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

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

Study Overview

• Status: Unknown
• Conditions: Infant, Newborn; RDS; Vitamin A; Surfactant
• Intervention / Treatment: Drug: surfactant; Drug: surfactant+vitamin A

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400042
      • Deaprtment of Pediatrics, Daping Hospital, Third Military Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 4 weeks (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Third Military Medical University
• Investigators: Study Director: Yuan Shi, MD, Department of Pediatrics, Daping Hospital, Third Military Medical University

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Anticipated): December 1, 2012
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: December 3, 2010
• First Submitted That Met QC Criteria: December 22, 2010
• First Posted (Estimate): December 23, 2010

Study Record Updates

• Last Update Posted (Estimate): July 26, 2011
• Last Update Submitted That Met QC Criteria: July 25, 2011
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Keywords: Surfactant; RDS; Vitamin A; Infant, newborn
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Hyaline Membrane Disease; Physiological Effects of Drugs; Micronutrients; Respiratory System Agents; Vitamins; Pulmonary Surfactants; Vitamin A
• Other Study ID Numbers: 2011001