ABSTRACT
Objective: To compare the efficacy of enteral paracetamol and intravenous indomethacin for closure of patent ductus arteriosus (PDA) in preterm neonates. Design: Randomized controlled trial. Setting: Level III neonatal intensive care unit. Participants: 77 preterm neonates with birth weight ≤1500 g and PDA size ≥1.5 mm, with left to right ductal flow with left atrium to aortic root ratio >1.5:1; diagnosed by 2D-Echo within first 48 hours of life. Intervention: Paracetamol drops through the infant feeding tube (15mg/kg/dose 6 hourly for 7 days) or intravenous indomethacin (0.2 mg/kg/dose once daily for 3 days). Outcome measures: Primary: PDA closure rate assessed by echocardiography. Secondary: need for surgical closure of PDA, renal impairment, gastrointestinal bleed, necrotising enterocolitis, hepatotoxicity, pulmonary hemorrhage, sepsis, hypothermia, retinopathy of prematurity, intraventricular hemorrhage, bronchopulmonary dysplasia and mortality. Results: PDA closure rate was 100% (36/36) in enteral paracetamol group as compared to 94.6% (35/37) in intravenous indomethacin group (P=0.13). The secondary outcomes were also similar between the two groups. There was no occurrence of hepatotoxicity. Conclusions: Enteral paracetamol is safe but not superior to intravenous indomethacin in the treatment of PDA in preterm neonates.
ABSTRACT
Objective: To compare the efficacy of glycerin suppository versus no suppository in preterm very-low-birthweight neonates for improving feeding tolerance. Design: Randomized controlled trial. Setting: Level III neonatal unit from Mumbai, India. Participants: 50 very-low-birthweight (birth weight between 1000 to 1500 grams) preterm (gestational age between 28 to 32 weeks) neonates randomized to glycerine suppository (n=25) or no intervention (n=26). Intervention: Glycerin suppository (1g) once a day from day-2 to day-14 of life or no suppository, along with intermittent oral feeds and standardized care. Primary outcome: Time required to achieve full enteral feeds (180 mL/kg/d). Results: Baseline characteristics of neonates like gestational age, birthweight, gender and age at the time of introduction of feeds were comparable in both groups. The mean (SD) duration to reach full enteral feed was 11.90 (3.1) days in glycerin suppository group and was not significantly different (P=0.58) from control group, [11.33 (3.57) days]. Glycerin suppository group regained birth weight 2 days earlier than control group but this difference was not significant (P=0.16). There was no significant difference in duration of hospital stay or occurrence of necrotizing enterocolitis amongst the two study groups. Conclusion: Once daily application of glycerin suppository does not accelerate the achievement of full feeds in preterm very-lowbirthweight neonates.