From the Guidelines
Ibuprofen should be used with caution in newborns and the recommended dose is 2 mg/kg for infants less than 6 months of age, as stated in the study published in Pediatrics in 2008 1. When considering the use of ibuprofen in newborns, it is essential to weigh the potential benefits against the risks, including immature kidney function, increased risk of gastrointestinal bleeding, and potential adverse effects on the developing cardiovascular system. Key points to consider when administering ibuprofen to newborns include:
- The dose of 2 mg/kg for infants less than 6 months of age, as recommended in the study 1
- The potential risks and side effects, such as gastrointestinal bleeding and adverse effects on the developing cardiovascular system
- The importance of consulting with a pediatrician before administering any medication to a newborn, as they will provide guidance based on the specific clinical situation and the infant's health status In specific medical circumstances, such as patent ductus arteriosus closure in premature infants, ibuprofen may be used under strict specialist supervision at specific doses, but this is a specialized hospital-based treatment not meant for routine use. The use of ibuprofen in newborns requires careful consideration of the potential risks and benefits, and should only be done under the guidance of a pediatrician, taking into account the specific clinical situation and the infant's health status, as supported by the study published in Pediatrics in 2008 1.
From the Research
Ibuprofen Dosage for Newborns
- The dosage of ibuprofen for newborns, specifically for the treatment of patent ductus arteriosus (PDA), has been studied in various clinical trials 2, 3, 4, 5, 6.
- According to a study published in 2004, newborns were randomized to receive ibuprofen or placebo for the prophylactic treatment of PDA at an initial dose of 10 mg/kg ibuprofen within 6 hours after birth, followed by two 5-mg/kg doses at 24-hour intervals 2.
- Another study published in 2018 suggested that a first dose of 20 mg/kg followed by 10 mg/kg every 24 hours is effective, but also proposed an alternative dosing regimen of 18 mg/kg as the first dose, followed by 4 mg/kg every 12 hours, with an increase to 5 mg/kg every 12 hours after 96 hours postnatal age 3.
- A systematic review published in 2006 recommended a starting dose of 10 mg/kg followed by 5 mg/kg/d for 2 more days for optimal efficacy with the least adverse effects 4.
- A study published in 2012 compared oral and intravenous ibuprofen and found that both forms are effective, but oral ibuprofen may have a higher incidence of sepsis and bronchopulmonary dysplasia 5.
- A Cochrane review published in 2013 found that ibuprofen is as effective as indomethacin in closing a PDA and reduces the risk of necrotizing enterocolitis (NEC) and transient renal insufficiency 6.
Dosage Recommendations
- Initial dose: 10 mg/kg ibuprofen within 6 hours after birth 2
- Alternative initial dose: 20 mg/kg followed by 10 mg/kg every 24 hours 3
- Proposed alternative dosing regimen: 18 mg/kg as the first dose, followed by 4 mg/kg every 12 hours, with an increase to 5 mg/kg every 12 hours after 96 hours postnatal age 3
- Recommended dosing regimen: 10 mg/kg followed by 5 mg/kg/d for 2 more days 4