NRDSNCT03440333
Pulmonary Surfactant(PS) Therapy at High Altitude Area
An observational study of NRDS and Surfactant, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University.
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[1].In recent years, using pulmonary… Read more about this study
- Who is it for?
- Ages 1 minute to 12 hours
- Conditions the study is for
- NRDS, Surfactant
- What is being tested?
- surfactant
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 31 Dec 2017
- 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 1 minute to 12 hours
- All sexes
- Child
Study population: the preterm infants less than 37 weeks were included in the study
Who may be able to join
- diagnosed with respiratory distress syndrome(RDS)
Who cannot join
- major congenital abnormalities
About this study
Official title: A Multicenter Study of Pulmonary Surfactant(PS) Therapy in the Treatment of Neonatal Acute Respiratory Distress Syndrome(RDS) at High Altitude Area
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[1].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 [2].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
- NRDS, Surfactant
- Being tested
- surfactant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surfactantDrug
Pulmonary surfactant was administrated if the baby was diagnosed with respiratory distress syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
the intubation rate
the effect of PS treatment for NRDS
Measured: one week
the incidence of NRDS in different altitudes
different altitudes may result in different rate of NRDS
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start1 Jan 2015
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NRDSStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 400 participants (actual)
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, Shannan People's Hospital, the people hospital of Changdu, the people hospital of Ali, the second people hospital of Tibet autonomous region, Women and Children Hospital of Qinghai Province
- 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
- NCT03440333
- Sponsor's protocol ID
- pulmonary surfactant(PS)
- Status last verified
- Feb 2018
- First submitted
- 3 Feb 2018
- Last updated
- 27 Feb 2018
- 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 27 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study of Pulmonary Surfactant(PS) Therapy in the Treatment of Neonatal Acute Respiratory Distress Syndrome(RDS) at High Altitude Area
- ClinicalTrials.gov ID
- NCT03440333
- Acronym / sponsor ID
- pulmonary surfactant(PS)
- Conditions
- NRDS, Surfactant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- 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, Shannan People's Hospital, the people hospital of Changdu, the people hospital of Ali, the second people hospital of Tibet autonomous region, Women and Children Hospital of Qinghai Province
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 22 Feb 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[1].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 [2].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
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 minute to 12 hours
- Sex
- All
- Age groups
- Child
- Study population
- the preterm infants less than 37 weeks were included in the study
Key inclusion criteria (1 listed)
- diagnosed with respiratory distress syndrome(RDS)
Key exclusion criteria (1 listed)
- 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 |
|---|---|---|
| surfactantPulmonary surfactant was administrated if the baby was diagnosed with respiratory distress syndrome | Drug | – |
Primary outcome
the intubation rate
Time frame: one week
the effect of PS treatment for NRDS
the incidence of NRDS in different altitudes
Time frame: one week
different altitudes may result in different rate of NRDS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2018.
Related trials for NRDS
Not yet recruitingObservational study
Impact of Delayed Cord Clamping and Minimally Invasive Surfactant Administration on Outcomes in Premature Infants Less Than 30 Weeks Gestation
NRDS
RecruitingObservational study
Surfactant for Neonatal Respiratory Distress Syndrome(NRDS) and Neonatal Acute Respiratory Distress Syndrome(NARDS)
Respiratory Distress Syndrome, Preterm Birth
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of NRDS and Surfactant, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University.
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: finished, as of the sponsor's last update on 27 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the intubation rate (time frame: one week). 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 27 Feb 2018.