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

Sponsor

Third Military Medical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT01265589

Collaborator

(none)

100

Enrollment

Location

Arms

Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
RDS Infant, Newborn Vitamin A Surfactant	Drug: surfactant Drug: surfactant+vitamin A	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Intratracheal Vitamin A Administration With Surfactant for Newborn Respiratory Distress Syndrome

Study Start Date :

Jan 1, 2012

Anticipated Primary Completion Date :

Dec 1, 2012

Anticipated Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: I=surfactant Intratracheal Surfactant Administration without Vitamin A for Newborn Respiratory Distress Syndrome	Drug: surfactant Intratracheal Surfactant Administration without Vitamin A for Newborn Respiratory Distress Syndrome
Experimental: II=surfactant+vitamin A Intratracheal Surfactant Administration with Vitamin A for Newborn Respiratory Distress Syndrome	Drug: surfactant+vitamin A Intratracheal Surfactant Administration with Vitamin A for Newborn Respiratory Distress Syndrome

Arm

Intervention/Treatment

Placebo Comparator: I=surfactant

Intratracheal Surfactant Administration without Vitamin A for Newborn Respiratory Distress Syndrome

Drug: surfactant

Intratracheal Surfactant Administration without Vitamin A for Newborn Respiratory Distress Syndrome

Experimental: II=surfactant+vitamin A

Intratracheal Surfactant Administration with Vitamin A for Newborn Respiratory Distress Syndrome

Drug: surfactant+vitamin A

Intratracheal Surfactant Administration with Vitamin A for Newborn Respiratory Distress Syndrome

Outcome Measures

Primary Outcome Measures

Intratracheal Vitamin A Administration with Surfactant for Newborn Respiratory Distress Syndrome [1 year]
get the date of infants' reflects with Intratracheal Vitamin A Administration

Secondary Outcome Measures

Overall clinical outcomes at Newborn Infants With Respiratory Distress Syndrome [13 months]
analysis the date and drow a conclusion

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 28 Days

Sexes Eligible for Study:

All

Accepts 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