Amnion cells for the treatment of bronchopulmonary dysplasia in premature babies

Phase 1

Completed

• Conditions: Bronchopulmonary dysplasia; Respiratory - Other respiratory disorders / diseases; Reproductive Health and Childbirth - Complications of newborn

• Registration Number: ACTRN12614000174684
• Lead Sponsor: Monash Health Research Directorate

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-02-12
• Study Completion: 2019-08-15
• Last Update Posted: 16 February 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified