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Early low-dose hydrocortisone in very preterm infants: a randomized, placebo-controlled trial
F Bonsante1, G Latorre, S Iacobelli
1Section of Neonatology and Neonatal Intensive Care Unit, Department of Pediatrics, University of Bari, Bari, Italy. fbonsante@libero.it
Insights
Low-dose hydrocortisone (HC) improved survival without chronic lung disease in preterm infants. This treatment also reduced hypotension and showed no significant short-term adverse effects.
Area of Science:
- Neonatalogy
- Pediatric Pulmonology
- Endocrinology
Background:
- Preterm infants with chronic lung disease or hypotension show a decreased cortisol response.
- Low-dose hydrocortisone (HC) may offer therapeutic benefits in these vulnerable infants.
Purpose of the Study:
- To evaluate the efficacy of HC in increasing survival without chronic lung disease in preterm infants.
- To assess the impact of HC on early cardiocirculatory function and adverse effects.
Main Methods:
- A double-blind, randomized, placebo-controlled trial was conducted.
- Fifty mechanically ventilated preterm infants (500-1,249 g birth weight) received either HC or placebo.
- The primary outcome was survival without oxygen dependence at 36 weeks postconceptional age (O(2)-free survival).
Main Results:
- O(2)-free survival was significantly higher in the HC group (64% vs. 32%).
- HC reduced the incidence of hypotension and mortality (though not significantly).
- Adverse effects, including gastrointestinal perforation, were similar between groups.
Conclusions:
- Hydrocortisone prophylaxis enhances O(2)-free survival and early cardiocirculatory function in preterm infants.
- The treatment demonstrated a favorable short-term safety profile.
- Long-term neurodevelopmental outcomes are pending assessment at 2 years.
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.
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