RDSPhase 3RDSNCT01265589
Intratracheal Vitamin A Administration With Surfactant for Newborn Respiratory Distress Syndrome
A Phase 3 study testing surfactant and surfactant+vitamin A in people with RDS and Infant, Newborn, run by Third Military Medical University at 1 site in China.
Trial summary
To research the effect of vitamin A to newborn respiratory distress syndrome by intratracheal administration with surfactant. Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- RDS, Infant, Newborn, Vitamin A
- What is being tested?
- surfactant and surfactant+vitamin A
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jan 2012to Dec 2013
- Phase
- Phase 3
- 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 Up to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1.Newborn infants with birth weight >500 gm.
- 2.Gestational age >24 completed weeks.
- 3.Intention to manage the infant with non-invasive respiratory support (i.e. no endotracheal tube), where either: 1) the infant is within the first 7 days of life and has never been intubated or has received less than 24 hours of total cumulative intubated respiratory support; 2)the infant is within the first 28 days of life, has been managed with intubated respiratory support for 24 hours or more and is a candidate for extubation followed by non-invasive respiratory support.
- 4.No known lethal congenital anomaly or genetic syndromes.
- 5.Signed parental informed consent
Who cannot join
- 1.Considered non-viable by clinician (decision not to administer effective therapies)
- 2.Life-threatening congenital abnormalities including congenital heart disease (excluding patent ductus arteriosis)
- 3.Infants known to require surgical treatment
- 4.Abnormalities of the upper and lower airways
- 5.Neuromuscular disorders
- 6.Infants who are >28 days old and continue to require mechanical ventilation with an endotracheal tube
Trial locations and contacts
1 site in 1 country.
China1 site
Deaprtment of Pediatrics, Daping Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, 400042
About this study
To research the effect of vitamin A to newborn respiratory distress syndrome by intratracheal administration with surfactant.
Read the detailed description
Chronic lung disease (CLD) of prematurity is the major cause of long-term disability of extremely LBW (ELBW) premature infants, and it is the most cost consumptive disease in Neonatal Intensive Care Unit graduates. Vitamin A plays an important role in the development of premature lung. Nevertheless, premature infants are prone to vitamin A deficiency. Oral supplementation of vitamin A does not alter the incidence of CLD in ELBW infants. Intramuscular administration of vitamin A reduced the incidence of CLD. The treatment is considered painful and this way is not routinely practiced. Vitamin A is systemically bioavailable after intratracheal administration with surfactant in an animal model of newborn respiratory distress.
- Conditions
- RDS, Infant, Newborn, Vitamin A, Surfactant
- Being tested
- surfactant, surfactant+vitamin A
- Keywords
- RDS, Infant, newborn, Vitamin A, Surfactant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surfactantDrug
Intratracheal Surfactant Administration without Vitamin A for Newborn Respiratory Distress Syndrome
surfactant+vitamin ADrug
Intratracheal Surfactant Administration with Vitamin A for Newborn Respiratory Distress Syndrome
| Study group | Role | What they receive |
|---|---|---|
| I=surfactant | Placebo comparator | Intratracheal Surfactant Administration without Vitamin A for Newborn Respiratory Distress Syndrome Receives: Drug: surfactant |
| II=surfactant+vitamin A | Experimental | Intratracheal Surfactant Administration with Vitamin A for Newborn Respiratory Distress Syndrome Receives: Drug: surfactant+vitamin A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intratracheal Vitamin A Administration with Surfactant for Newborn Respiratory Distress Syndrome
get the date of infants' reflects with Intratracheal Vitamin A Administration
Measured: 1 year
Secondary outcomes (1)
Overall clinical outcomes at Newborn Infants With Respiratory Distress Syndrome
analysis the date and drow a conclusion
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2010 (estimated)
- Study startJan 2012
- Primary completionDec 2012 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RDSStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Military Medical University
- Sponsor type
- University, hospital or other
- Investigators
- Yuan Shi, MD, Study director, Department of Pediatrics, Daping Hospital, Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01265589
- Sponsor's protocol ID
- 2011001
- Acronym
- RDS
- Status last verified
- Nov 2010
- First submitted
- 3 Dec 2010
- Last updated
- 26 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intratracheal Vitamin A Administration With Surfactant for Newborn Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT01265589
- Acronym / sponsor ID
- RDS / 2011001
- Conditions
- RDS, Infant, Newborn, Vitamin A, Surfactant
- Keywords
- RDS, Infant, newborn, Vitamin A, Surfactant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Third Military Medical UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 23 Dec 2010 (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.
