mortality.For RDS in preterm infants whose gestation is <35 weeks ,surfactant replacement therapy is also more effective than in nearly term and full term infants.Therefore, in the analysis of cases of different gestational age groups,the investigators should focus on the study of premature infants cases.Due to less relevant research for using PS treatment to cure newborn RDS in high altitude area,this retrospective study conducts statistics and analysis of recently three-year cases in some hospital of high altitude area,to explore the treatment effect of the high altitude region and the impact of altitude on the treatment.
Read the detailed description
in order to explore feasibility and efficacy for PS treatment of newborn RDS in high-altitude area ,and its efficacy at different altitudes, the investigators conduct a multi-center retrospective study of RDS cases in Qinghai and Tibet these two high-altitude area,and use RDS cases under the unique conditions to do statistics and analysis.
- Conditions
- Surfactant
- Being tested
- surfactant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surfactantDrug
surfactant is given when neonatal respiratory distress syndrome is diagnosed
What is being measured
The primary outcome is the main question the study is designed to answer.
bronchopulmonary dysplasia(BPD)
the incidence of BPD in infants with neonatal neonatal RDS
Measured: before discharge or 36 weeks' gestational age
death
the incidence of BPD in infants with neonatal RDS
Measured: before discharge or 36 weeks' gestational age
Secondary outcomes (2)
intraventriclular hemorrhage(IVH)
the incidence of IVH in infants with neonatal RDS
Measured: before discharge or 36 weeks' gestational age
necrotizing enterocolitis(NEC)
the incidence of NEC in infants with neonatal RDS
Measured: before discharge or 36 weeks' gestational age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start1 Mar 2020
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurfactantStudies 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
- 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
- Collaborators
- the first people hospital of Tibet autonomous region, the second people hospital of Lasa, the first people hospital of Shigatse, the first people hospital of Lasa, the people hospital of Linzhi, the people hospital of Laqu
- Responsible party
- Principal investigator, Ma Juan, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03479450
- Sponsor's protocol ID
- surfactant for NRDS
- Status last verified
- Feb 2021
- First submitted
- 18 Mar 2018
- Last updated
- 17 Feb 2021
- 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 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surfactant for Neonatal Respiratory Distress Syndrome at High Altitude Areas:a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03479450
- Acronym / sponsor ID
- surfactant for NRDS
- Conditions
- Surfactant
- Study type
- Observational
- 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
- Collaborators
- the first people hospital of Tibet autonomous region, the second people hospital of Lasa, the first people hospital of Shigatse, the first people hospital of Lasa, the people hospital of Linzhi, the people hospital of Laqu
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 27 Mar 2018 (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.
The traditional concept believes that the etiology of neonatal respiratory distress syndrome (RDS) is immature development of lung,especially the surfactant synthesis system,and RDS is still one of the major causes of mortality and morbidity in newborns, especially premature infants.In recent years, using pulmonary surfactant replacement therapy (PS treatment) in the treatment of respiratory distress syndrome (RDS) is a major breakthrough in neonatal medicine.Combined with clinical practice and experience,and through Meta analysis of related randomized controlled trials (RCTs),it confirms that natural surfactant treatment can reduce mortality,the incidence of pulmonary air leaks (pneumothorax and interstitial lung emphysema),and the incidence of bronchopulmonary dysplasia (BPD) or 28-day-old mortality.For RDS in preterm infants whose gestation is <35 weeks ,surfactant replacement therapy is also more effective than in nearly term and full term infants.Therefore, in the analysis of cases of different gestational age groups,the investigators should focus on the study of premature infants cases.Due to less relevant research for using PS treatment to cure newborn RDS in high altitude area,this retrospective study conducts statistics and analysis of recently three-year cases in some hospital of high altitude area,to explore the treatment effect of the high altitude region and the impact of altitude on the treatment.
Detailed description
in order to explore feasibility and efficacy for PS treatment of newborn RDS in high-altitude area ,and its efficacy at different altitudes, the investigators conduct a multi-center retrospective study of RDS cases in Qinghai and Tibet these two high-altitude area,and use RDS cases under the unique conditions to do statistics and analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 minutes to 1 day
- Sex
- All
- Age groups
- Child
- Study population
- the preterm infants less than 37 weeks and diagnosed with NRDS were included in the study.
Key inclusion criteria (1 listed)
- the preterm infants less than 37 weeks were included in the study;diagnosed with NRDS
Key exclusion criteria (1 listed)
- parents' rejecting to join;major congenital 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 |
|---|---|---|
| surfactantsurfactant is given when neonatal respiratory distress syndrome is diagnosed | Drug | – |
Primary outcome
bronchopulmonary dysplasia(BPD)
Time frame: before discharge or 36 weeks' gestational age
the incidence of BPD in infants with neonatal neonatal RDS
death
Time frame: before discharge or 36 weeks' gestational age
the incidence of BPD in infants with neonatal RDS
2 secondary outcomes
intraventriclular hemorrhage(IVH)
Time frame: before discharge or 36 weeks' gestational age
necrotizing enterocolitis(NEC)
Time frame: before discharge or 36 weeks' gestational age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
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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?
An observational study of Surfactant, 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 1 inclusion and 1 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 17 Feb 2021. 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 (13508300283, petshi530@vip.163.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: before discharge or 36 weeks' gestational age). 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 17 Feb 2021.