Ibuprofen for the prevention of patent ductus arteriosus in preterm and/or low birth weight infants

Abstract

Prophylactic use of ibuprofen decreased the incidence of PDA, decreased the need for rescue treatment with cyclo-oxygenase inhibitors and decreased the need for surgical closure. In the control group, the PDA closed spontaneously by day three in 58% of the neonates. Prophylactic treatment exposes many infants to a drug that has concerning renal and gastrointestinal side effects without conferring any important short-term benefits and is not recommended. Until long-term follow-up results are published from the trials included in this updated review, no further trials of prophylactic ibuprofen are recommended.

Prophylactic Indomethacin Compared with Delayed Conservative Management of the Patent Ductus Arteriosus in Extremely Preterm Infants: Effects on Neonatal Outcomes

“…In our Final Adjusted models, we found no significant differences between the two treatment approaches in the incidences of either death, grades 3 or 4 IVH, intestinal perforation or NEC occurring either before 10 days or at any time during the hospitalization, or the use of laser or bevacizumab treatment for ROP (Table III). This is consistent with the results of the previously published RCTs (2, 4, 6–9). …”

Prophylactic Indomethacin Compared with Delayed Conservative Management of the Patent Ductus Arteriosus in Extremely Preterm Infants: Effects on Neonatal Outcomes

“…In our Final Adjusted models, we found no significant differences between the two treatment approaches in the incidences of either death, grades 3 or 4 IVH, intestinal perforation or NEC occurring either before 10 days or at any time during the hospitalization, or the use of laser or bevacizumab treatment for ROP (Table III). This is consistent with the results of the previously published RCTs (2, 4, 6–9). …”

Intraventricular Hemorrhage: Risk Factors and Association With Patent Ductus Arteriosus Treatment in Extremely Preterm Neonates

“…Our findings are consistent with the 2010 and 2011 Cochrane reviews, which showed that the use of early indomethacin was associated with a decreased severity of IVH, and that early ibuprofen did not cause a statistically significant reduction in IVH (24, 25). However, with early indomethacin, we did not see a reduction in the overall incidence of IVH (only severe IVH).…”

PDA-TOLERATE Trial: An Exploratory Randomized Controlled Trial of Treatment of Moderate-to-Large Patent Ductus Arteriosus at 1 Week of Age

“…Early treatment was associated with delayed time to achieve enteral feeding of 120 mL/kg/day, increased incidence of late-onset bacteremia (with organisms other than coagulase-negative Staphylococcus ), and increased incidence of death among infants of ≥26 weeks gestational age at birth (Table VI). The increased incidences of late-onset bacteremia and death in our ERT group were not been observed in previous RCTs 8,17,19–21,23 and thus may be due to chance. However, there are important differences in study design between our trial and previous RCTs that may account for the apparent differences in infection and death rates between our ERT and CT groups.…”

Prophylactic Indomethacin Compared with Delayed Conservative Management of the Patent Ductus Arteriosus in Extremely Preterm Infants: Effects on Neonatal Outcomes

“…In our Final Adjusted models, we found no significant differences between the two treatment approaches in the incidences of either death, grades 3 or 4 IVH, intestinal perforation or NEC occurring either before 10 days or at any time during the hospitalization, or the use of laser or bevacizumab treatment for ROP (Table III). This is consistent with the results of the previously published RCTs (2, 4, 6–9). …”

Intraventricular Hemorrhage: Risk Factors and Association With Patent Ductus Arteriosus Treatment in Extremely Preterm Neonates

“…Our findings are consistent with the 2010 and 2011 Cochrane reviews, which showed that the use of early indomethacin was associated with a decreased severity of IVH, and that early ibuprofen did not cause a statistically significant reduction in IVH (24, 25). However, with early indomethacin, we did not see a reduction in the overall incidence of IVH (only severe IVH).…”

PDA-TOLERATE Trial: An Exploratory Randomized Controlled Trial of Treatment of Moderate-to-Large Patent Ductus Arteriosus at 1 Week of Age

“…Early treatment was associated with delayed time to achieve enteral feeding of 120 mL/kg/day, increased incidence of late-onset bacteremia (with organisms other than coagulase-negative Staphylococcus ), and increased incidence of death among infants of ≥26 weeks gestational age at birth (Table VI). The increased incidences of late-onset bacteremia and death in our ERT group were not been observed in previous RCTs 8,17,19–21,23 and thus may be due to chance. However, there are important differences in study design between our trial and previous RCTs that may account for the apparent differences in infection and death rates between our ERT and CT groups.…”

Prophylactic Indomethacin Compared with Delayed Conservative Management of the Patent Ductus Arteriosus in Extremely Preterm Infants: Effects on Neonatal Outcomes

“…In our Final Adjusted models, we found no significant differences between the two treatment approaches in the incidences of either death, grades 3 or 4 IVH, intestinal perforation or NEC occurring either before 10 days or at any time during the hospitalization, or the use of laser or bevacizumab treatment for ROP (Table III). This is consistent with the results of the previously published RCTs (2, 4, 6–9). …”

Intraventricular Hemorrhage: Risk Factors and Association With Patent Ductus Arteriosus Treatment in Extremely Preterm Neonates

“…Our findings are consistent with the 2010 and 2011 Cochrane reviews, which showed that the use of early indomethacin was associated with a decreased severity of IVH, and that early ibuprofen did not cause a statistically significant reduction in IVH (24, 25). However, with early indomethacin, we did not see a reduction in the overall incidence of IVH (only severe IVH).…”

PDA-TOLERATE Trial: An Exploratory Randomized Controlled Trial of Treatment of Moderate-to-Large Patent Ductus Arteriosus at 1 Week of Age

“…Early treatment was associated with delayed time to achieve enteral feeding of 120 mL/kg/day, increased incidence of late-onset bacteremia (with organisms other than coagulase-negative Staphylococcus ), and increased incidence of death among infants of ≥26 weeks gestational age at birth (Table VI). The increased incidences of late-onset bacteremia and death in our ERT group were not been observed in previous RCTs 8,17,19–21,23 and thus may be due to chance. However, there are important differences in study design between our trial and previous RCTs that may account for the apparent differences in infection and death rates between our ERT and CT groups.…”