Intratracheal Vitamin A Administration With Surfactant for Newborn Respiratory Distress Syndrome
Information source: Third Military Medical University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: RDS; Infant, Newborn; Vitamin A; Surfactant
Intervention: surfactant (Drug); surfactant+vitamin A (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: Third Military Medical University Official(s) and/or principal investigator(s): Yuan Shi, MD, Study Director, Affiliation: Department of Pediatrics, Daping Hospital, Third Military Medical University
Overall contact: Heqiang Sun, Phone: +86 15310303739, Email: sunheqiang1@sina.com
Summary
To research the effect of vitamin A to newborn respiratory distress syndrome by
intratracheal administration with surfactant.
Clinical Details
Official title: Intratracheal Vitamin A Administration With Surfactant for Newborn Respiratory Distress Syndrome
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Intratracheal Vitamin A Administration with Surfactant for Newborn Respiratory Distress Syndrome
Secondary outcome: Overall clinical outcomes at Newborn Infants With Respiratory Distress Syndrome
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
Minimum age: N/A.
Maximum age: 28 Days.
Gender(s): Both.
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
Locations and Contacts
Heqiang Sun, Phone: +86 15310303739, Email: sunheqiang1@sina.com
Deaprtment of Pediatrics, Daping Hospital, Third Military Medical University, Chongqing, Chongqing 400042, China
Additional Information
Starting date: January 2012
Last updated: July 25, 2011
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