Infant, Newborn, RDS, Surfactant, Vitamin A
Conditions
Keywords
RDS, Infant, newborn, Vitamin A, Surfactant
Brief summary
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.
Interventions
DRUGsurfactant
Intratracheal Surfactant Administration without Vitamin A for Newborn Respiratory Distress Syndrome
DRUGsurfactant+vitamin A
Intratracheal Surfactant Administration with Vitamin A for Newborn Respiratory Distress Syndrome
Sponsors
Third Military Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 28 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intratracheal Vitamin A Administration with Surfactant for Newborn Respiratory Distress Syndrome | 1 year | get the date of infants' reflects with Intratracheal Vitamin A Administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall clinical outcomes at Newborn Infants With Respiratory Distress Syndrome | 13 months | analysis the date and drow a conclusion |
Countries
China
Contacts
Primary ContactHeqiang Sun
Backup ContactYuan Shi, MD
Outcome results
None listed