CClinicalTrials.gg
Status unknownNCT01265589RDSUpdated Jul 26, 2011

Intratracheal Vitamin A Administration With Surfactant for Newborn Respiratory Distress Syndrome

A Phase 3 interventional study of surfactant and surfactant+vitamin A in RDS, Infant, Newborn and Vitamin A, sponsored by Third Military Medical University. Status unknown at 1 site in China. Open to participants aged Up to 28 Days. Per ClinicalTrials.gov, last updated 2011-07-26.

Sponsored by Third Military Medical University · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2010), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
Up to 28 Days
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • RDS
  • Infant, Newborn
  • Vitamin A
  • Surfactant

Keywords

  • RDS
  • Infant, newborn
  • Vitamin A
  • Surfactant
03

In context

Respiratory Distress Syndrome

1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.

This study's planned enrollment of 100 is above the median of 60 across 961 interventional studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

Third Military Medical University is the lead sponsor of 81 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 28 Days
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Placebo comparator
    I=surfactant

    Intratracheal Surfactant Administration without Vitamin A for Newborn Respiratory Distress Syndrome

    Drug: surfactant

  • Experimental
    II=surfactant+vitamin A

    Intratracheal Surfactant Administration with Vitamin A for Newborn Respiratory Distress Syndrome

    Drug: surfactant+vitamin A

Interventions

  • Drugsurfactant

    Intratracheal Surfactant Administration without Vitamin A for Newborn Respiratory Distress Syndrome

  • Drugsurfactant+vitamin A

    Intratracheal Surfactant Administration with Vitamin A for Newborn Respiratory Distress Syndrome

06

What researchers measure

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

    Time frame: 1 year

Secondary outcomes

  1. Overall clinical outcomes at Newborn Infants With Respiratory Distress Syndrome

    analysis the date and drow a conclusion

    Time frame: 13 months

07

Study locations

1 site
  • Deaprtment of Pediatrics, Daping Hospital, Third Military Medical University
    Chongqing, Chongqing 400042, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 26, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01265589
Lead sponsor
Third Military Medical University
First posted
Dec 23, 2010
Start date
Jan 2012
Primary completion
Dec 2012 (estimated)
Completion
Dec 2013 (estimated)
Last update
Jul 26, 2011

Study contacts

Heqiang Sun
Contact
sunheqiang1@sina.com
+86 15310303739
Yuan Shi, MD
Contact
petshi530@vip.163.com
+86 23 68757731
Yuan Shi, MD
study director · Department of Pediatrics, Daping Hospital, Third Military Medical University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2010. You cannot join it, but the record below documents what was studied.

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