Design: Randomized (randomization table), double-blinded (supplements were prepared by a third party and labeled by a code) controlled trial.
Setting: Clinic.
Patients: 69 newborns, Caucasian, >37 week of gestation who were exclusively breastfed.
Intervention: Patients were randomly assigned to four groups: breastfeeding only (control), L-aspartic acid supplementation (L-aspartic), enzymatically hydrolyzed casein (EHC), and whey/casein-supplement without beta-glucuronidase inhibitor (W/C).
Main outcome measure: Daily transcutaneous and fecal bilirubin levels were obtained. Long-term follow-up assessments included age at first formula feeding, breastfeeding cessation age, and mother’s subjective impression of study.
Main results: Infants in all supplementation groups had significantly lower transcutaneous bilirubin levels in the first week of life than the nonsupplemented infants. The EHC and W/C groups both excreted more bilirubin diglucuronide and bilirubin monoglucuronide than the control group, and the L-aspartic acid had increased bilirubin monoglucuronide excretion compared with the control group. No negative effects from the supplementations were noted.
Conclusions: There is a significant reduction in transcutaneous bilirubin levels, with no negative effects on breastfeeding through the administration of specific supplements that are currently found in infant formulas.
Conflict of interest: None declared.
Commentary: The study describes a possible method of reducing hyperbilirubinemia associated with breastfeeding that employs small-volume supplementations of ingredients found in common infant formulas. The study did not reveal any negative effects on breastfeeding. Though the study was described as blinded the authors do not comment on how the exclusively breastfed infant group was blinded from the researchers and family.
The other control group (W/C) not fed a supplement without a beta-glucuronidase inhibitor yielded the unexpected significant reduction in transcutaneous bilirubin level compared with the control. This may mean that there is at least one other mechanism for the reduction of bilirubin in formula-fed infants than initially proposed by the authors.
In their conclusion, the authors pose a hypothesis explaining this result. They also correctly point out that due to this small study population, larger studies are needed to confirm these results.
This study used transcutaneous bilirubin measurements raising the question of reliability of this method compared to serum bilirubin measurements. A search of Medline using the terms “bilirubin and transcutaneous” produced a technical report.1 One section of this article reviewed available studies on the accuracy of transcutaneous bilirubin measurements concluding that the transcutaneous measurement has a linear correlation to serum bilirubin and its use for hyperbilirubinemia screening is reliable.
Reference
Ip S, Chung M, Kulig J, et al. American Academy of Pediatrics Subcommittee on Hyperbilirubinemia. An evidence-based review of important issues concerning neonatal hyperbilirubinemia. Pediatrics. 2004;Jul;114(1):e130-153.
Comparing Controllers: Montelukast and Fluticasone in Mild Persistent Asthma
Garcia Garcia ML, Wahn U, Gilles L, et al. Montelukast, compared with fluticasone, for control of asthma among 6- to 14-year-old patients with mild asthma: the MOSAIC study. Pediatrics. 2005;116(2):360-369.
Question: In children with mild asthma is the use of an antileukotriene medication as effective as an anti-inflammatory agent in maintaining number of days without the need of a rescue medication or utilization of asthma-related health resources?
Design: Multicenter, double-blind, double-dummy, randomized, parallel-group study. A four-week, single-blind, placebo run-in period was done prior to the initiation of the double-blind portion of the study. This run-in period included three clinic visits. During this time all participants discontinued any asthma controller medications and received image-matching, single-blind, montelukast and fluticasone. A short acting beta-agonist medication (open label) was also provided. Medication usage teaching was done during this time period. There was no placebo control group.