OBJECTIVE: To study the efficacy and complications of low dose indomethacin in the reduction of major intraventricular hemorrhage (IVH) in very low birth weight (VLBW) babies. DESIGN: prospective randomized controlled trial (interim analysis) SETTING: Level III neonatal intensive care unit of a perinatal tertiary care center. PATIENTS: Newborn babies with birth weights between 750-1250 g were randomized into indomethacin or control groups. They were further stratified into two birth weight groups 750-999 g and 1000-1250 g for subgroup analysis. INTERVENTIONS: 3 doses of indomethacin were administered to the indomethacin group at the dose of 0.1 mg/kg/dose intravenously. The control group did not receive any specific intervention other than standard neonatal intensive care. OUTCOME MEASURES: The primary outcome measure was the occurrence of IVH and the secondary outcome measures were necrotising enterocolitis, symptomatic patent ductus arteriosus (PDA), bleeding episodes, renal failure, chronic-lung disease and death. RESULTS: Out of 115 eligible newborn babies, 56 babies receivedindomethacin and 59 were controls. Perinatal characteristics were similar between the two groups. There was no difference in the incidence of IVH between the groups but on subgroup analysis the incidence of major IVH (grades III and IV) were significantly increased in babies in the lower birth weight category who received indomethacin P = 0.03). The incidence of chronic lung disease was significantly higher in the indomethacin group (P = 0.005) and bleeding episodes other than IVH were also significantly increased in the indomethacin group (P = 0.04) in the lower birth weight category. The incidence of PDA was lower in the indomethacin group but only reached significant level in the higher birth weight subgroup (P = 0.02). There were no significant differences in the other outcome measures studied. CONCLUSIONS:Indomethacin prophylaxis did not confer protection against IVH in very low birth weight babies. Instead it showed an increase in the risk of IVH, other bleeding episodes and chronic lung disease. Based on this data we felt that we were not ethically justified in continuing the use of indomethacin and have since terminated this study.
RCT Entities:
OBJECTIVE: To study the efficacy and complications of low dose indomethacin in the reduction of major intraventricular hemorrhage (IVH) in very low birth weight (VLBW) babies. DESIGN: prospective randomized controlled trial (interim analysis) SETTING: Level III neonatal intensive care unit of a perinatal tertiary care center. PATIENTS: Newborn babies with birth weights between 750-1250 g were randomized into indomethacin or control groups. They were further stratified into two birth weight groups 750-999 g and 1000-1250 g for subgroup analysis. INTERVENTIONS: 3 doses of indomethacin were administered to the indomethacin group at the dose of 0.1 mg/kg/dose intravenously. The control group did not receive any specific intervention other than standard neonatal intensive care. OUTCOME MEASURES: The primary outcome measure was the occurrence of IVH and the secondary outcome measures were necrotising enterocolitis, symptomatic patent ductus arteriosus (PDA), bleeding episodes, renal failure, chronic-lung disease and death. RESULTS: Out of 115 eligible newborn babies, 56 babies received indomethacin and 59 were controls. Perinatal characteristics were similar between the two groups. There was no difference in the incidence of IVH between the groups but on subgroup analysis the incidence of major IVH (grades III and IV) were significantly increased in babies in the lower birth weight category who received indomethacin P = 0.03). The incidence of chronic lung disease was significantly higher in the indomethacin group (P = 0.005) and bleeding episodes other than IVH were also significantly increased in the indomethacin group (P = 0.04) in the lower birth weight category. The incidence of PDA was lower in the indomethacin group but only reached significant level in the higher birth weight subgroup (P = 0.02). There were no significant differences in the other outcome measures studied. CONCLUSIONS:Indomethacin prophylaxis did not confer protection against IVH in very low birth weight babies. Instead it showed an increase in the risk of IVH, other bleeding episodes and chronic lung disease. Based on this data we felt that we were not ethically justified in continuing the use of indomethacin and have since terminated this study.
Authors: Souvik Mitra; Courtney E Gardner; Abigale MacLellan; Tim Disher; Danielle M Styranko; Marsha Campbell-Yeo; Stefan Kuhle; Bradley C Johnston; Jon Dorling Journal: Cochrane Database Syst Rev Date: 2022-04-01
Authors: Tim Hundscheid; Esther J S Jansen; Wes Onland; Elisabeth M W Kooi; Peter Andriessen; Willem P de Boode Journal: Front Pediatr Date: 2021-02-25 Impact factor: 3.418