NCT01265589

Intratracheal Vitamin A Administration With Surfactant for Newborn Respiratory Distress Syndrome

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Third Military Medical University · Academic / Other
• Sex: All
• Age: 28 Days
• Healthy volunteers: Not accepted

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.

Conditions

• RDS
• Infant, Newborn
• Vitamin A
• Surfactant

Interventions

Type	Name	Description
DRUG	surfactant	Intratracheal Surfactant Administration without Vitamin A for Newborn Respiratory Distress Syndrome
DRUG	surfactant+vitamin A	Intratracheal Surfactant Administration with Vitamin A for Newborn Respiratory Distress Syndrome

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-12-01
• Completion: 2013-12-01
• First posted: 2010-12-23
• Last updated: 2011-07-26

Locations

1 site across 1 country: China