Efficacy and safety of oral paracetamol versus oral ibuprofen for closure of patent ductus arteriosus in preterm infants: a randomized controlled trial.

Objective: The objective of this study is to evaluate the efficacy and safety of oral paracetamol versus oral ibuprofen in the treatment of hemodynamically significant patent ductus arteriosus (hsPDA) in preterm infants. Study design: An interventional randomized case-control study, registered in ClinicalTrials.gov (NCT03265782), was conducted on 60 preterm infants with gestational age ≤34 weeks, postnatal age of 2-7 d and color Doppler echocardiographic evidence of hsPDA. Neonates were randomly assigned to two groups: 30 received oral ibuprofen and 30 received oral paracetamol. With failure of ductal closure, a second course of ibuprofen or paracetamol was given. The included newborns were subjected to detailed history, clinical examination, laboratory investigations that included complete blood count, renal, and liver function tests and echocardiographic evaluation. Results: Oral paracetamol was as effective as ibuprofen for the closure of patent ductus arteriosus (PDA) with one course of treatment (p > .05). Moreover, oral paracetamol was superior to ibuprofen among neonates who needed second course of treatment with significant decrease in end diastolic flow velocity in the left pulmonary artery (0.35 ± 0.09 versus 0.19 ± 0.06, p = .014), right ventricular systolic pressure (40.50 ± 12.91 versus 20.50 ± 0.58, p = .016) and left atrium to aortic root ratio (1.23 ± 0.14 versus 1.07 ± 0.04, p = .046) when compared to ibuprofen group. Furthermore, the mean difference between pre- and post-treatment PDA size was significantly higher in the paracetamol group compared with ibuprofen group after the second course of treatment (1.07 ± 0.32 versus 0.73 ± 0.38, p = .024). Oral paracetamol was comparable with ibuprofen in terms of the rate of non-surgical ductal closure [28 (93.3%) versus 24 (80%), p = .591]. In addition, oral paracetamol was as safe as oral ibuprofen in terms of gastrointestinal perforation or bleeding, necrotizing enterocolitis, bronchopulmonary dysplasia, intraventricular hemorrhage, thrombocytopenia, hepatic or renal dysfunction. Conclusions: Oral paracetamol is an effective and well-tolerated first-line drug treatment for PDA in premature infants.

Hypocalcemic seizures in breastfed infants with rickets secondary to severe maternal vitamin D deficiency.

This study was done to evaluate if nursing mothers of infants with rickets have vitamin D deficiency, and to evaluate the relationship between maternal vitamin D levels with hypocalcemic seizures in infants with rickets. We selected a cohort of breastfed infants with rickets. Infants were included in this study if they were breastfed and presented with any of the following clinical criteria: delayed motor milestones or delayed teething, were found to have specific rachitic bony signs, or presented with hypocalcemic seizures. We checked serum calcium (Ca), phosphorus (P), alkaline phosphatase, 25 hydroxy vitamin D [25(OH)D] and parathyroid hormone (PTH) levels in both infants and their mothers. Out of 32 children who met the clinical criteria for rickets, 23 (72%) had vitamin D level less than 20 ng mL(-1). Twenty two mothers (69%) had vitamin D deficiency (25 hydroxy vitamin D < 20 ng mL(-1)). Mothers of nine infants who presented with hypocalcemic seizures had severe vitamin D deficiency, (p = 0.005). We conclude that maternal vitamin D deficiency is common in nursing mothers of infants diagnosed with rickets. Invariably mothers of infants presenting with hypocalcemic seizures have severe vitamin D deficiency. Hypocalcemic seizures in infants secondary to maternal vitamin D deficiency might be prevented by supplementation of vitamin D.