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

Primary Purpose

RDS, Infant, Newborn, Vitamin A

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
surfactant
surfactant+vitamin A
Sponsored by
Third Military Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for RDS focused on measuring RDS, Infant, newborn, Vitamin A, Surfactant

Eligibility Criteria

undefined - 28 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Deaprtment of Pediatrics, Daping Hospital, Third Military Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

I=surfactant

II=surfactant+vitamin A

Arm Description

Intratracheal Surfactant Administration without Vitamin A for Newborn Respiratory Distress Syndrome

Intratracheal Surfactant Administration with Vitamin A for Newborn Respiratory Distress Syndrome

Outcomes

Primary Outcome Measures

Intratracheal Vitamin A Administration with Surfactant for Newborn Respiratory Distress Syndrome
get the date of infants' reflects with Intratracheal Vitamin A Administration

Secondary Outcome Measures

Overall clinical outcomes at Newborn Infants With Respiratory Distress Syndrome
analysis the date and drow a conclusion

Full Information

First Posted
December 3, 2010
Last Updated
July 25, 2011
Sponsor
Third Military Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01265589
Brief Title
Intratracheal Vitamin A Administration With Surfactant for Newborn Respiratory Distress Syndrome
Acronym
RDS
Official Title
Intratracheal Vitamin A Administration With Surfactant for Newborn Respiratory Distress Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Third Military Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
RDS, Infant, Newborn, Vitamin A, Surfactant
Keywords
RDS, Infant, newborn, Vitamin A, Surfactant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
I=surfactant
Arm Type
Placebo Comparator
Arm Description
Intratracheal Surfactant Administration without Vitamin A for Newborn Respiratory Distress Syndrome
Arm Title
II=surfactant+vitamin A
Arm Type
Experimental
Arm Description
Intratracheal Surfactant Administration with Vitamin A for Newborn Respiratory Distress Syndrome
Intervention Type
Drug
Intervention Name(s)
surfactant
Intervention Description
Intratracheal Surfactant Administration without Vitamin A for Newborn Respiratory Distress Syndrome
Intervention Type
Drug
Intervention Name(s)
surfactant+vitamin A
Intervention Description
Intratracheal Surfactant Administration with Vitamin A for Newborn Respiratory Distress Syndrome
Primary Outcome Measure Information:
Title
Intratracheal Vitamin A Administration with Surfactant for Newborn Respiratory Distress Syndrome
Description
get the date of infants' reflects with Intratracheal Vitamin A Administration
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Overall clinical outcomes at Newborn Infants With Respiratory Distress Syndrome
Description
analysis the date and drow a conclusion
Time Frame
13 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heqiang Sun
Phone
+86 15310303739
Email
sunheqiang1@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yuan Shi, MD
Phone
+86 23 68757731
Email
petshi530@vip.163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuan Shi, MD
Organizational Affiliation
Department of Pediatrics, Daping Hospital, Third Military Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Deaprtment of Pediatrics, Daping Hospital, Third Military Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China

12. IPD Sharing Statement

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Intratracheal Vitamin A Administration With Surfactant for Newborn Respiratory Distress Syndrome

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