Nasal Continuous Positive Airway Pressure,NCT01996670
Early NCPAP Before Surfactant Treatment in Very Preterm Infants With RDS
An observational study of Nasal Continuous Positive Airway Pressure, and Preterm Infants,, run by Xiangya Hospital of Central South University.
Trial summary
We hypothesis a period of early NCPAP before surfactant treatment is effective for treating RDS and preventing BPD in very premature infants. Read more about this study
- Who is it for?
- Ages 30 minutes to 2 hours
- Conditions the study is for
- Nasal Continuous Positive Airway Pressure,, Preterm Infants,, Surfactant Treatment,
- How many people
- 683 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to Dec 2012
- 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 30 minutes to 2 hours
- All sexes
- No healthy volunteers
- Child
Study population: inborn infants at 26-32 weeks gestation with RDS, whom received NCPAP as the initial treatment, followed by surfactant treatment within 24 h after birth
Who may be able to join
- All enrolled infants were able to breathe at 5 min of age, had evidence of respiratory distress, unable to receive surfactant therapy, and were administrated with early NCPAP as the initial treatment
Who cannot join
- Exclusion criteria were endotracheal intubation for resuscitation or insufficient respiratory drive, died in the first 24 hours after birth, known genetic disorders, potentially life-threatening conditions unrelated to prematurity, and premature rupture of membranes (PROM) for >3 weeks.
About this study
We hypothesis a period of early NCPAP before surfactant treatment is effective for treating RDS and preventing BPD in very premature infants.
- Conditions
- Nasal Continuous Positive Airway Pressure,, Preterm Infants,, Surfactant Treatment,, Respiratory Distress Syndrome,, Bronchopulmonary Dysplasia
- Medical subject headings
- Respiratory Distress Syndrome, Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| <2h group | Not described | |
| 2-4h group | Not described | |
| >4h group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
death or bronchopulmonary dysplasia
Measured: 24 hours after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2013 (estimated)
- Study startJan 2007
- Primary completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal Continuous Positive Airway Pressure,Studies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 683 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huiyi Huo, Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01996670
- Sponsor's protocol ID
- huohuiyi20131121
- Other IDs
- huo20131121
- Status last verified
- Jan 2007
- First submitted
- 21 Nov 2013
- Last updated
- 27 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early NCPAP Before Surfactant Treatment in Very Preterm Infants With RDS
- ClinicalTrials.gov ID
- NCT01996670
- Acronym / sponsor ID
- huohuiyi20131121
- Conditions
- Nasal Continuous Positive Airway Pressure,, Preterm Infants,, Surfactant Treatment,, Respiratory Distress Syndrome,, Bronchopulmonary Dysplasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 683 participants (actual)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Dec 2012 (actual)
- First posted
- 27 Nov 2013 (estimated)
- 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.
We hypothesis a period of early NCPAP before surfactant treatment is effective for treating RDS and preventing BPD in very premature infants.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| <2h group | – | – |
| 2-4h group | – | – |
| >4h group | – | – |
Who may qualify
- Ages
- 30 minutes to 2 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- inborn infants at 26-32 weeks gestation with RDS, whom received NCPAP as the initial treatment, followed by surfactant treatment within 24 h after birth
Key inclusion criteria (1 listed)
- All enrolled infants were able to breathe at 5 min of age, had evidence of respiratory distress, unable to receive surfactant therapy, and were administrated with early NCPAP as the initial treatment
Key exclusion criteria (1 listed)
- Exclusion criteria were endotracheal intubation for resuscitation or insufficient respiratory drive, died in the first 24 hours after birth, known genetic disorders, potentially life-threatening conditions unrelated to prematurity, and premature rupture of membranes (PROM) for >3 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
death or bronchopulmonary dysplasia
Time frame: 24 hours after birth
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 Nov 2013.
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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.
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 Nasal Continuous Positive Airway Pressure, and Preterm Infants,, run by Xiangya Hospital of Central South 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 Nov 2013. 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?
death or bronchopulmonary dysplasia (time frame: 24 hours after birth). 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 Nov 2013.