Intratracheal Vitamin A Administration With Surfactant for Newborn Respiratory Distress Syndrome

Phase 3

• Conditions: RDS; Infant, Newborn; Vitamin A; Surfactant
• Interventions: Drug: surfactant; Drug: surfactant+vitamin A

• Registration Number: NCT01265589
• Lead Sponsor: Third Military Medical University

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.

Study Timeline

• Status Verified: 2010-11
• Study First Submitted: 2010-12-03
• Study First Submitted QC: 2010-12-22
• Study First Posted: 2010-12-23
• Last Update Submitted: 2011-07-25
• Last Update Posted: 2011-07-26
• Study Start: 2012-01
• Primary Completion: 2012-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
I=surfactant	surfactant	Intratracheal Surfactant Administration without Vitamin A for Newborn Respiratory Distress Syndrome
II=surfactant+vitamin A	surfactant+vitamin A	Intratracheal Surfactant Administration with Vitamin A for Newborn Respiratory Distress Syndrome

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Overall clinical outcomes at Newborn Infants With Respiratory Distress Syndrome	13 months	analysis the date and drow a conclusion

Trial Locations

Locations (1)

Deaprtment of Pediatrics, Daping Hospital, Third Military Medical University; 🇨🇳 Chongqing, Chongqing, China