109 - Hyperbilirubinemia Risk Evaluation and Management by End-tidal Carbon Monoxide-corrected in Near-term and Term Chinese Neonates: A Randomized Controlled Clinical Trial

In addition to ABO hemolytic disease of the newborn, the Guangdong province has a disproportionally high prevalence of G6PD deficiency in China. It is therefore a common practice to assume that a jaundiced neonate may have hemolytic disease and lower the threshold for phototherapy. This conservative approach may result in overuse of phototherapy. End-tidal carbon monoxide-corrected (ETCOc) measurement has been shown to be a good surrogate marker for hemolysis.

Objective:

To determine whether the use of ETCOc measurement in addition to transcutaneous bilirubin (TCB) levels can decrease the rate of first phototherapy within 7 days of life (DOL) and whether it is associated with early identification of infants who are at a higher risk of requiring phototherapy.

Design/Methods:

We conducted a single-center randomized controlled trial (Hyperbilirubinemia Risk Evaluation and Management by ETCOc, HEME trial) with 1:1 parallel allocation in the well-baby nursery of Guangzhou Women and Children’s Medical Center from October, 2021 to July, 2022. Neonates who were born at ≥35 weeks’ gestational with birth weight ≥2000 grams, and had TCB >40^th percentile of Bhutani nomogram within 72 hours after birth were recruited. ETCOc were measured in both arms and infants allocated to the intervention arm received risk assessment based on ETCOc: a level ≤1.5 ppm indicates low risk, whereas a level >1.5 ppm indicates increased risk for hemolysis. The controls were managed per usual local practice with ETCOc level masked. The primary outcome was the rate of phototherapy within the first 7 DOL. Secondary outcomes included time to first phototherapy, TCB, total serum bilirubin and ETCOc level at the start of first phototherapy.

Results: Among 2,500 randomized infants, baseline characteristics were similar between the intervention group (n=1,252) and the controls (n=1,248) (Table 1).  Compared with controls, less infants in the intervention group received phototherapy within 7 DOL, especially in male infants and those born to non-blood type O mothers (Table 2). With similar TCB and total serum bilirubin level at the initiation of phototherapy, the intervention group started phototherapy earlier with higher ETCOc level (Table 3).  No acute bilirubin encephalopathy occurred in either group.

Conclusion(s): Risk assessment by ETCOc, compared with empirical assessment, can significantly decrease the rate of unnecessary phototherapy for hyperbilirubinemia and may be able to identify the infants requiring therapy earlier.