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Glycerin Suppositories to Reduce Jaundice in Premature Infants

Primary Purpose

Idiopathic Hyperbilirubinemia, Neonatal Hyperbilirubinemia, Prematurity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Phototherapy
glycerin suppository
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Hyperbilirubinemia focused on measuring glycerin suppositories, glycerin shaves, neonatal hyperbilirubinemia, idiopathic hyperbilirubinemia, jaundice, neonatal jaundice, prematurity

Eligibility Criteria

30 Weeks - 35 Weeks (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Baby born between 30 to 34 6/7 weeks gestational age (GA) at birth and admitted to NICU
  2. Baby with physiologic hyperbilirubinemia requiring phototherapy by current NICU criteria.
  3. Parental permission.

Exclusion Criteria:

  1. Babies less than 30 weeks GA or greater than 34 6/7 weeks GA
  2. Non-physiologic hyperbilirubinemia: (1) positive Coombs test and (2) hematocrit < 5th percentile for GA (see Jopling J, Henry E, Wiedmeier SE, Christensen RD, Reference. Ranges for Hematocrit and Blood Hemoglobin Concentration During the Neonatal Period: Data From a Multihospital Health Care System. Pediatrics 2009; 123(2):e333 -e337.) and (3) ABO or Rh incompatibility.
  3. Any infant with bilirubin level within 2 mg/dL of exchange transfusion.
  4. Any infant who has phototherapy started prior to reaching light level (prophylactic)
  5. Baby with any GI abnormalities such as NEC, intestinal perforation, gastroschisis, omphalocele, malrotation and or volvulus, duodenal atresia, intestinal strictures/adhesions, imperforate anus.
  6. Any infant begun on triple or greater phototherapy at time of initiation of treatment.
  7. Any infant judged by the attending physician to be placed at increased risk by study participation.

Sites / Locations

  • University of Rochester Medical Center NICU

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Glycerin Suppository

No Glycerin Suppository

Arm Description

Based on our institution's protocol, infant will receive a glycerin shave within one hour of initiation of phototherapy and then every eight hours while under phototherapy. Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups: Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs. Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.

Infants will receive no scheduled glycerin suppositories, while under phototherapy (unless otherwise directed by attending physician). Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups: Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs. Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.

Outcomes

Primary Outcome Measures

Total Number of Hours of Required Phototherapy

Secondary Outcome Measures

Number of Episodes of Repeat Phototherapy
Bilirubin levels are checked at regular intervals after phototherapy is discontinued to make sure levels are safe. Depending on rate of rise and predetermined "unsafe" bilirubin level, phototherapy may be restarted.
Peak Total Serum Bilirubin Level
Bilirubin levels were checked every 12 hours while the infant was under phototherapy. A bilirubin level was then to be checked at least twice, 8-12 hours or longer apart, following discontinuation of phototherapy.
Rate of Decline in Bilirubin Levels (mg/dL/hr)
Absolute change over time from peak to first discontinuation of phototherapy lights
Length of Initial Round of Phototherapy
time start to time finally off phototherapy, including any breaks during which they were off

Full Information

First Posted
October 8, 2012
Last Updated
November 4, 2015
Sponsor
University of Rochester
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1. Study Identification

