Intratracheal Vitamin A Administration With Surfactant for Newborn Respiratory Distress Syndrome

Infant, Newborn Clinical Trial

— RDS  

Official title:

Intratracheal Vitamin A Administration With Surfactant for Newborn Respiratory Distress Syndrome

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01265589
• Other study ID #: 2011001
• Status: Not yet recruiting
• Phase: Phase 3
• First received: December 3, 2010
• Last updated: July 25, 2011
• Start date: January 2012
• Est. completion date: December 2013

Study information

• Verified date: November 2010
• Source: Third Military Medical University
• Contact: Heqiang Sun
• Phone: +86 15310303739
• Email: sunheqiang1[@]sina.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationChina: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 28 Days

Eligibility

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

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

Intervention

Drug:
• surfactant
Intratracheal Surfactant Administration without Vitamin A for Newborn Respiratory Distress Syndrome
• surfactant+vitamin A
Intratracheal Surfactant Administration with Vitamin A for Newborn Respiratory Distress Syndrome

Locations

Country	Name	City	State
China	Deaprtment of Pediatrics, Daping Hospital, Third Military Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Third Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intratracheal Vitamin A Administration with Surfactant for Newborn Respiratory Distress Syndrome	get the date of infants' reflects with Intratracheal Vitamin A Administration	1 year	Yes
Secondary	Overall clinical outcomes at Newborn Infants With Respiratory Distress Syndrome	analysis the date and drow a conclusion	13 months	Yes