[Serious adverse side effects after pupillary dilation in preterm infants].
OBJECTIVE
This study aimed at investigating serious side effects of the pupillary dilation protocol used in Caen University Hospital for the screening of retinopathy of prematurity. This protocol includes one drop of phenylephrine 5% and two drops of tropicamide 0.5% instilled at a 5-minute interval.


METHODS
This retrospective study included all premature infants with a birth weight less than or equal to 1500 g and/or a gestational age less than or equal to 30 gestational weeks, hospitalized in the neonatal intensive care unit of Caen University Medical Center, having ocular fundus examinations for retinopathy of prematurity screening between 2009 and 2014. The medical records of patients who died or developed necrotizing enterocolitis were reviewed to analyze the imputability of the two eye drops used for pupil dilation.


RESULTS
Five-hundred and twelve infants were included, corresponding to 1033 ocular fundus examinations. No case of death could be ascribed to the use of eye drops. Two cases of necrotizing enterocolitis could be ascribed to the use of tropicamide with a doubtful and plausible intrinsic imputability according to French imputability criteria.


CONCLUSIONS
The pupillary dilation protocol used in Caen University Hospital for screening of retinopathy of prematurity might be implicated in two cases of necrotizing enterocolitis with an uncertain imputability of tropicamide 0.5% eye drops. No serious side effect could be ascribed to the use of phenylephrine 5% eye drops in this study.
CHU de Caen, avenue de la Côte-de-Nacre, 14000 Caen cedex, France. Electronic address: lux-al@chu-caen.fr.
A-L
AL
Lux
CHU Pontchaillou de Rennes, rue Henri-Le-Guilloux, 35000 Rennes, France.
F
F
Mouriaux
CHU de Caen, avenue de la Côte-de-Nacre, 14000 Caen cedex, France.
B
B
Guillois
CHU de Caen, avenue de la Côte-de-Nacre, 14000 Caen cedex, France.
S
S
Fedrizzi
CHU de Caen, avenue de la Côte-de-Nacre, 14000 Caen cedex, France.
L
L
Peyro-Saint-Paul
CHU de Caen, avenue de la Côte-de-Nacre, 14000 Caen cedex, France.
E
E
Denion
D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D020345:Enterocolitis, Necrotizing / Q000139:chemically induced*; D005260:Female; D005602:France; D005654:Fundus Oculi; D006801:Humans; D007231:Infant, Newborn; D019102:Infant, Very Low Birth Weight; D008297:Male; D009184:Mydriatics / Q000008:administration & dosage* / Q000009:adverse effects*; D015997:Neonatal Screening; D009883:Ophthalmic Solutions; D010656:Phenylephrine / Q000008:administration & dosage* / Q000009:adverse effects*; D012178:Retinopathy of Prematurity / Q000175:diagnosis*; D012189:Retrospective Studies; D014331:Tropicamide / Q000008:administration & dosage* / Q000009:adverse effects*
D009184:Mydriatics; D009883:Ophthalmic Solutions; D010656:Phenylephrine; D014331:Tropicamide
Adverse effect; Dilatation pupillaire; Effet indésirable; Entérocolite ulcéronécrosante; Necrotizing enterocolitis; Phenylephrine; Phényléphrine; Pupillary dilation; Retinopathy of prematurity; Rétinopathie du prématuré; Tropicamide