Preterm infants mechanical ventilation BPD Cortico steroids hydrocortisone
Conditions
Interventions
Administration of hydrocortisone or placebo during a 22 day tapering schedule.
Sponsors
Academisch Medisch Centrum Amsterdam
Eligibility
Inclusion criteria
Inclusion criteria: Preterm infants with: 1. A gestational age < 30 wks and/or birth weight < 1250 g; 2. Ventilator dependent at 7-14 days PNA; 3. A respiratory index (MAwP x FiO2) of ≥ 3.5 for more than 12 h/day for at least 48 hours, ensuring adequate oxygen saturation (85-95%) and pCO2 values in premature infants (5.0-7.5 kPa). Of note: These target are used to ensure comparable assessment of MAwP and FiO2. After inclusion of the patient in the study, physicians are free to use local targets for oxygenation and ventilation. During the first 6 months of the trial it became clear that the Respiratory Index (RI) was set to high. Ventilated extremely preterm infants at high risk for BPD were not included in the trial because the RI was < 3.5. These infants were treated with corticosteroids outside the trial. Based on this observation the RI was first lowered to 3.0 in may 2012. As this only partly solved corticosteroids treatment outside the trial, the RI was further lowered to 2.5 starting december 2012. Following this last RI change, the majority of infants at high risk for BPD were eligible for the STOP-BPD study. All changes were approved by the Ethics Committee.
Exclusion criteria
Exclusion criteria: 1. Chromosomal defects (e.g. trisomy 13, 18, 21); 2. Major congenital malformations that: A. Compromise lung function (e.g. surfactant protein deficiencies, congenital diaphragmatic hernia); B. Result in chronic ventilation (e.g. Pierre Robin sequence); C. Increase the risk of death or adverse neurodevelopmental outcome (congenital cerebral malformations). Of note: Intraventricular haemorrhages, periventricular leucomalacia and cerebral infarction are not considered congenital malformations and therefore are not exclusion criteria. 3. Use of dexamethasone or hydrocortisone for the sole purpose of improving lung function and respiratory status prior to inclusion.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Measure is survival free of BPD at 36 weeks postmenstrual age (PMA). | — |
Contacts
Public ContactDebbie Nuytemans
Dept. of Neonatology, Emma Children's Hospital AMC, PO Box 22660
Outcome results
None listed