To determine if mesenchymal stem cells, administered intravenously or endotracheally, are safe and effective in preventing and/or treating bronchopulmonary dysplasia in preterm infants.
We will perform the following specific comparisons.
- Prevention:to determine if mesenchymal stem cells administered intravenously or endotracheally within the first week of life are able to prevent bronchopulmonary dysplasia in extremely preterm infants < 26 weeks gestation.
- Treatment of evolving bronchopulmonary dysplasia: to determine if mesenchymal stem cells administered intravenously or endotracheally at > one week of age but less than 36 weeks postmenstrual age are able to prevent bronchopulmonary dysplasia in preterm infants on supplemental oxygen or respiratory support.
- Treatment of established bronchopulmonary dysplasia: to determine if mesenchymal stem cells administered intravenously or endotracheally at ≥ 36 weeks postmenstrual age are able to reduce mortality in preterm infants on respiratory support and/or supplemental oxygen > 30%.
We will also conduct subgroup analyses including gestational age, source of stem cells, type of graft, route of administration, mesenchymal stem cell dose, number of doses, passages, disease severity at time of study entry, and exposure to postnatal steroids (Subgroup analysis and investigation of heterogeneity).
This is a protocol.