Intratracheal Vitamin A Administration With Surfactant for Newborn Respiratory Distress Syndrome

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01265589
• Date of registration: 03/12/2010
• Primary sponsor: Third Military Medical University
• Public title: Intratracheal Vitamin A Administration With Surfactant for Newborn Respiratory Distress Syndrome RDS
• Scientific title: Intratracheal Vitamin A Administration With Surfactant for Newborn Respiratory Distress Syndrome
• Date of first enrolment: January 2012
• Target sample size: 100
• Recruitment status: Not yet recruiting
• URL: http://clinicaltrials.gov/show/NCT01265589
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

China

Contacts

• Name: Heqiang Sun

• Name: Yuan Shi, MD
• Affiliation: Department of Pediatrics, Daping Hospital, Third Military Medical University

Key inclusion & exclusion criteria

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



Age minimum: N/A
Age maximum: 28 Days
Gender: Both

Health Condition(s) or Problem(s) studied

Infant, Newborn

RDS

Surfactant

Vitamin A

Intervention(s)

Drug: surfactant

Drug: surfactant+vitamin A

Primary Outcome(s)

Intratracheal Vitamin A Administration with Surfactant for Newborn Respiratory Distress Syndrome [Time Frame: 1 year]

Secondary Outcome(s)

Overall clinical outcomes at Newborn Infants With Respiratory Distress Syndrome [Time Frame: 13 months]

Secondary ID(s)

2011001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors