Prophylactic indomethacin in extremely premature infants between 23 and 24 weeks gestation.
BACKGROUND
In extremely premature infants, the presence of a left-to-right shunt through a patent ductus arteriosus (PDA) increases the risks of pulmonary hemorrhage, intraventricular hemorrhage, necrotizing enterocolitis, renal failure, and chronic lung disease. Conservative management induces spontaneous ductus closure in <20% of extremely premature infants (infants born at <25 weeks of gestation). The aim of the present study was to determine the efficacy and safety of prophylactic indomethacin (INDO) administration for PDA closure in extremely premature infants born between 23 and 24 weeks of gestation.


METHODS
A historical case-control study of 30 infants born between 23 and 24 weeks of gestation was carried out. In the prophylactic INDO group, a 12 h-long, 0.01 mg/kg per h dose of INDO was administered within 6 h of life. During the historical control period, only infants with symptomatic PDA were treated with INDO for 1 h. The incidence of symptomatic PDA, mortality and early neonatal morbidity was compared between the two groups on Fisher's exact test and Mann-Whitney rank-sum test.


RESULTS
None of the infants in the prophylactic INDO group had symptomatic PDA, while 11 of the 15 infants in the control group showed symptomatic PDA (P < 0.001). There were no significant differences between the mortality rates and the early neonatal morbidities in the two groups.


CONCLUSIONS
Prophylactic INDO administration to extremely premature infants born between 23 and 24 weeks of gestation decreased the incidence of symptomatic PDA without increasing the incidence of adverse effects.
Department of Neonatology, Hyogo Prefectural Kobe Children's Hospital Perinatal Center, Kobe, Japan. yoshimoto_kch@hp.pref.hyogo.jp
Seiji
S
Yoshimoto
Hitomi
H
Sakai
Masaaki
M
Ueda
Mayumi
M
Yoshikata
Masami
M
Mizobuchi
Hideto
H
Nakao
D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage*; D016022:Case-Control Studies; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004373:Ductus Arteriosus / Q000187:drug effects; D004374:Ductus Arteriosus, Patent / Q000517:prevention & control*; D005260:Female; D005500:Follow-Up Studies; D005865:Gestational Age; D006801:Humans; D007213:Indomethacin / Q000008:administration & dosage*; D007231:Infant, Newborn; D007234:Infant, Premature; D019102:Infant, Very Low Birth Weight; D008297:Male; D011322:Primary Prevention / Q000379:methods; D012016:Reference Values; D018570:Risk Assessment; D018709:Statistics, Nonparametric; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal; D007213:Indomethacin