Intratracheal Vitamin A Administration With Surfactant for Newborn Respiratory Distress Syndrome

NCT01265589 | Unknown Phase 3 DMC

• 1 other identifier: 2011001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

RDS; Infant, Newborn; Vitamin A; Surfactant

Keywords

RDS; Infant, newborn; Vitamin A; Surfactant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Overall clinical outcomes at Newborn Infants With Respiratory Distress Syndrome

  13 months

Study Arms (2)

I=surfactant

PLACEBO COMPARATOR

Intratracheal Surfactant Administration without Vitamin A for Newborn Respiratory Distress Syndrome

Drug: surfactant

II=surfactant+vitamin A

EXPERIMENTAL

Intratracheal Surfactant Administration with Vitamin A for Newborn Respiratory Distress Syndrome

Drug: surfactant+vitamin A

Interventions

surfactant DRUG

Intratracheal Surfactant Administration without Vitamin A for Newborn Respiratory Distress Syndrome

I=surfactant

surfactant+vitamin A DRUG

Intratracheal Surfactant Administration with Vitamin A for Newborn Respiratory Distress Syndrome

II=surfactant+vitamin A

Eligibility Criteria

• Age: Up to 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Newborn infants with birth weight \>500 gm.
• Gestational age \>24 completed weeks.
• 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.
• No known lethal congenital anomaly or genetic syndromes.
• Signed parental informed consent

You may not qualify if:

• Considered non-viable by clinician (decision not to administer effective therapies)
• Life-threatening congenital abnormalities including congenital heart disease (excluding patent ductus arteriosis)
• Infants known to require surgical treatment
• Abnormalities of the upper and lower airways
• Neuromuscular disorders
• Infants who are \>28 days old and continue to require mechanical ventilation with an endotracheal tube

Sponsors & Collaborators

• Third Military Medical University: lead

Study Sites (1)

Deaprtment of Pediatrics, Daping Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, 400042, China

Location

MeSH Terms

Interventions

Surface-Active Agents

Intervention Hierarchy (Ancestors)

Specialty Uses of Chemicals; Chemical Actions and Uses

Study Officials

• Yuan Shi, MD

  Department of Pediatrics, Daping Hospital, Third Military Medical University

  STUDY DIRECTOR

Central Study Contacts

Heqiang Sun

CONTACT

+86 15310303739; sunheqiang1@sina.com

Yuan Shi, MD

CONTACT

+86 23 68757731; petshi530@vip.163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 3, 2010
• First Posted: December 23, 2010
• Study Start: January 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2013
• Last Updated: July 26, 2011

Record last verified: 2010-11

Locations

CN (1)