Randomised equivalency trial comparing 2.5% povidone-iodine eye drops and ophthalmic chloramphenicol for preventing neonatal conjunctivitis in a trachoma endemic area in southern Mexico.
OBJECTIVE
To evaluate the effectiveness of 2.5% povidone-iodine eye drops (PIED) compared with ophthalmic chloramphenicol (OC) for preventing neonatal conjunctivitis.


METHODS
2004 neonates were enrolled from three rural hospitals in a trachoma endemic area. They were randomly assigned to receive either PIED (n = 1024) or OC (n = 974). Infectious conjunctivitis was confirmed by laboratory methods, including specific search for Chlamydia trachomatis by polymerase chain reaction assay.


RESULTS
During the first 48 hours after birth, PIED and OC had similar efficacy against bacterial conjunctivitis (95% confidence interval (CI), -0.031 to -0.004; p = 0.01); from day 3 to day 15, PIED was 6% less effective than OC (95% CI, -0.058 to -0.006; p = 0.01); after day 16 there was no significant difference between the groups (95% CI, -0.022 to 0.041; p = 0.57). However, the risk of C trachomatis conjunctivitis was increased in neonates receiving PIED prophylaxis (relative risk = 1.99 (95% CI, 1.07 to 3.71), log-rank p = 0.029). Ocular side effects were rare and self limiting in both groups (p = 0.223).


CONCLUSIONS
PIED seems to increase the risk of acquiring chlamydial conjunctivitis in neonates. Additional measures are required to prevent mother to fetus transmission of chlamydial infection during pregnancy, delivery, and after birth.
Ramirez-Ortiz
Marco A
MA
Department of Ophthalmology, Hospital Infantil de México Federico Gómez, Calle Doctor Marquez 162, Colonia Doctores, CP 06720, Mexico City, Mexico. marco@servidor.unam.mx
Rodriguez-Almaraz
Manuel
M
Ochoa-Diazlopez
Héctor
H
Diaz-Prieto
Paulina
P
Rodriguez-Suárez
Romeo S
RS
D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D000891:Anti-Infective Agents, Local / Q000009:adverse effects / Q000627:therapeutic use*; D002692:Chlamydia trachomatis / Q000302:isolation & purification; D002701:Chloramphenicol / Q000627:therapeutic use; D003234:Conjunctivitis, Bacterial / Q000382:microbiology / Q000517:prevention & control / Q000635:transmission; D019353:Endemic Diseases; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D008297:Male; D008800:Mexico / Q000453:epidemiology; D009883:Ophthalmic Solutions; D011206:Povidone-Iodine / Q000009:adverse effects / Q000627:therapeutic use*; D014141:Trachoma / Q000453:epidemiology / Q000517:prevention & control* / Q000635:transmission; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D000891:Anti-Infective Agents, Local; D009883:Ophthalmic Solutions; D002701:Chloramphenicol; D011206:Povidone-Iodine