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Prolonged low dose indomethacin for persistent ductus arteriosus of prematurity
1Department of Paediatrics, Addenbrooke's Hospital, Cambridge.
Insights
A prolonged, low-dose indomethacin regimen for persistent ductus arteriosus in infants showed higher initial response rates and fewer relapses compared to conventional treatment. This approach also reduced kidney function changes.
Area of Science:
- Neonatalogy
- Pediatric Pharmacology
- Cardiology
Background:
- Persistent ductus arteriosus (PDA) is a common condition in premature infants.
- Indomethacin is a standard treatment for PDA, but optimal dosing regimens are debated.
- Variations in treatment protocols may affect efficacy and safety.
Purpose of the Study:
- To compare the efficacy and safety of a prolonged, low-dose indomethacin regimen versus a conventional short-course regimen for PDA in infants.
- To evaluate initial response rates, relapse rates, and adverse effects, including renal function changes.
Main Methods:
- Randomized trial involving 121 infants requiring indomethacin for PDA.
- Two treatment arms: prolonged low-dose (0.1 mg/kg daily for 6 days) vs. conventional short-dose (0.2 mg/kg every 12 hours for 3 doses).
- Data collected on initial response, relapses, gastrointestinal hemorrhage, and serum creatinine/urea levels.
Main Results:
- Higher initial response rate in the prolonged low-dose group (90%) compared to the conventional group (77%).
- Significantly lower relapse rate in the prolonged low-dose group (21%) versus the conventional group (40%).
- Fewer infants in the prolonged low-dose group experienced elevations in serum creatinine or urea.
Conclusions:
- A prolonged, low-dose indomethacin course demonstrates superior efficacy in achieving initial closure and preventing relapses of PDA.
- This regimen appears to be safer regarding renal function compared to conventional short-course therapy.
- Optimized indomethacin dosing strategies can improve PDA management in neonates.
Abstract:
A total of 121 infants who required indomethacin for persistent ductus arteriosus in Liverpool and Cambridge over a four year period were randomised to receive either 0.1 mg/kg daily for six days or 0.2 mg/kg every 12 hours for three doses. The groups were of similar birth weight and gestational and postnatal age, though those treated with a low dose were by chance receiving a higher percentage of oxygen at the start of treatment and there were more deaths from bronchopulmonary dysplasia in this group. Of 59 infants treated with the prolonged course 53 (90%) responded initially to indomethacin compared with 48 of 62 (77%) treated conventionally--a difference of 13% (95% confidence interval for the difference 0 to 26%). Of the 53 responders 11 (21%) relapsed after low dose indomethacin, whereas after the shorter course 19 of 48 (40%) relapsed. This difference was significant (95% confidence intervals 3 to 37%). Side effects, mainly gastrointestinal haemorrhage, were similar in both groups. Significantly fewer infants experienced a rise in serum creatinine or urea concentration after treatment with low dose indomethacin. A prolonged low dose course of indomethacin offers advantages over conventional treatment.