Unique Protocol Identification Number
NCT01746511
Brief Title
Glycerin Suppositories to Reduce Jaundice in Premature Infants
Official Title
The Use of Glycerin Suppositories to Reduce Hyperbilirubinemia in Premature Infants Requiring Phototherapy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Hyperbilirubinemia, Neonatal Hyperbilirubinemia, Prematurity
Keywords
glycerin suppositories, glycerin shaves, neonatal hyperbilirubinemia, idiopathic hyperbilirubinemia, jaundice, neonatal jaundice, prematurity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glycerin Suppository
Arm Type
Active Comparator
Arm Description
Based on our institution's protocol, infant will receive a glycerin shave within one hour of initiation of phototherapy and then every eight hours while under phototherapy. Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups: Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs. Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.
Arm Title
No Glycerin Suppository
Arm Type
Experimental
Arm Description
Infants will receive no scheduled glycerin suppositories, while under phototherapy (unless otherwise directed by attending physician). Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups: Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs. Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.
Intervention Type
Procedure
Intervention Name(s)
Phototherapy
Other Intervention Name(s)
Bili light
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
glycerin suppository
Other Intervention Name(s)
glycerin shave
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total Number of Hours of Required Phototherapy
Time Frame
from time of enrollment to time of discharge, for a maximum of 10 weeks
Secondary Outcome Measure Information:
Title
Number of Episodes of Repeat Phototherapy
Description
Bilirubin levels are checked at regular intervals after phototherapy is discontinued to make sure levels are safe. Depending on rate of rise and predetermined "unsafe" bilirubin level, phototherapy may be restarted.
Time Frame
from time of enrollment to time of discharge, for a maximum of 10 weeks
Title
Peak Total Serum Bilirubin Level
Description
Bilirubin levels were checked every 12 hours while the infant was under phototherapy. A bilirubin level was then to be checked at least twice, 8-12 hours or longer apart, following discontinuation of phototherapy.
Time Frame
from time of enrollment to time of discharge every 12 hours while under phototherapy, for a maximum of 10 weeks
Title
Rate of Decline in Bilirubin Levels (mg/dL/hr)
Description
Absolute change over time from peak to first discontinuation of phototherapy lights
Time Frame
from time of enrollment to time of discharge, for a maximum of 10 weeks
Title
Length of Initial Round of Phototherapy
Description
time start to time finally off phototherapy, including any breaks during which they were off
Time Frame
from time of enrollment to time of discharge, for a maximum of 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Weeks
Maximum Age & Unit of Time
35 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Baby born between 30 to 34 6/7 weeks gestational age (GA) at birth and admitted to NICU Baby with physiologic hyperbilirubinemia requiring phototherapy by current NICU criteria. Parental permission. Exclusion Criteria: Babies less than 30 weeks GA or greater than 34 6/7 weeks GA Non-physiologic hyperbilirubinemia: (1) positive Coombs test and (2) hematocrit < 5th percentile for GA (see Jopling J, Henry E, Wiedmeier SE, Christensen RD, Reference. Ranges for Hematocrit and Blood Hemoglobin Concentration During the Neonatal Period: Data From a Multihospital Health Care System. Pediatrics 2009; 123(2):e333 -e337.) and (3) ABO or Rh incompatibility. Any infant with bilirubin level within 2 mg/dL of exchange transfusion. Any infant who has phototherapy started prior to reaching light level (prophylactic) Baby with any GI abnormalities such as NEC, intestinal perforation, gastroschisis, omphalocele, malrotation and or volvulus, duodenal atresia, intestinal strictures/adhesions, imperforate anus. Any infant begun on triple or greater phototherapy at time of initiation of treatment. Any infant judged by the attending physician to be placed at increased risk by study participation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meggan Butler-O'Hara, RN, MSN, PNP
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester Medical Center NICU
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Maisels MJ. Jaundice. In: Avery GB, Fletcher MA, MacDonald MG, eds. Neonatology: Pathophysiology and Management of the Newborn. Philadelphia: Lippincott Williams and Wilkins; 1999:765-819.
Results Reference
background
PubMed Identifier
4177180
Citation
Rosta J, Makoi Z, Kertesz A. Delayed meconium passage and hyperbilirubinaemia. Lancet. 1968 Nov 23;2(7578):1138. doi: 10.1016/s0140-6736(68)91603-6. No abstract available.
Results Reference
background
PubMed Identifier
5771508
Citation
Porto SO. Jaundice in congenital malrotation of the intestine. Am J Dis Child. 1969 Jun;117(6):684-8. doi: 10.1001/archpedi.1969.02100030686011. No abstract available.
Results Reference
background
PubMed Identifier
98182
Citation
Jirsova V, Janovsky M. Hyperbilirubinemia connected with parenteral administration of higher amounts of fluids in premature infants. Biol Neonate. 1978;33(3-4):132-4. doi: 10.1159/000241062.
Results Reference
background
PubMed Identifier
4056981
Citation
De Carvalho M, Robertson S, Klaus M. Fecal bilirubin excretion and serum bilirubin concentrations in breast-fed and bottle-fed infants. J Pediatr. 1985 Nov;107(5):786-90. doi: 10.1016/s0022-3476(85)80418-2.
Results Reference
background
PubMed Identifier
3646618
Citation
Boyer DB, Vidyasagar D. Serum indirect bilirubin levels and meconium passage in early fed normal newborns. Nurs Res. 1987 May-Jun;36(3):174-8.
Results Reference
background
PubMed Identifier
16118723
Citation
Bader D, Yanir Y, Kugelman A, Wilhelm-Kafil M, Riskin A. Induction of early meconium evacuation: is it effective in reducing the level of neonatal hyperbilirubinemia? Am J Perinatol. 2005 Aug;22(6):329-33. doi: 10.1055/s-2005-871529.
Results Reference
background
PubMed Identifier
6858980
Citation
Weisman LE, Merenstein GB, Digirol M, Collins J, Frank G, Hudgins C. The effect of early meconium evacuation on early-onset hyperbilirubinemia. Am J Dis Child. 1983 Jul;137(7):666-8. doi: 10.1001/archpedi.1983.02140330050013.
Results Reference
background
PubMed Identifier
7575822
Citation
Chen JY, Ling UP, Chen JH. Early meconium evacuation: effect on neonatal hyperbilirubinemia. Am J Perinatol. 1995 Jul;12(4):232-4. doi: 10.1055/s-2007-994460.
Results Reference
background
Citation
Amin, S. (2011). Personal communication.
Results Reference
background
PubMed Identifier
19171584
Citation
Jopling J, Henry E, Wiedmeier SE, Christensen RD. Reference ranges for hematocrit and blood hemoglobin concentration during the neonatal period: data from a multihospital health care system. Pediatrics. 2009 Feb;123(2):e333-7. doi: 10.1542/peds.2008-2654.
Results Reference
background

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Glycerin Suppositories to Reduce Jaundice in Premature Infants

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