None listed
Conditions
Interventions
Indomethacin (0.2mg loading dose intravenously followed by two doses of 0.1mg/kg at 24 hour intervals intravenously) given in first 12 hours of life in high risk premature infants with patent ductus arteriosus failing to constrict naturally as defined by an echocardiogram.
Sponsors
Martin Kluckow
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
3 Hours to 12 Hours
Healthy volunteers
No
Inclusion criteria
Infants born < 29 weeks gestational age Infants < 12 hours old Echocardiogram to assess ductal size able to be performed
Exclusion criteria
1] Intraventricular haemorrhage grade 3 – 4 at time of initial scan. 2] Baby is clinically unstable and not expected to survive. 3] Congenital anomalies predicted to influence neurodevelopmental outcome 4] Structural heart disease 5] R->L shunt - infants with near systemic or suprasystemic pulmonary pressure who may benefit from some RV pressure relief – R>L ductal flow for >33% of cardiac cycle. Rescan in same 12 hour time frame. 6] Contraindication to use of indomethacin or ibuprofen (Platelet count <50,000, Creatinine >120 micromol/L, use of NSAID antenatally) 7] Unlikely to be able to commence first dose of treatment by 12 hours of age 8] Consent not given
Outcome results
None listed