Comparison of efficacy, safety & satisfaction of intermittent versus continuous phototherapy in hyperbilirubinaemic newborns ≥35 week gestation: A randomized controlled trial.

BACKGROUND &

OBJECTIVES

Phototherapy (PT) has become the standard of care for treating neonatal jaundice. This study was aimed to find out if intermittent PT (IPT) results in comparable rate of fall of bilirubin level to continuous PT (CPT) and results in lesser side effects and better acceptance.

METHODS

In this non-inferiority trial, 174 neonates ≥35 wk gestation and >2000 g with jaundice requiring PT were randomized to receive either IPT (one hour on and two hours off) or CPT (with minimum interruptions for feeding) after device stratification [light-emitting diode (LED) or compact fluorescent light (CFL)]. Bilirubin was checked 12th hourly, and calcium, vitamin D and nitric oxide (NO) levels were analyzed along with the clinical side effects and nursing and maternal satisfaction scores (CTRI Registration No. CTRI/2018/01/011072).

RESULTS

The rate of fall of bilirubin was similar in both the CPT and IPT groups [0.16 (0.10, 0.22) vs. 0.13 (0.09, 0.20) mg/dl/h, P=0.22]. The median difference with 95 per cent confidence interval of 0.03 (0.03, 0.03) mg/dl was also within the pre-defined inferiority limits. There was no significant change in the duration of PT and side effects such as fall in calcium levels, rise in vitamin D and NO levels or the clinical side effects. Maternal satisfaction favoured the IPT group, but the nurses opined that IPT was difficult to implement. Subgroup analysis for PT devices used showed that efficacy of both CFL and LED devices was equivalent.

INTERPRETATION &

CONCLUSIONS

IPT was non-inferior to CPT in reducing bilirubin levels in ≥35 wk neonates, irrespective of device used, and also mothers reported better satisfaction with IPT. Although IPT appears promising, CPT does not increase clinical and biochemical side effects compared to IPT.