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Published on: January 27, 2023
Oral Ibuprofen and ductus arteriosus in premature infants: a randomized pilot study
Hany Aly1, Wael Lotfy, Nadia Badrawi
1Newborn Services Department, The George Washington University Hospital, Washington, District of Columbia 20037, USA.
Insights
Oral ibuprofen suspension (OIS) is a feasible and effective treatment for premature infants with patent ductus arteriosus (PDA). This study found OIS comparable to intravenous indomethacin, with fewer adverse events like pulmonary hemorrhage.
Area of Science:
- Neonatal Medicine
- Pediatric Cardiology
- Pharmacology
Background:
- Patent ductus arteriosus (PDA) is a common condition in premature infants, often requiring medical intervention.
- Intravenous indomethacin is a standard treatment, but carries risks and administration challenges.
- Exploring alternative, easier-to-administer treatments is crucial for improving outcomes in neonates.
Purpose of the Study:
- To assess the feasibility and efficacy of oral ibuprofen suspension (OIS) for treating PDA in premature infants.
- To compare OIS with intravenous (IV) indomethacin in terms of PDA closure rates and safety.
- To evaluate the impact of both treatments on laboratory parameters and adverse events.
Main Methods:
- A randomized controlled trial involving premature infants (≤35 weeks) diagnosed with PDA.
- Infants received either IV indomethacin or OIS.
- Echocardiography (ECHO) was used to measure ductal parameters before and after treatment.
- Laboratory values (hematocrit, platelets, BUN, creatinine) and adverse events were monitored.
Main Results:
- PDA closure rates were high and similar between groups: 78% for IV indomethacin and 83% for OIS.
- Infants receiving IV indomethacin showed a significant decrease in hematocrit compared to OIS.
- No infants in the OIS group experienced severe pulmonary hemorrhage, unlike two in the IV indomethacin group.
Conclusions:
- Oral ibuprofen suspension is a viable and effective alternative for treating PDA in premature infants.
- OIS demonstrates a favorable safety profile, with a lower incidence of severe pulmonary hemorrhage.
- The ease of administration makes OIS a promising option for neonatal care.
Abstract:
The purpose of this study was to evaluate the feasibility of the use oral ibuprofen suspension (OIS) in the treatment of patent ductus arteriosus (PDA) in premature infants. Premature infants (= 35 weeks) age 2 to 7 days who suffered from respiratory distress and had been diagnosed with PDA were included in this study. Color Doppler echocardiography (ECHO) was used to measure the internal ductal diameter, pressure gradient, and the ratio of left atrial to aortic root diameters (La/Ao). Infants were randomly assigned to one of two groups: group I received three doses of intravenous (IV) indomethacin (0.2 mg/kg at 12-hour intervals) and group O received an initial dose of OIS (10 mg/kg), followed by two doses of 5 mg/kg each, after 24 and 48 hours. A follow-up ECHO was done after treatment by the same pediatric cardiologist who was blinded to the assignment of the study groups. Changes in blood platelet count, hematocrit, blood urea nitrogen, and creatinine were compared between groups. In total, 78 premature infants were screened: 21 had been diagnosed with PDA. Infants in group I (n = 9) and group O (n = 12) did not differ in birthweight (1884 +/- 485 versus 1521 +/- 398 g [mean +/- SD]; P = 0.13), gestational age (32.9 +/- 1.6 versus 31.2 +/- 2.5 weeks; P = 0.07), internal diameter of PDA (2.3 +/- 0.5 versus 2.1 +/- 0.5 mm; P = 0.34), pressure gradient across PDA (12.83 +/- 6.46 versus 11.11 +/- 4.5 mm Hg; P = 0.48), and La/Ao ratio (1.26 +/- 0.21 versus 1.17 +/- 0.12; P = 0.25). Closure of PDA was achieved in 78% (seven of nine) of infants in group I and in 83% (10 of 12) of infants in group O. Comparisons of laboratory changes following treatment in group I and group O were as follows: decrease in hematocrit (-6.5 +/- 6.6 versus -1.2 +/- 4.2; P = 0.04) and in platelet count (-54 +/- 67 versus -1 +/- 53 x 10 (3)/muL; P = 0.24), and increase in blood urea nitrogen (16.4 +/- 16.4 versus 2.1 +/- 17.4 mg/dL; P = 0.06) and serum creatinine (0.12 +/- 0.22 versus -0.06 +/- 0.19 mg/dL; P = 0.13). Two infants in group I had severe pulmonary hemorrhage, whereas there were none in the group O. Oral ibuprofen could be an easy-to-administer and efficacious alternative in the treatment of PDA.
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