Kumar Nair 2004.

Study characteristics
Methods	Single‐centre randomized controlled trial
Participants	Inclusion criteria Inborn infants with birth weight between 750 g and 1250 g, absence of major congenital anomalies, informed consent, absence of intraventricular haemorrhage prior to randomization Exclusion criteria Gestational age < 26 weeks Severely asphyxiated at birth (Apgar score < 5 at 5 minutes) Chromosomal aberrations Evidence of intrauterine or intrapartum sepsis on initial investigations Haematological or renal profiles contraindicating indomethacin administration
Interventions	Active intervention (n = 56) Indomethacin IV for a total of 3 doses at 0.1 mg/kg/dose. First dose administered over period of no less than 30 minutes between 6 and 12 hours of age, second and third dose administered at 24‐hour intervals if initial ultrasound detected no IVH. Control (n = 59) No placebo
Outcomes	Relevant outcomes for this study included Mortality IVH CLD NEC Surgical PDA ligation Periventricular leukomalacia
Notes	Primary study location: Royal Hospital, Oman Study period: March 1998 to March 2001 Trial registration: not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Simple random sampling method used for randomization.
Allocation concealment (selection bias)	Low risk	Sealed envelopes were used, mixed up, and stored in locked box.
Blinding of participants and personnel (performance bias) All outcomes	High risk	No evidence of blinding or placebo used for control
Blinding of outcome assessment (detection bias) All outcomes	High risk	No evidence of blinding or placebo used for control and no evidence of blinding of outcome assessors
Incomplete outcome data (attrition bias) All outcomes	Low risk	No incomplete outcome data were noted
Selective reporting (reporting bias)	Unclear risk	No protocol available for comparison
Other bias	Unclear risk	Study terminated prematurely.