Infant, Newborn, NRDSNCT03385863
Efficacy of Surfactant and Perinatal Risk Factors in NRDS With Different Gestational Ages
An observational study of Infant, Newborn, NRDS, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
Trial summary
Since exogenous surfactant replacement therapy was first used to prevent neonatal respiratory distress syndrome (NRDS)，it has become the main method of treatment of NRDS. However, in some infants, death is inevitable despite intensive care and surfactant replacement therapy, especially in near-term and term infants. Read more about this study
- Who is it for?
- Ages 1 hour to 28 days
- Conditions the study is for
- Infant, Newborn, NRDS
- What is being tested?
- Surfactant, Pulmonary，Curosurf and Perinatal risk factors of NRDS
- Type of treatment
- Injection or infusion
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2011to 1 Mar 2018
- 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 hour to 28 days
- All sexes
- No healthy volunteers
- Child
Study population: Infants with RDS who received surfactant therapy were recruited from 24 hospitals between January 2011 and December 2016.
Who may be able to join
- Infants with RDS who received surfactant therapy were recruited between January 2011 and December 2016.
Who cannot join
- Infants were excluded if they had any congeni- tal malformation, inherited metabolic abnormality, intrauterine infection, Rh/Rh incompatibility, pneumonia, pulmonary hypertension, meconium aspiration syndrome, or asphyxia.
Trial locations and contacts
1 site in 1 country.
Yuan Shi, Doctor contact
China1 site, 1 recruiting
- Recruiting
Department of pediatrics, Daping Hospital, The Third Military Medical University
Chongqing, Chongqing Municipality, 400042
Li Wang, MD, 008613527499258, liwang8771@126.com
About this study
Official title: A Multicenter Clinical Study on the Comparison of the Efficacy of Surfactant and Perinatal Risk Factors in NRDS With Different Gestational Ages
Since exogenous surfactant replacement therapy was first used to prevent neonatal respiratory distress syndrome (NRDS)，it has become the main method of treatment of NRDS. However, in some infants, death is inevitable despite intensive care and surfactant replacement therapy, especially in near-term and term infants. The first goal of our study is to compare the therapeutic effect of pulmonary surfactant of infants at different gestational ages and to investigate whether exogenous surfactant replacement therapy is effective for all newborns with RDS. The second goal of our study is to further analyze the risk factors and causes of RDS in early preterm infants and near term/term infants.
- Conditions
- Infant, Newborn, NRDS
- Being tested
- Surfactant, Pulmonary，Curosurf, Perinatal risk factors of NRDS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surfactant, Pulmonary，CurosurfDrug
All NRDS were given an early endotracheal infusion of Curosuf, with an initial dose of 200mg/kg, and if the condition needed to be repeated. Compare the therapeutic effect of pulmonary surfactant of infants at different gestational ages and to investigate whether exogenous surfactant replacement therapy is effective for all newborns with RDS.
Perinatal risk factors of NRDSOther
Compare the perinatal risk factors that were closely related to NRDS between early preterm infants with RDS and near term/term infants with RDS.
| Study group | Role | What they receive |
|---|---|---|
| early preterm infants with RDS | gestational age<34 weeks Receives: Drug: Surfactant, Pulmonary，Curosurf; Other: Perinatal risk factors of NRDS | |
| near term infants with RDS | 34 weeks≤gestational age< 37 weeks Receives: Drug: Surfactant, Pulmonary，Curosurf; Other: Perinatal risk factors of NRDS | |
| term infants with RDS | Gestational age ≥ 37 weeks Receives: Drug: Surfactant, Pulmonary，Curosurf; Other: Perinatal risk factors of NRDS |
What is being measured
The primary outcome is the main question the study is designed to answer.
therapeutic effect of pulmonary surfactant of infants at different gestational ages
Measured: January 1，2011 to December 30，2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2017
- Study start1 Jan 2011
- Primary completion30 Dec 2016
- Study completion1 Mar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, Newborn, 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
- 1,500 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, Li Wang, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Investigators
- Li Wang, Doctor, Principal investigator, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03385863
- Sponsor's protocol ID
- 02333669
- Status last verified
- Dec 2017
- First submitted
- 21 Dec 2017
- Last updated
- 29 Dec 2017
- Results posted
- No
- 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 29 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Clinical Study on the Comparison of the Efficacy of Surfactant and Perinatal Risk Factors in NRDS With Different Gestational Ages
- ClinicalTrials.gov ID
- NCT03385863
- Acronym / sponsor ID
- 02333669
- Conditions
- Infant, Newborn, NRDS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 30 Dec 2016 (actual)
- Study completion
- 1 Mar 2018 (estimated)
- First posted
- 29 Dec 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.
Since exogenous surfactant replacement therapy was first used to prevent neonatal respiratory distress syndrome (NRDS)，it has become the main method of treatment of NRDS. However, in some infants, death is inevitable despite intensive care and surfactant replacement therapy, especially in near-term and term infants. The first goal of our study is to compare the therapeutic effect of pulmonary surfactant of infants at different gestational ages and to investigate whether exogenous surfactant replacement therapy is effective for all newborns with RDS. The second goal of our study is to further analyze the risk factors and causes of RDS in early preterm infants and near term/term infants.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| early preterm infants with RDS | – | Drug: Surfactant, Pulmonary，Curosurf, Other: Perinatal risk factors of NRDSgestational age<34 weeks |
| near term infants with RDS | – | Drug: Surfactant, Pulmonary，Curosurf, Other: Perinatal risk factors of NRDS34 weeks≤gestational age< 37 weeks |
| term infants with RDS | – | Drug: Surfactant, Pulmonary，Curosurf, Other: Perinatal risk factors of NRDSGestational age ≥ 37 weeks |
Who may qualify
- Ages
- 1 hour to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants with RDS who received surfactant therapy were recruited from 24 hospitals between January 2011 and December 2016.
Key inclusion criteria (1 listed)
- Infants with RDS who received surfactant therapy were recruited between January 2011 and December 2016.
Key exclusion criteria (1 listed)
- Infants were excluded if they had any congeni- tal malformation, inherited metabolic abnormality, intrauterine infection, Rh/Rh incompatibility, pneumonia, pulmonary hypertension, meconium aspiration syndrome, or asphyxia.
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, Pulmonary，CurosurfAll NRDS were given an early endotracheal infusion of Curosuf, with an initial dose of 200mg/kg, and if the condition needed to be repeated. Compare the therapeutic effect of pulmonary surfactant of infants at different gestational ages and to investigate whether exogenous surfactant replacement therapy is effective for all newborns with RDS. | Drug | early preterm infants with RDS, near term infants with RDS, term infants with RDS |
| Perinatal risk factors of NRDSCompare the perinatal risk factors that were closely related to NRDS between early preterm infants with RDS and near term/term infants with RDS. | Other | early preterm infants with RDS, near term infants with RDS, term infants with RDS |
Primary outcome
therapeutic effect of pulmonary surfactant of infants at different gestational ages
Time frame: January 1，2011 to December 30，2016
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Infant, Newborn, 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
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.
Yuan Shi, Doctor contact
Li Wang, Doctor principal investigator
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
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 Infant, Newborn, NRDS, 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 29 Dec 2017. 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 Li Wang, Doctor (008613527499258, liwang8771@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
therapeutic effect of pulmonary surfactant of infants at different gestational ages (time frame: January 1，2011 to December 30，2016). 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 29 Dec 2017.