Intratracheal Vitamin A Administration With Surfactant for Newborn Respiratory Distress Syndrome

• Status: Unknown status
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Third Military Medical University
• Treatments: Pulmonary Surfactants; Retinol palmitate; Vitamin A; Vitamins

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