Clinical trial NCT01265589: Intratracheal Vitamin A Administration With Surfactant for Newborn Respiratory Distress Syndrome
Official title: Intratracheal Vitamin A Administration With Surfactant for Newborn Respiratory Distress Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: RDS
Infant, Newborn
Vitamin A
Surfactant
Keywords: RDS
Infant, newborn
Vitamin A
Surfactant
Lead sponsor: Third Military Medical University
Sponsor class: OTHER
First posted: 2010-12-23
Enrollment: 100
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Intratracheal Vitamin A Administration with Surfactant for Newborn Respiratory Distress Syndrome
timeFrame: 1 year
Secondary outcomes:
measure: Overall clinical outcomes at Newborn Infants With Respiratory Distress Syndrome
timeFrame: 13 months
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Deaprtment of Pediatrics, Daping Hospital, Third Military Medical University
state: Chongqing
Study officials:
affiliation: Department of Pediatrics, Daping Hospital, Third Military Medical University
name: Yuan Shi, MD
role: STUDY_DIRECTOR
References: