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

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ClinicalTrials.gov Identifier: NCT01265589
Recruitment Status : Unknown
Verified November 2010 by Third Military Medical University.
Recruitment status was:  Not yet recruiting
First Posted : December 23, 2010
Last Update Posted : July 26, 2011
Sponsor:
Information provided by:

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  (Clinical Trial)
Estimated 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 : January 2012
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 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


Outcome Measures

Primary Outcome Measures :
  1. Intratracheal Vitamin A Administration with Surfactant for Newborn Respiratory Distress Syndrome [ Time Frame: 1 year ]
    get the date of infants' reflects with Intratracheal Vitamin A Administration


Secondary Outcome Measures :
  1. Overall clinical outcomes at Newborn Infants With Respiratory Distress Syndrome [ Time Frame: 13 months ]
    analysis the date and drow a conclusion


Eligibility Criteria

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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01265589


Contacts
Contact: Heqiang Sun +86 15310303739 sunheqiang1@sina.com
Contact: Yuan Shi, MD +86 23 68757731 petshi530@vip.163.com

Locations
China, Chongqing
Deaprtment of Pediatrics, Daping Hospital, Third Military Medical University
Chongqing, Chongqing, China, 400042
Sponsors and Collaborators
Third Military Medical University
Investigators
Study Director: Yuan Shi, MD Department of Pediatrics, Daping Hospital, Third Military Medical University
More Information

Responsible Party: Yuan Shi and Heqiang Sun, Daping Hospital, Third Military Medical University
ClinicalTrials.gov Identifier: NCT01265589     History of Changes
Other Study ID Numbers: 2011001
First Posted: December 23, 2010    Key Record Dates
Last Update Posted: July 26, 2011
Last Verified: November 2010

Keywords provided by Third Military Medical University:
RDS
Infant, newborn
Vitamin A
Surfactant

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Hyaline Membrane Disease
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Vitamins
Vitamin A
Retinol palmitate
Pulmonary Surfactants
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Respiratory System Agents