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

Third Military Medical University

Status and phase: Unknown; Phase 3

Conditions: Infant, Newborn; Surfactant; Vitamin A; RDS

Treatments: Drug: surfactant; Drug: surfactant+vitamin A

Study type: Interventional

Funder types: Other

Identifiers

NCT01265589

2011001

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: Under 28 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups, including a placebo group

I=surfactant

Placebo Comparator group

Description:

Intratracheal Surfactant Administration without Vitamin A for Newborn Respiratory Distress Syndrome

Treatment:

Drug: surfactant

II=surfactant+vitamin A

Experimental group

Description:

Intratracheal Surfactant Administration with Vitamin A for Newborn Respiratory Distress Syndrome

Treatment:

Drug: surfactant+vitamin A