Early low-dose hydrocortisone in very preterm infants: a randomized, placebo-controlled trial.
BACKGROUND
Several reports indicate a decreased cortisol response to adrenocorticotropic hormone in preterm infants developing chronic lung disease and in preterm infants with refractory hypotension. Low-dose hydrocortisone (HC) may allow for beneficial effects.


OBJECTIVE
Our aim was to assess whether HC is able to increase survival without chronic lung disease.


METHODS
We performed a double-blind, randomized, placebo-controlled trial. Fifty mechanically ventilated infants (birth weight: 500-1,249 g) were randomized to receive treatment (HC 0.5 mg/kg/12 h for 9 days, then HC 0.5 mg/kg/24 h for 3 days) or placebo. Major outcome was survival without oxygen dependence at 36 weeks of postconceptional age (O(2)-free survival).


RESULTS
The basic characteristics were similar between the two groups. O(2)-free survival was higher in the HC group (64 vs. 32%). The advantage was particularly evident among infants without antenatal steroids. The mortality rate was 16% in the HC group versus 40% in the control group (difference not significant). Hypotension after recruitment was reduced by HC (0 vs. 30%). The incidence of gastrointestinal perforation and other adverse effects was similar between the two groups.


CONCLUSIONS
HC prophylaxis improved O(2)-free survival and early cardiocirculatory function in our population, without important short-term effects. The neurodevelopmental outcome will be assessed at 2 years.
Bonsante
F
F
Section of Neonatology and Neonatal Intensive Care Unit, Department of Pediatrics, University of Bari, Bari, Italy. fbonsante@libero.it
Latorre
G
G
Iacobelli
S
S
Forziati
V
V
Laforgia
N
N
Esposito
L
L
Mautone
A
A
D001794:Blood Pressure / Q000187:drug effects; D003907:Dexamethasone / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006854:Hydrocortisone / Q000627:therapeutic use*; D007231:Infant, Newborn; D007234:Infant, Premature; D019102:Infant, Very Low Birth Weight; D007363:Intensive Care Units, Neonatal; D008297:Male; D010919:Placebos; D017741:Survivors
D010919:Placebos; D003907:Dexamethasone; D006854:Hydrocortisone