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Clinical Trials/ACTRN12614000174684
ACTRN12614000174684
Completed
Phase 1

A pilot study evaluating the safety of intravenously administered human amnion epithelial cells for treatment of bronchopulmonary dysplasia (BPD) in premature babies

Monash Health Research Directorate0 sites6 target enrollmentFebruary 12, 2014
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Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Monash Health Research Directorate
Enrollment
6
Status
Completed
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 12, 2014
End Date
August 15, 2019
Last Updated
5 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Monash Health Research Directorate

Eligibility Criteria

Inclusion Criteria

  • •1\.Extreme prematurity (less than or equals to 28 weeks gestation at birth)
  • •2\.At least 36 weeks postmenstrual age
  • •3\.Ongoing requirement for respiratory support, inclusive of either intubated neonates and non\-invasive respiratory support (NIMV/ CPAP) with mean/ end pressure \>7 cm H2O
  • •4\.Stable, yet dependent on respiratory support in terms of oxygen requirement i.e. FiO2 between 0\.3 and 0\.5\.

Exclusion Criteria

  • •Infants who are mechanically ventilated with FiO2 requirement less than 0\.3 or more than 0\.5\.
  • •Infants with active infection (who are on intravenous antibiotics)
  • •Infants with intercurrent viral illness
  • •Infants with severe preterm brain injury (Grade III\-IV IVH, cystic PVL)
  • •Infants with active necrotizing enterocolitis (NEC)
  • •Infants receiving medical or surgical therapy for patent ductus arteriosus (PDA) at the time of enrolment

Outcomes

Primary Outcomes

Not specified

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