Bronchopulmonary dysplasia MedDRA version: 14.0 Level: PT Classification code 10006475 Term: Bronchopulmonary dysplasia System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: Solu-Cortef
Product Name: hydrocortisone
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Solu-Cortef
CAS Number: 50-23-7
Current Sponsor code: N/A
Other descrip
Sponsors
UZ Brussel
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 compromise lung function (e.g. surfactant protein deficiencies, congenital diaphragmatic hernia), 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. Also infants who received dexamethasone or hydrocortisone for the sole purpose of improving lung function and respiratory status prior to inclusion, 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 of death and bronchopulmonary dysplasia in chronically ventilated preterm infants.;Secondary Objective: Secondary outcomes are short term effects on the pulmonary condition, adverse effects during hospitalisation, and long-term neurodevelopmental sequelae assessed at 2 years corrected gestational age.;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.21, since the severity of BPD has a high association with neurodevelopmental sequelae.12 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.21,49,50 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.;Timepoint(s) of evaluation of this end point: 36 weeks postmenstrual age | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • treatment failure as defined in section 6.1.2 • mortality at 28 days PNA, 36 weeks PMA and at hospital discharge • BPD at 28 days • failure to extubate 3, 7, 14 and 21 days after initiating therapy • duration of mechanical ventilation • use of “rescue treatment” with hydrocortisone outside the study protocol • total time on supplemental oxygen • length of hospital stay • incidence of hypertension, defined as systolic blood pressure > 2SD of standardized values used in the department • hyperglycemia requiring the use of insulin therapy • nosocomial infection, like sepsis, meningitis and pneumonia • hemodynamic significant patent ductus arteriosus for which medical intervention or surgical ligation is needed • necrotising enterocolitis (NEC), diagnosed at surgery, autopsy or by radiographic finding of pneumotosis intestinalis or hepatobiliary gas (Bell stage II) • gastrointestinal bleeding • isolated gastrointestinal perforation diagnosed on abdominal radiography • intraventricular haemorrhage (IVH) and/or periventricular leucomalacia (PVL), including grading on cerebral ultrasonography according to protocol defined by Ment et.al.51 • retinopathy of prematurity, including grading following international classification52 • weight gain, head circumference and length gain at 36 weeks PMA • long-term health and neurodevelopmental sequelae, assessed at 2 years CGA: o readmissions since first discharge home o weight, length and head circumference at 24 months c.a. o Bayley Scales of Infant Development III, Mental Developmental Index and Psychomotor Developmental Index o cerebral palsy and severity of cerebral palsy using gross motor function classification system o hearing loss requiring hearing aids o blindness ;Timepoint(s) of evaluation of this end point: - End of hospitalisation - neurodevelopment will be assessed at 2 years corrected age | — |
Countries
Belgium, Netherlands
Contacts
Public ContactAnton van Kaam
Academic Medical Center Amsterdam
Outcome results
None listed