Intratracheal Vitamin A Administration With Surfactant for Newborn Respiratory Distress Syndrome

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

Detailed Description
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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.

Official Title
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Intratracheal Vitamin A Administration With Surfactant for Newborn Respiratory Distress Syndrome

Conditions
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RDS, Infant, Newborn, Vitamin A, Surfactant

Intervention / Treatment
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* Drug: surfactant
* Drug: surfactant+vitamin A


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: I=surfactant<br>Intratracheal Surfactant Administration without Vitamin A for Newborn Respiratory Distress Syndrome | Drug: surfactant<br>* Intratracheal Surfactant Administration without Vitamin A for Newborn Respiratory Distress Syndrome<br>|
| Experimental: II=surfactant+vitamin A<br>Intratracheal Surfactant Administration with Vitamin A for Newborn Respiratory Distress Syndrome | Drug: surfactant+vitamin A<br>* Intratracheal Surfactant Administration with Vitamin A for Newborn Respiratory Distress Syndrome<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intratracheal Vitamin A Administration with Surfactant for Newborn Respiratory Distress Syndrome | get the date of infants' reflects with Intratracheal Vitamin A Administration | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall clinical outcomes at Newborn Infants With Respiratory Distress Syndrome | analysis the date and drow a conclusion | 13 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RDS, Infant, newborn, Vitamin A, Surfactant