Impact of oral versus intravenous ibuprofen on neurodevelopmental outcome: a randomized controlled parallel study
Zeynep Eras1, Tulin Gokmen, Omer Erdeve
1Developmental Behavioral Pediatrics Unit of Developmental Behavioral Pediatrics, Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey.
Insights
Oral ibuprofen for patent ductus arteriosus in preterm infants showed similar long-term neurodevelopmental outcomes compared to intravenous ibuprofen. This study provides valuable data on the safety and efficacy of oral ibuprofen for this common condition.
Area of Science:
- Neonatal medicine
- Developmental pediatrics
- Pharmacology
Background:
- Patent ductus arteriosus (PDA) is common in preterm infants.
- Intravenous indomethacin and ibuprofen are established PDA treatments.
- Long-term neurodevelopmental effects of oral ibuprofen for PDA are not well-documented.
Purpose of the Study:
- To compare the long-term neurodevelopmental outcomes of preterm infants treated with oral versus intravenous ibuprofen for PDA.
- To assess neurological, neurosensory, and cognitive impairments at 18-24 months corrected age.
Main Methods:
- Follow-up study of 99 infants (birth weight ≤ 1,500 g, gestational age ≤ 32 weeks) with PDA treated with oral or IV ibuprofen.
- Neurodevelopmental outcomes assessed at 18-24 months corrected age.
- Outcomes included cerebral palsy, hearing loss, blindness, and cognitive impairment (MDI < 70).
Main Results:
- Long-term outcomes of 30 infants receiving oral ibuprofen were compared to 27 receiving IV ibuprofen.
- No significant differences were found in neurological, neurosensory, or cognitive outcomes between the two groups.
- Examiners were blinded to treatment group allocation.
Conclusions:
- Oral ibuprofen for PDA in preterm infants results in similar neurodevelopmental outcomes at 2 years of age compared to intravenous ibuprofen.
- Oral ibuprofen is a viable alternative treatment for PDA in preterm infants with comparable long-term neurodevelopmental profiles.
Objective:
Although neurodevelopmental outcomes related to the management of patent ductus arteriosus with intravenous indomethacin and ibuprofen are known, little data on the long-term effects of oral ibuprofen can be found in the literature.
Method:
A follow-up study of 99 infants with birth weight ≤ 1,500 g and gestational age ≤ 32 weeks who received either oral or intravenous ibuprofen for patent ductus arteriosus was conducted to assess at 18 to 24 months (corrected age), abnormal neurological, neurosensory, and cognitive impairment were defined as follows:neurological outcomes included moderate/severe cerebral palsy, neurosensory outcomes included bilateral hearing loss and blindness in either eye, and cognitive impairment included mental developmental index score < 70.
Results:
The 18- to 24-month (corrected age) long-term outcomes of 30 subjects who received oral ibuprofen were compared with 27 subjects who received intravenous ibuprofen by certified and experienced examiners who were blind to the definitions of the groups. The results revealed that the long-term outcomes of the treatment regimens did not significantly differ.
Conclusions:
Preterm infants who were treated with oral ibuprofen for patent ductus arteriosus had similar neurological, neurosensory, and cognitive outcomes to patients who received intravenous ibuprofen at 2 years of age.
Related Concept Videos
Factors Affecting Drug Response: Overview
Drug Dosing: Infants and Children
Bioavailability Study Design: Single Versus Multiple Dose Studies
Drug Accumulation During Multiple Dosing: Intermittent IV Infusions
Bioavailability Study Design: Healthy Subjects Versus Patients
Pharmacokinetics in Pediatric Patients: Drug Metabolism

