This study aimed to compare the efficacy and safety of intravenous Levetiracetam and Phenobarbitone in the treatment of seizures in preterm neonates. It was an open-labeled, parallel randomized controlled trial conducted in a tertiary Neonatal Intensive Care Unit, India. Total 48 preterm neonates (28-36 +6 weeks) with clinical seizures were randomized to receive either Levetiracetam (LEV; 40 mg/kg, then 20 mg/kg) or Phenobarbitone (PB; 15 mg/kg, then 10 mg/kg) intravenously as first loading dose in ratio 1:1; second loading was given for persistent seizure. Efficacy was denoted by cessation of clinical seizures with first or second doses of the allotted antiepileptic, and remaining seizure-free for the next 24 h. The demographic characteristics of preterm neonates and seizure types were comparable between both groups. Clinical seizure was controlled in 19 (79%) neonates in LEV group and 17 (70%) neonates in PB group, RR 1.12 (95% CI: 0.80 to 1.55), p = 0.504. There was increased respiratory support in PB group 9 (38%) vs. 3 (13%) in LEV group, RR 3.0 (95% CI: 0.92 to 9.74), p = 0.06.Conclusion: Levetiracetam and Phenobarbitone were equally efficacious for clinical neonatal seizure control, but increased respiratory support was found with Phenobarbitone use. What is Known:• Preterm neonates are at higher risk of neonatal seizure and Phenobarbitone is commonly used as the first line antiepileptic drugs in treating them. What is New:• Levetiracetam found equally efficacious as Phenobarbitone for cessation of clinical seizures in preterm neonates, with less adverse effect.

Background. Preterm neonates perceive multiple painful procedures during Neonatal Intensive Care Unit (NICU) stay, having long term neurobehavioral effects. This study aims to compare the analgesic efficacy of oral melatonin with 24% sucrose in neonates during retinopathy of prematurity (ROP) screening. Methods. A prospective, non-blinded, randomized controlled trial was conducted in a tertiary care NICU. All preterm neonates with gestational age (GA) < 34 weeks or birth weight (BW) < 2000 grams eligible for ROP screening were randomized into oral melatonin (4 mg/kg) and oral 24% sucrose (0.5 ml) groups. Both groups received standard non-pharmacological measures and topical proparacaine. The intensity of pain was measured by Premature Infant Pain Profile (PIPP) score during the procedure, at 1st and 5th minutes following the procedure and compared between the two groups by Mann-Whitney U test with p value < 0.05 considered as significant. Results. A total of 60 preterm neonates were randomized with 30 neonates in the melatonin (median [interquartile range] GA: 30.86 [3.78] weeks, BW: 1160 [430] grams) and 30 neonates in the 24% sucrose (median [IQR] GA: 29.29 [4.68] weeks, BW: 1070 [315] grams) group. The median PIPP score during the procedure in the melatonin and sucrose groups were 17 and 16, respectively (p=0.64). The median (Q1-Q3) PIPP score at the 1st minute was significantly lower among the melatonin group (7 [5.25-10]) vs 24% sucrose group (9.5 [7.25-11]) (p=0.02); and at the 5th minute, the median (Q1-Q3) PIPP scores in the melatonin group (5 [4-6]) was comparable to the 24% sucrose group (5.5 [3.25-7]) (p= 0.52). Conclusions. Oral melatonin is not inferior to oral 24% sucrose for pain management during ROP screening.

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