Glycerin Suppositories to Reduce Jaundice in Premature Infants
Condition: Idiopathic Hyperbilirubinemia; Neonatal Hyperbilirubinemia; Prematurity
MeSH terms: Premature Birth; Hyperbilirubinemia, Neonatal; Jaundice; Hyperbilirubinemia
Study type: Interventional

Summary: 
      The purpose of this study is to find out if giving glycerin suppositories will help decrease
      the length of time premature infants need phototherapy.

      The investigators hypothesize that glycerin suppositories (initiated along with phototherapy)
      will have no effect on reducing duration of phototherapy in premature infants with jaundice.
    

Detailed description: 
      Neonatal jaundice is one of the most common clinical problems in the neonatal period
      (Maisels). Physiologic hyperbilirubinemia is usually benign and transient in nature.
      Bilirubin overproduction, delayed hepatic clearance, and increased enterohepatic circulation
      of bilirubin all contribute to neonatal jaundice (Bader). Previous studies have shown that
      delayed meconium evacuation might be an important contributing factor in the development and
      persistence of neonatal jaundice (Rosta and Porto). Once conjugated bilirubin is excreted
      from the liver to the small intestine, it is often deconjugated in the presence of alkaline
      media and beta-glucorinase enzymes which are present in abundance in premature infants. Once
      deconjugated, unconjugated bilirubin is reabsorbed leading to entero-hepatic circulation,
      which plays a significant role in the development on neonatal jaundice.

      Previous studies have shown that early meconium evacuation was associated with lower total
      serum bilirubin levels and decreased risk for clinically significant neonatal jaundice
      (Jirsova, DeCarvalho, Boyer, Gourley, Salariya and Gourley). Other studies in healthy term
      neonates have shown no benefit from rectal glycerin in reducing peak serum bilirubin levels.
      Bader et al performed a prospective study to evaluate the general effect of glycerin
      suppository administration in reducing total serum bilirubin levels in healthy term neonates.
      Glycerin suppositories were given immediately after birth and every 4 hours thereafter, until
      evacuation of first stool. The suppositories had no effect on mean total serum bilirubin
      levels at 48 hours of age. It was concluded that glycerin suppositories should not be
      routinely recommended as a means for reducing the severity of neonatal jaundice. However, it
      was found that in a subgroup of male infants with blood group type A there were significantly
      lower mean total serum bilirubin levels after induction of earlier meconium evacuation with
      glycerin suppositories. Weisman et al performed a similar prospective study in healthy term
      neonates and found that giving glycerin suppositories does hasten the passage of meconium and
      transitional stool; however, there was no effect on peak serum bilirubin levels during the
      first 3 days of life and no effect on need for phototherapy. Chen et al described a
      prospective, randomized controlled trial with two groups of healthy term neonates. The
      experimental group received glycerin enemas at 30 minutes and 12 hours of life. Bilirubin
      levels were followed for the first 7 days of life. The intervention had no effect on peak
      serum bilirubin levels or serum bilirubin levels in the first 7 days of life.

      No data exist on the use of glycerin suppositories in premature neonates, although its use is
      a common practice to increase meconium clearance and stooling in the case of
      hyperbilirubinemia. However, it may not be a justified practice, based on data for full-term
      infants. Experts argue that premature neonates may have upward of 25% more enterohepatic
      circulation than full-term neonates (S. Amin, personal communication). Therefore, because
      premature neonates have the potential to recirculate bilirubin, increasing stool frequency
      through schedule glycerin suppositories might play a therapeutic role in the management of
      hyperbilirubinemia in this population.

      It is a common practice in our unit to provide glycerin suppositories every 8 hours to
      infants under phototherapy in an attempt to more rapidly reduce bilirubin levels by
      decreasing enterohepatic circulation of unconjugated bilirubin. This practice is not
      evidence-based, nor is it standard practice in many NICUs throughout the country. Glycerin
      suppositories are not without risk. They can lead to rectal fissures and tears, bloody stools
      and unnecessary vagal stimulation.

      If administration of glycerin shaves decreases length of phototherapy to a clinically
      significant extent, there may be improved success with feedings including breastfeeding,
      improved infant-parent bonding, shortened length of stay and overall increased family
      satisfaction. However, if glycerin suppositories are not shown to reduce duration of
      phototherapy, reduce peak total serum bilirubin (TSB) levels, reduce the number of TSB levels
      drawn and increase the rate of decline of hyperbilirubinemia, then a potentially useless
      therapy with potential for untoward side effects may be avoided.
    

Intervention name(s): Phototherapy; glycerin suppository
Intervention type(s): Procedure; Drug
Intervention description(s): Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools.; Promotes stooling through rectal stimulation and softening of stool. Given every 8 hours rectally. A pediatric glycerin suppository is 1.2 grams. All infants in this study arm will receive our standard dose of glycerin suppository which is 0.25 of the pediatric suppository or 0.3 grams.
Other intervention name(s): Bili light; glycerin shave
Intervention MeSH terms: Glycerol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: glycerin suppositories; glycerin shaves; neonatal hyperbilirubinemia; idiopathic hyperbilirubinemia; jaundice; neonatal jaundice; prematurity