Intratracheal Vitamin A Administration With Surfactant for Newborn Respiratory Distress Syndrome — RDS  

Infant, Newborn Clinical Trial

Official title: Intratracheal Vitamin A Administration With Surfactant for Newborn Respiratory Distress Syndrome

Status Not yet recruiting

Clinical Trial Summary

To research the effect of vitamin A to newborn respiratory distress syndrome by intratracheal administration with surfactant.

Clinical Trial 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyaline Membrane Disease
• Infant, Newborn
• RDS
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Surfactant
• Vitamin A

• NCT number: NCT01265589
• Study type: Interventional
• Source: Third Military Medical University
• Contact: Heqiang Sun
• Phone: +86 15310303739
• Email: sunheqiang1@sina.com
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: January 2012
• Completion date: December 2013