A controlled, randomized, double-blind trial of prophylaxis against jaundice among breastfed newborns

Glenn R Gourley1, Zhanhai Li, Bill L Kreamer

  • 1Department of Pediatrics, Oregon Health and Science University, Portland, Oregon 97239-2998, USA. gourleyg@ohsu.edu

Pediatrics
|August 3, 2005
PubMed

Insights

Beta-glucuronidase inhibitors like L-aspartic acid and enzymatically hydrolyzed casein (EHC) reduced newborn jaundice in breastfed infants. These treatments increased fecal bilirubin excretion without negatively impacting breastfeeding.

Area of Science:

  • Neonatal care
  • Pediatric gastroenterology
  • Biochemistry

Background:

  • Neonatal jaundice is a common condition, particularly in breastfed infants.
  • Breast milk contains beta-glucuronidase, which can contribute to elevated bilirubin levels.
  • Effective interventions are needed to manage jaundice without compromising breastfeeding.

Purpose of the Study:

  • To investigate the efficacy of beta-glucuronidase inhibitors in reducing neonatal jaundice in breastfed newborns.
  • To assess the impact of these inhibitors on fecal bilirubin excretion.
  • To determine if treatment affects the breastfeeding experience.

Main Methods:

  • Sixty-four breastfed newborns were randomized into four groups: control, L-aspartic acid, enzymatically hydrolyzed casein (EHC), or whey/casein (W/C).
  • Interventions were administered for the first week of life.
  • Transcutaneous bilirubin levels were measured daily, and fecal bile pigments were analyzed using high-performance liquid chromatography.

Main Results:

  • L-aspartic acid, EHC, and W/C groups showed significantly lower transcutaneous bilirubin levels compared to the control group.
  • Fecal bile pigment excretion was significantly higher in the L-aspartic acid group.
  • No significant differences were observed in body weight, feeding weights, or maternal ratings across groups.

Conclusions:

  • L-aspartic acid and EHC effectively reduce neonatal jaundice by increasing fecal bilirubin excretion.
  • These interventions do not adversely affect the breastfeeding experience.
  • The W/C group's reduced jaundice suggests a potential alternative mechanism for jaundice reduction.
Abstract

Related Concept Videos

Blinding01:11

Blinding

Blinding is a commonly used method of not telling participants which treatment a subject is receiving. Blinding is a critical part of a randomized control trial or RCT. It reduces the bias that affects the results. In an RCT, blinding is used in the form of a placebo. A placebo effect occurs when untreated subjects falsely believe they have received the treatment and report improved symptoms. A placebo or a dummy treatment is administered to subjects to negate the bias caused by such an effect.
Bioavailability Study Design: Healthy Subjects Versus Patients01:15

Bioavailability Study Design: Healthy Subjects Versus Patients

Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
Drug Dosing: Infants and Children01:29

Drug Dosing: Infants and Children

Pediatric patient dosages diverge from adults due to disparities in body surface area, total body water, and extracellular fluid per kilogram of body weight. The dosing regimen considers the variations in pharmacokinetics and pharmacology across distinct age groups, encompassing preterm newborns, infants, young children, older children, and adolescents. Calculation of pediatric patient doses is predicated on determining body surface area, which exhibits a superior correlation with the child's...
Bioavailability Study Design: Single Versus Multiple Dose Studies01:11

Bioavailability Study Design: Single Versus Multiple Dose Studies

Bioavailability studies are essential for understanding how a drug is absorbed, distributed, metabolized, and excreted in the body. These studies assess the extent and rate at which the active pharmaceutical agent becomes available at the site of action. The design of bioavailability studies can involve single-dose or multiple-dose regimens, each with distinct advantages and limitations.Single-dose studies are the preferred approach due to their simplicity and reduced drug exposure for...
Jaundice01:25

Jaundice

Jaundice, or icterus, is the yellow discoloration of the skin, sclerae, and mucous membranes. It happens when plasma bilirubin levels rise above 2.5-3 mg/dL, leading to bilirubin deposition in tissue.Bilirubin is a byproduct of hemoglobin degradation. In macrophages, hemoglobin breaks down into globin and heme. Globin is converted into amino acids, while heme is turned into biliverdin by heme oxygenase, which is then reduced to unconjugated bilirubin by biliverdin reductase.Unconjugated...
Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs01:20

Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs

Bioequivalence experimental study designs are crucial methodologies used in evaluating and comparing the bioavailability of different drug products. These designs are categorized into various types: completely randomized, randomized block, repeated measures, cross and carry-over, and Latin square designs.Completely randomized designs involve randomly allocating treatments to all subjects participating in the experiment. This allocation is achieved by assigning unique random numbers to subjects...