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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Third Military Medical University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Third Military Medical University
ClinicalTrials.gov Identifier:
NCT01265589
First received: December 3, 2010
Last updated: July 25, 2011
Last verified: November 2010
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intratracheal Vitamin A Administration With Surfactant for Newborn Respiratory Distress Syndrome

Resource links provided by NLM:


Further study details as provided by Third Military Medical University:

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


Secondary Outcome Measures:
  • Overall clinical outcomes at Newborn Infants With Respiratory Distress Syndrome [ Time Frame: 13 months ] [ Designated as safety issue: Yes ]
    analysis the date and drow a conclusion


Estimated Enrollment: 100
Study Start Date: January 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: surfactant
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
Other Name: 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.

  Eligibility

Ages Eligible for Study:   up to 28 Days
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 3, 2010
Last Updated: July 25, 2011
Health Authority: United States: Food and Drug Administration
China: Ministry of Health

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

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

ClinicalTrials.gov processed this record on October 21, 2014