Allogeneic human umbilical cord-derived mesenchymal stem cells for severe bronchopulmonary dysplasia in children: study protocol for a randomized controlled trial (MSC-BPD trial)

Table 3 Outcome measures

Measures			Time frames
Primary outcomes	Cumulative duration of oxygen therapy		Until the time of stopping oxygen therapy
Secondary outcomes	Adverse events	Number of serious adverse events	Within 24 h post hUC-MSCs infusion
		Acute infusion associated adverse events	From the start of the trials to 1 month post hUC-MSCs infusion
		Late infusion associated adverse events	Within 2 years post hUC-MSCs infusion
	The rate of supplemental oxygen therapy		At 1 month post hUC-MSCs infusion
	Duration of invasive mechanical ventilation
	Duration of noninvasive mechanical ventilation
	The first time of stopping oxygen supplement
	The rate of re-oxygen supplement
	Pulmonary function changes		At 6, 12, and 24 months post hUC-MSCs infusion
	Chest radiography changes		At 6, 12, and 24 months post hUC-MSCs infusion
	Blood oxygen saturation		At 1, 3, 6, 12, and 24 months post hUC-MSCs infusion
	Mortality
	Times of hospital readmissions
	Complications of preterm birth

ISSN: 1745-6215