Abstract
Objective: We conducted a multicenter, randomized, controlled trial to determine whether higher doses of indomethacin would improve the rate of patent ductus arteriosus (PDA) closure. Study design: Infants (<28 weeks gestation) who received a conventional, prophylactic 3-dose course of indomethacin were eligible if they had continued evidence of persistent ductus patency on an echocardiogram obtained before the third prophylactic indomethacin dose. Infants (n = 105) were randomized to receive an extended 3-day course of either low-dose (0.1 mg/kg/d) or higher-dose (0.2 or 0.5 mg/kg/d) indomethacin. An echocardiogram was obtained 24 hours after the last dose of study drug. Results: Despite increasing serum indomethacin concentrations by 2.9-fold in the higher-dose group, we failed to detect a significant decrease in the rate of persistent PDA (low = 52%; higher = 45%, P = .50). The higher-dose group had a significantly higher occurrence of serum creatinine >2 mg/100 mL (low = 6%, higher = 19%, P < .05) and moderate/severe retinopathy of prematurity (ROP) (low = 15%, higher = 36%, P < .025). The incidence of moderate/severe ROP was directly related to the poststudy indomethacin concentrations (odds ratio = 1.75, confidence interval: 1.15-2.68, P < .01). Conclusion: Increasing indomethacin concentrations above the levels achieved with a conventional dosing regimen had little effect on the rate of PDA closure but was associated with higher rates of moderate/severe ROP and renal compromise.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 183-189 |
| Number of pages | 7 |
| Journal | Journal of Pediatrics |
| Volume | 153 |
| Issue number | 2 |
| DOIs | |
| State | Published - Aug 2008 |
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ASJC Scopus subject areas
- Pediatrics, Perinatology, and Child Health
Cite this
Increased Indomethacin Dosing for Persistent Patent Ductus Arteriosus in Preterm Infants : A Multicenter, Randomized, Controlled Trial. / Jegatheesan, Priya; Ianus, Vlad; Buchh, Basharat; Yoon, Grace; Chorne, Nancy; Ewig, Audrey; Lin, Emil; Fields, Scott; Moon-Grady, Anita; Tacy, Terri; Milstein, Jay M; Schreiber, Michael; Padbury, James; Clyman, Ronald.
In: Journal of Pediatrics, Vol. 153, No. 2, 08.2008, p. 183-189.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Increased Indomethacin Dosing for Persistent Patent Ductus Arteriosus in Preterm Infants
T2 - A Multicenter, Randomized, Controlled Trial
AU - Jegatheesan, Priya
AU - Ianus, Vlad
AU - Buchh, Basharat
AU - Yoon, Grace
AU - Chorne, Nancy
AU - Ewig, Audrey
AU - Lin, Emil
AU - Fields, Scott
AU - Moon-Grady, Anita
AU - Tacy, Terri
AU - Milstein, Jay M
AU - Schreiber, Michael
AU - Padbury, James
AU - Clyman, Ronald
PY - 2008/8
Y1 - 2008/8
N2 - Objective: We conducted a multicenter, randomized, controlled trial to determine whether higher doses of indomethacin would improve the rate of patent ductus arteriosus (PDA) closure. Study design: Infants (<28 weeks gestation) who received a conventional, prophylactic 3-dose course of indomethacin were eligible if they had continued evidence of persistent ductus patency on an echocardiogram obtained before the third prophylactic indomethacin dose. Infants (n = 105) were randomized to receive an extended 3-day course of either low-dose (0.1 mg/kg/d) or higher-dose (0.2 or 0.5 mg/kg/d) indomethacin. An echocardiogram was obtained 24 hours after the last dose of study drug. Results: Despite increasing serum indomethacin concentrations by 2.9-fold in the higher-dose group, we failed to detect a significant decrease in the rate of persistent PDA (low = 52%; higher = 45%, P = .50). The higher-dose group had a significantly higher occurrence of serum creatinine >2 mg/100 mL (low = 6%, higher = 19%, P < .05) and moderate/severe retinopathy of prematurity (ROP) (low = 15%, higher = 36%, P < .025). The incidence of moderate/severe ROP was directly related to the poststudy indomethacin concentrations (odds ratio = 1.75, confidence interval: 1.15-2.68, P < .01). Conclusion: Increasing indomethacin concentrations above the levels achieved with a conventional dosing regimen had little effect on the rate of PDA closure but was associated with higher rates of moderate/severe ROP and renal compromise.
AB - Objective: We conducted a multicenter, randomized, controlled trial to determine whether higher doses of indomethacin would improve the rate of patent ductus arteriosus (PDA) closure. Study design: Infants (<28 weeks gestation) who received a conventional, prophylactic 3-dose course of indomethacin were eligible if they had continued evidence of persistent ductus patency on an echocardiogram obtained before the third prophylactic indomethacin dose. Infants (n = 105) were randomized to receive an extended 3-day course of either low-dose (0.1 mg/kg/d) or higher-dose (0.2 or 0.5 mg/kg/d) indomethacin. An echocardiogram was obtained 24 hours after the last dose of study drug. Results: Despite increasing serum indomethacin concentrations by 2.9-fold in the higher-dose group, we failed to detect a significant decrease in the rate of persistent PDA (low = 52%; higher = 45%, P = .50). The higher-dose group had a significantly higher occurrence of serum creatinine >2 mg/100 mL (low = 6%, higher = 19%, P < .05) and moderate/severe retinopathy of prematurity (ROP) (low = 15%, higher = 36%, P < .025). The incidence of moderate/severe ROP was directly related to the poststudy indomethacin concentrations (odds ratio = 1.75, confidence interval: 1.15-2.68, P < .01). Conclusion: Increasing indomethacin concentrations above the levels achieved with a conventional dosing regimen had little effect on the rate of PDA closure but was associated with higher rates of moderate/severe ROP and renal compromise.
UR - http://www.scopus.com/inward/record.url?scp=47049124038&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=47049124038&partnerID=8YFLogxK
U2 - 10.1016/j.jpeds.2008.01.031
DO - 10.1016/j.jpeds.2008.01.031
M3 - Article
C2 - 18534218
AN - SCOPUS:47049124038
VL - 153
SP - 183
EP - 189
JO - Journal of Pediatrics
JF - Journal of Pediatrics
SN - 0022-3476
IS - 2
ER -