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.

Effect of phototherapy on oxidant/antioxidant status: a randomized controlled trial.

In order to evaluate the effect of different types of phototherapy on oxidant/antioxidant status in hyperbilirubinemic neonates, an interventional randomized control trial was conducted on 120 neonates ≥35 weeks' gestational age with indirect hyperbilirubinemia reaching phototherapy level. This study is registered with ClinicalTrials.gov as NCT03074292. Neonates were assigned to three groups; 40 neonates received conventional phototherapy, 40 received intensive phototherapy and 40 received blue light-emitting diodes (LED) phototherapy. Complete blood count (CBC), total serum bilirubin (TSB), total antioxidant capacity (TAC), malondialdehyde (MDA), nitric oxide (NO), copper (Cu), zinc (Zn), and iron (Fe) levels were measured before and 24 hours after phototherapy. TSB decreased postphototherapy in all three groups (p < .05 for all), with significantly lower levels following intensive and LED phototherapy compared to conventional phototherapy (p < .05 for both). TAC decreased postphototherapy in the three groups (p < .05 for all). MDA and NO increased postphototherapy (p < .05 for all), with the intensive phototherapy group having the highest levels followed by the conventional while LED phototherapy group showed the lowest levels in comparison to the other groups (p < .05). Cu, Zn and Fe increased postphototherapy in all three groups (p < .05 for all). Positive correlations were found between postphototherapy TSB with TAC, Cu and Zn (p < .05) and negative correlations with MDA, NO and Fe (p < .05) among neonates of the 3 studied groups. In conclusion, different photo therapies have an impact on oxidant/antioxidant balance and are associated with increased oxidative stress markers with the LED phototherapy being the safest.

Cerebral blood flow and serum neuron-specific enolase in early-onset neonatal sepsis.

BACKGROUND AND OBJECTIVES: Sepsis leads to systemic inflammatory response with cerebral blood flow (CBF) alteration and blood-brain barrier disruption that contribute to sepsis-associated encephalopathy (SAE). We aimed to evaluate cord blood neuron-specific enolase (cNSE) and CBF in early-onset neonatal sepsis (EONS) as predictors of SAE and to define short-term neurodevelopmental outcomes among survivors. METHODS: cNSE was measured in 200 neonates with antenatal risk factors for EONS, stratified into two groups: sepsis (n = 96) and no-sepsis (n = 104). Trans-cranial Doppler of peak systolic velocities (PSV), end diastolic velocities (EDV) and resistive indices (RI) of anterior (ACA) and middle (MCA) cerebral arteries recorded on day 1 postnatal. Griffiths mental developmental scale (GMDS) was assessed at 6 months. RESULTS: Increased cNSE, PSV, EDV, and decreased RI of both ACA and MCA were found in sepsis group compared to no-sepsis group (p < 0.001 for all). Patients with SAE (n = 34) had higher NSE, PSV, and EDV as well as lower RI of ACA and MCA compared to those without (p < 0.01 for all). SAE neonates had lower GMDS than those without. ACA RI of ≤0.61 was the best predictor of SAE. CONCLUSION: High CBF and cNSE could be useful markers for prediction of SAE. SAE impairs neurodevelopmental scales at 6 months.