- 199 premature
infants with at least some oxygen requirement and weighing less than
or equal to 1300 gms. were randomized to receive either IV indomethacin
or placebo. Exclusion criteria included terminal conditions, prestudy
Grade 2-4 IVH, major congenital malformations or infection, and hemostatic
- Patients had
a cranial ultrasound prior to randomization, daily for the first three
days, weekly for the first two weeks, and then at least every two weeks
until there was resolution or stabilization of the bleed. The
radiologist was blinded to the patient's study assignment.
- 46% of the placebo
arm had final IVH grade between 2-4 as compared to only 23% in the indomethacin
group (P<.02). The impact was most pronounced for Grade 2 IVH
but the indomethacin group did also have fewer Grade 3-4 hemorrhages
(in terms of absolute numbers).
- The reduction
in risk for Grade 2-4 IVH was seen in both the 500-899 gms. and the
900-1300 gms. groups (P<.05).
- 10 out of 14
of the placebo group who started with Grade 1 IVH subsequently extended
to Grade 2-4. 6 out of 14 of the indomethacin group extended.
- Oliguria (defined
as urine output <1ml/kg/hr) was noted in 40 of the indomethacin treated
patients compared with 20 placebo treated patients (P,.001). 15%
of the indomethacin group weighing 900-1300 had ROP >or =to stage
3 as opposed to 3% of the placebo group (P<.07).