Intratracheal Vitamin A Administration With Surfactant for Newborn Respiratory Distress Syndrome (RDS)
This study is not yet open for participant recruitment.
Verified November 2010 by Third Military Medical University
Sponsor:
Third Military Medical University
Information provided by:
Third Military Medical University
ClinicalTrials.gov Identifier:
NCT01265589
First received: December 3, 2010
Last updated: July 25, 2011
Last verified: November 2010
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Purpose
To research the effect of vitamin A to newborn respiratory distress syndrome by intratracheal administration with surfactant.
| Condition | Intervention | Phase |
|---|---|---|
|
RDS Infant, Newborn Vitamin A Surfactant |
Drug: surfactant Drug: surfactant+vitamin A |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Intratracheal Vitamin A Administration With Surfactant for Newborn Respiratory Distress Syndrome |
Resource links provided by NLM:
Further study details as provided by Third Military Medical University:
Primary Outcome Measures:
- Intratracheal Vitamin A Administration with Surfactant for Newborn Respiratory Distress Syndrome [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]get the date of infants' reflects with Intratracheal Vitamin A Administration
Secondary Outcome Measures:
- Overall clinical outcomes at Newborn Infants With Respiratory Distress Syndrome [ Time Frame: 13 months ] [ Designated as safety issue: Yes ]analysis the date and drow a conclusion
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: I=surfactant
Intratracheal Surfactant Administration without Vitamin A for Newborn Respiratory Distress Syndrome
|
Drug: surfactant
Intratracheal Surfactant Administration without Vitamin A for Newborn Respiratory Distress Syndrome
Other Name: surfactant
|
|
Experimental: II=surfactant+vitamin A
Intratracheal Surfactant Administration with Vitamin A for Newborn Respiratory Distress Syndrome
|
Drug: surfactant+vitamin A
Intratracheal Surfactant Administration with Vitamin A for Newborn Respiratory Distress Syndrome
Other Name: surfactant+vitamin A
|
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.
Eligibility| Ages Eligible for Study: | up to 28 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01265589
Contacts
| Contact: Heqiang Sun | +86 15310303739 | sunheqiang1@sina.com |
| Contact: Yuan Shi, MD | +86 23 68757731 | petshi530@vip.163.com |
Locations
| China, Chongqing | |
| Deaprtment of Pediatrics, Daping Hospital, Third Military Medical University | |
| Chongqing, Chongqing, China, 400042 | |
Sponsors and Collaborators
Third Military Medical University
Investigators
| Study Director: | Yuan Shi, MD | Department of Pediatrics, Daping Hospital, Third Military Medical University |
More Information
No publications provided
| Responsible Party: | Yuan Shi and Heqiang Sun, Daping Hospital, Third Military Medical University |
| ClinicalTrials.gov Identifier: | NCT01265589 History of Changes |
| Other Study ID Numbers: | 2011001 |
| Study First Received: | December 3, 2010 |
| Last Updated: | July 25, 2011 |
| Health Authority: | United States: Food and Drug Administration China: Ministry of Health |
Keywords provided by Third Military Medical University:
|
RDS Infant, newborn Vitamin A Surfactant |
Additional relevant MeSH terms:
|
Hyaline Membrane Disease Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Lung Diseases Respiratory Tract Diseases Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases Pulmonary Surfactants Vitamin A Vitamins Retinol palmitate |
Respiratory System Agents Therapeutic Uses Pharmacologic Actions Micronutrients Growth Substances Physiological Effects of Drugs Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Anticarcinogenic Agents Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 16, 2013