bronchopulmonary dysplasia MedDRA version: 12.1 Level: LLT Classification code 10006475 Term: Bronchopulmonary dysplasia
Conditions
Interventions
Trade Name: hydrocortisone
Product Name: hydrocortisone
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Hydrocortisone
CAS Number: 50-23-7
Current Sponsor code: N/A
Other d
Sponsors
Academic Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Preterm infants with a gestational age =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Infants with chromosomal defects (e.g. trisomy 13, 18, 21) or major congenital malformations that are expected to compromise lung function (e.g. surfactant protein deficiencies, congenital diaphragmatic hernia) or result in chronic ventilation (e.g. Pierre Robin sequence), or increase the risk of death or adverse neurodevelopmental outcome (congenital cerebral malformations) will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish the efficacy of hydrocortisone given after one week of life to reduce the incidence of the combined outcome death or BPD in chronically ventilated preterm infants.;Secondary Objective: Secondary outcomes are short term effects on the pulmonary condition, adverse effects during hospitalization, and long-term neurodevelopmental sequelae assessed at 2 years corrected gestational age (CGA).;Primary end point(s): the dichotomous variable BPD free survival at 36 weeks PMA. BPD at 36 weeks PMA will be assessed according to the NIHCHD Consensus Statement defining normal oxygen saturation as 86%-94%. The severity of the BPD will be assessed as proposed by Jobe et.al., since the severity of BPD has a high association with neurodevelopmental sequelae. In case of supplemental oxygen delivery >21% and < 30% or low flow at 36 weeks PMA, the oxygen reduction test as described by Walsh et.al. should be preformed. A positive oxygen reduction test has a high correlation with the risk on discharge home with oxygen, the length of hospital stay, and pulmonary morbidity requiring hospital readmission during the first year of life. | — |
Countries
Belgium, Netherlands
Outcome results
None listed