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Intratracheal Vitamin A Administration With Surfactant for Newborn Respiratory Distress Syndrome

Information source: Third Military Medical University
ClinicalTrials.gov processed this data on November 27, 2014
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

Page last updated: November 27, 2014

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