Effect of chest shielding during phototherapy for hyperbilirubinemia on symptomatic patent ductus arteriosus - a double-blind randomized placebo-controlled trial.

BACKGROUND

Meta-analysis of randomized trials suggests that phototherapy is associated with patent ductus arteriosus (PDA). We hypothesized that chest shielding during phototherapy would decrease the incidence of symptomatic PDA (sPDA) compared to sham shielding.

METHODS

A single center, double-blind, randomized, placebo-controlled trial was performed to evaluate the effect of chest shielding during phototherapy on sPDA in infants ≤ 29 weeks gestational age (GA) or with birth weight (BW) ≤ 1000 g. Infants were randomized to either chest shield (with aluminum foil, intervention group) or sham shield (without aluminum foil, control group) during phototherapy. The primary outcome was sPDA during the period 24 h after phototherapy initiation until 3 days after phototherapy cessation.

RESULTS

160 infants were randomized with 10 infants withdrawn from each group due to shield placement after phototherapy initiation. Of 140 infants analyzed, the mean GA and BW was 26.6 weeks and 872 g, respectively. There was no difference in the incidence of sPDA between the intervention (n = 70) and control group (n = 70) (10% vs 11%, respectively, adjusted odds ratio 0.78, 95% CI:0.33-1.82; p = 0.57).

CONCLUSIONS

Chest shielding during phototherapy had no effect on sPDA in infants ≤ 29 weeks GA or with BW ≤ 1000 g.

TRIAL REGISTRATION: http://clinicaltrials.gov , Identifier: NCT02552927.

IMPACT: Meta-analysis of randomized clinical trials suggests that chest shielding during phototherapy used for hyperbilirubinemia may decrease the incidence of patent ductus arteriosus. The effect of chest shielding during phototherapy on symptomatic patent ductus arteriosus has not been evaluated in a double-blind randomized trial. In this double-blind, randomized, placebo-controlled trial, chest shielding during phototherapy was not associated with a decreased incidence of symptomatic patent ductus arteriosus in premature infants.