Published online August 1, 2005
PEDIATRICS Vol. 116 No. 2 August 2005, pp. 385-391 (doi:10.1542/peds.2004-1807)
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A Controlled, Randomized, Double-Blind Trial of Prophylaxis Against Jaundice Among Breastfed Newborns

Glenn R. Gourley, MD*, Zhanhai Li, PhD{ddagger}, Bill L. Kreamer, BS§ and Michael R. Kosorok, PhD{ddagger}

* Department of Pediatrics, Oregon Health and Science University, Portland, Oregon
{ddagger} Department of Biostatistics and Medical Informatics
§ Waisman Center, University of Wisconsin, Madison, Wisconsin

Objectives. Neonatal jaundice is a greater problem for infants fed breast milk, compared with formula. This study tested the hypotheses that feeding breastfed newborns ß-glucuronidase inhibitors during the first week after birth would increase fecal bilirubin excretion and would reduce jaundice without affecting breastfeeding deleteriously.

Methods. Sixty-four breastfed newborns were randomized to 4 groups, ie, control or receiving 6 doses per day (5 mL per dose) of L-aspartic acid, enzymatically hydrolyzed casein (EHC), or whey/casein (W/C) for the first week. L-Aspartic acid and EHC inhibit ß-glucuronidase. Transcutaneous bilirubin levels (primary outcome) were measured daily (Jaundice Meter [Minolta/Air Shields, Hatboro, PA] and Bilicheck [Respironics, Pittsburgh, PA]). All stools were collected, and fecal bile pigments, including bilirubin diglucuronide, bilirubin monoglucuronides, and bilirubin, were analyzed with high-performance liquid chromatography. Follow-up assessments included day 7 body weight, day 6/7 prebreastfeeding/postbreastfeeding weights, maternal ratings, and ages at formula introduction and breastfeeding cessation.

Results. The groups were comparable at entry. Overall, the L-aspartic acid, EHC, and W/C groups had significantly lower transcutaneous bilirubin levels than did the control group (75.8%, 69.6%, and 69.2%, respectively, of the control mean, 8.53 mg/dL, at the bilirubin peak on day 4). The L-aspartic acid, EHC, and W/C groups had significantly lower transcutaneous bilirubin levels on days 3 to 7. Fecal bile pigment excretion was greatest in the L-aspartic acid group, significantly greater than control values. There were no significant differences in dosages, follow-up measurements, and maternal ratings.

Conclusions. Use of minimal aliquots of L-aspartic acid and EHC for ß-glucuronidase inhibition results in increased fecal bilirubin excretion and less jaundice, without disruption of the breastfeeding experience. Decreased jaundice in the W/C group, which lacked a ß-glucuronidase inhibitor, suggests a different mechanism.

Key Words: neonate • jaundice • hyperbilirubinemia • breastfeeding • ß-glucuronidase • bilirubin

Abbreviations: EHC, enzymatically hydrolyzed casein • W/C, whey/casein • HPLC, high-performance liquid chromatography • BMG, bilirubin monoglucuronide • BDG, bilirubin diglucuronide • BP, bile pigment • AAP, American Academy of Pediatrics

Accepted Nov 23, 2004.


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