BACKGROUND:Prophylactic indomethacin reduces the risk of severe intraventricular hemorrhage (IVH) but does not reduce death or neurodevelopmental impairment (NDI) among extremely low birth weight (ELBW) infants. Some investigators have suggested that prophylactic indomethacin may have a greater treatment effect on severe IVH among infants at high risk for severe IVH. OBJECTIVE: To determine whether the relative treatment effects of prophylactic indomethacin on severe IVH and the composite outcome of death or NDI vary based on the risk of severe IVH. METHODS: Post hoc analysis of the Trial of Indomethacin Prophylaxisin Preterms (TIPP). We generated a model to predict the risk for severe IVH based on gestational age, birth weight, antenatal steroids, delivery mode, outborn status, sex, and 5-min Apgar score, and we divided the TIPP participants into risk quartiles. We used logistic regression to determine the adjusted odds ratios (aOR) of severe IVH and death or NDI based on indomethacin treatment for each quartile. RESULTS: The relative treatment effects of prophylactic indomethacin on severe IVH did not vary based on the predicted risk of severe IVH: quartile 1: aOR 0.68 (95% confidence interval [CI] 0.19-2.37); quartile 2: aOR 0.61 (95% CI 0.27-1.42); quartile 3: aOR 0.63 (95% CI 0.31-1.31); quartile 4: aOR 0.58 (95% CI 0.32-1.05). The relative treatment effect of prophylactic indomethacin on death or NDI did not vary significantly between quartiles. CONCLUSIONS: These findings do not support selective prophylactic indomethacin treatment to improve long-term outcomes of ELBW infants at high risk for severe IVH.
RCT Entities:
BACKGROUND: Prophylactic indomethacin reduces the risk of severe intraventricular hemorrhage (IVH) but does not reduce death or neurodevelopmental impairment (NDI) among extremely low birth weight (ELBW) infants. Some investigators have suggested that prophylactic indomethacin may have a greater treatment effect on severe IVH among infants at high risk for severe IVH. OBJECTIVE: To determine whether the relative treatment effects of prophylactic indomethacin on severe IVH and the composite outcome of death or NDI vary based on the risk of severe IVH. METHODS: Post hoc analysis of the Trial of Indomethacin Prophylaxis in Preterms (TIPP). We generated a model to predict the risk for severe IVH based on gestational age, birth weight, antenatal steroids, delivery mode, outborn status, sex, and 5-min Apgar score, and we divided the TIPPparticipants into risk quartiles. We used logistic regression to determine the adjusted odds ratios (aOR) of severe IVH and death or NDI based on indomethacin treatment for each quartile. RESULTS: The relative treatment effects of prophylactic indomethacin on severe IVH did not vary based on the predicted risk of severe IVH: quartile 1: aOR 0.68 (95% confidence interval [CI] 0.19-2.37); quartile 2: aOR 0.61 (95% CI 0.27-1.42); quartile 3: aOR 0.63 (95% CI 0.31-1.31); quartile 4: aOR 0.58 (95% CI 0.32-1.05). The relative treatment effect of prophylactic indomethacin on death or NDI did not vary significantly between quartiles. CONCLUSIONS: These findings do not support selective prophylactic indomethacin treatment to improve long-term outcomes of ELBW infants at high risk for severe IVH.
Authors: B Schmidt; P Davis; D Moddemann; A Ohlsson; R S Roberts; S Saigal; A Solimano; M Vincer; L L Wright Journal: N Engl J Med Date: 2001-06-28 Impact factor: 91.245
Authors: Barbara Schmidt; Elizabeth V Asztalos; Robin S Roberts; Charlene M T Robertson; Reginald S Sauve; Michael F Whitfield Journal: JAMA Date: 2003-03-05 Impact factor: 56.272
Authors: Rachana Singh; Samuel V Gorstein; Frank Bednarek; Joseph H Chou; Elisabeth C McGowan; Paul F Visintainer Journal: Sci Rep Date: 2013 Impact factor: 4.379
Authors: Wafa Sattam M Alotaibi; Nada S Alsaif; Ibrahim A Ahmed; Aly Farouk Mahmoud; Kamal Ali; Abdullah Hammad; Omar S Aldibasi; Saif A Alsaif Journal: Childs Nerv Syst Date: 2020-05-04 Impact factor: 1.475
Authors: Carl H Backes; Kevin D Hill; Elaine L Shelton; Jonathan L Slaughter; Tamorah R Lewis; Dany E Weisz; May Ling Mah; Shazia Bhombal; Charles V Smith; Patrick J McNamara; William E Benitz; Vidu Garg Journal: J Am Heart Assoc Date: 2022-09-03 Impact factor: 6.106