Published online December 1, 2008
PEDIATRICS Vol. 122 No. 6 December 2008, pp. e1256-e1261 (doi:10.1542/peds.2008-1780)
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ARTICLE

Randomized Pilot Study Comparing Oral Ibuprofen With Intravenous Ibuprofen in Very Low Birth Weight Infants With Patent Ductus Arteriosus

Ahmed Cherif, MD, Naima Khrouf, MD, Sami Jabnoun, MD, Chahnez Mokrani, MD, Moez Ben Amara, MD, Nedia Guellouze, MD and Samia Kacem, MD

Neonatal Intensive Care Unit, Neonatology and Maternity Center, Faculty of Medicine, Department of Neonatology, University of Tunis, Tunis, Tunisia

BACKGROUND. We conducted a prospective, randomized, single-masked pilot study with the principal aim of comparing efficacy and tolerance between oral and intravenous ibuprofen in early closure of patent ductus arteriosus in very low birth weight infants. The possibility of ductal closure with only 1 or 2 doses of treatment was a secondary objective.

MATERIAL AND METHODS. Sixty-four very low birth weight patients with echocardiographically confirmed patent ductus arteriosus and respiratory distress were studied. The patients were randomly assigned to receive either oral (group O, n = 32) or intravenous (group I, n = 32) ibuprofen starting on the third day of life. After the first dose of treatment in both groups, echocardiographic evaluation was performed to determine the need for a second or third dose. The rate of ductal closure, adverse effects, complications, and the patient's clinical course were recorded.

RESULTS. In each group, 24 (75%) patients were born after 28 weeks' gestation. The rate of ductal closure tended to increase in group O (84.3% vs 62.5%). Closure of the ductus was obtained after 1 or 2 doses of treatment in 19 (70.3%) of 27 patients in group O and 14 (70%) of 20 patients in group I. The adverse effects were increased in group I (31.2% vs 9.3%). There were no significant differences with respect to complications during the stay. Adverse effects were significantly fewer when closure was achieved after an incomplete course of treatment (23.1% vs 76.9%).

CONCLUSIONS. In very low birth weight infants, the rate of early ductal closure with oral ibuprofen is at least as good as with the intravenous route. Ductal closure may be obtained with an incomplete course of ibuprofen. Oral ibuprofen is associated with fewer adverse effects. However, a larger sample is needed for more definitive conclusions.

Key Words: ibuprofen • ductus arteriosus • premature infant

Abbreviations: PDA—patent ductus arteriosus • VLBW—very low birth weight • IVH—intraventricular hemorrhage • NEC—necrotizing enterocolitis • CLD—chronic lung disease • GEB— gastrointestinal bleeding • PVL—periventricular leukomalacia

Accepted Aug 7, 2008.


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More accurate measures of efficacy should be required for reporting clinical trials
Daniel Virella, et al.
Pediatrics Online, 27 Jan 2009 [Full text]