To research the effect of vitamin A to newborn respiratory distress syndrome by intratracheal administration with surfactant.
Detailed description
Chronic lung disease (CLD) of prematurity is the major cause of long-term disability of extremely LBW (ELBW) premature infants, and it is the most cost consumptive disease in Neonatal Intensive Care Unit graduates. Vitamin A plays an important role in the development of premature lung. Nevertheless, premature infants are prone to vitamin A deficiency. Oral supplementation of vitamin A does not alter the incidence of CLD in ELBW infants. Intramuscular administration of vitamin A reduced the incidence of CLD. The treatment is considered painful and this way is not routinely practiced. Vitamin A is systemically bioavailable after intratracheal administration with surfactant in an animal model of newborn respiratory distress.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I=surfactant | Placebo comparator | Drug: surfactantIntratracheal Surfactant Administration without Vitamin A for Newborn Respiratory Distress Syndrome |
| II=surfactant+vitamin A | Experimental | Drug: surfactant+vitamin AIntratracheal Surfactant Administration with Vitamin A for Newborn Respiratory Distress Syndrome |
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 1.Newborn infants with birth weight >500 gm.
- 2.Gestational age >24 completed weeks.
- 3.Intention to manage the infant with non-invasive respiratory support (i.e. no endotracheal tube), where either: 1) the infant is within the first 7 days of life and has never been intubated or has received less than 24 hours of total cumulative intubated respiratory support; 2)the infant is within the first 28 days of life, has been managed with intubated respiratory support for 24 hours or more and is a candidate for extubation followed by non-invasive respiratory support.
- 4.No known lethal congenital anomaly or genetic syndromes.
- 5.Signed parental informed consent
Key exclusion criteria (6 listed)
- 1.Considered non-viable by clinician (decision not to administer effective therapies)
- 2.Life-threatening congenital abnormalities including congenital heart disease (excluding patent ductus arteriosis)
- 3.Infants known to require surgical treatment
- 4.Abnormalities of the upper and lower airways
- 5.Neuromuscular disorders
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 |
|---|---|---|
| surfactantIntratracheal Surfactant Administration without Vitamin A for Newborn Respiratory Distress Syndrome | Drug | I=surfactant |
| surfactant+vitamin AIntratracheal Surfactant Administration with Vitamin A for Newborn Respiratory Distress Syndrome | Drug | II=surfactant+vitamin A |
Primary outcome
Intratracheal Vitamin A Administration with Surfactant for Newborn Respiratory Distress Syndrome
Time frame: 1 year
get the date of infants' reflects with Intratracheal Vitamin A Administration
1 secondary outcome
Overall clinical outcomes at Newborn Infants With Respiratory Distress Syndrome
Time frame: 13 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2011.
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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.
Yuan Shi, MD study director
Department of Pediatrics, Daping Hospital, 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?
A Phase 3 study testing surfactant and surfactant+vitamin A in people with RDS and Infant, Newborn, run by 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 5 inclusion and 6 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 26 Jul 2011. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Heqiang Sun (+86 15310303739, sunheqiang1@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intratracheal Vitamin A Administration with Surfactant for Newborn Respiratory Distress Syndrome (time frame: 1 year). 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 26 Jul 2011.