Fluid in Neonatal Hyperbilirubinemia

Role of Fluid Supplementation in Neonatal Unconjugated Hyperbilirubinemia

Hyperbilirubinemia is a common neonatal problem. bilirubin is potentially toxic to central nervous system and can cause serious permanent complication called kernicterus, in which brain stem nuclei and basal ganglia are damaged,resulting in cerebral palsy.In Hyperbiliubinemia,rapid reduction of serum bilirubin level is of utmost importance.

Two commonly used mode of therapy are phototherapy and exchange transfusion. Phototherapy has some side effects such as diarrhea, skin rash, dehydration, overheating, mother-baby bonding disruption.On the other hand, complication of exchange transfusion include infections, emboli,anemia,apnea and hypocalcemia.

while IV fluid supplementationis postulated to decrease bilirubin concentration directly through a reduction of haemoconcentration, increasing enteral feed volume is proposed to decrease bilirubin concentration through reduced enterohepatic circulation via an increased gut peristalsis.

Study Overview

• Status: Unknown
• Conditions: Bilirubinemia
• Intervention / Treatment: Other: fluid supplementation; Other: breast feeding

Detailed Description

Bilirubin encephalopathy or kernicterus Unconjugated bilirubin is lipid soluble and therefore can cross the blood brain barrier .There it can deposit in areas of the brain, with a predilection for deposition in the basal ganglia, auditory pathways, and oculomotor nucleus. This deposition and accompanying damage result in the classical symptoms associated with kernicterus. Hypoxia, acidosis, prematurity, and genetic predispositions all increase the risk for kernicterus.In well term babies risk for kernicterus increases after bilirubin levels cross (20 mg/dL) and it is very high above (30 mg/dL). In preterm babies the threshold for damage from bilirubin could be as low as(20mg/dl). The risk increases with increasing serum levels of unconjugated bilirubin.

Acute bilirubin encephalopathy presents as lethargy, high pitched cry, poor feeding, abnormal tone, opisthotonus, upgaze palsy and seizures. Aggressive treatment at this stage can reduce the damage caused. Chronic bilirubin encephalopathy leads to conditions like choreoathetoid cerebral palsy, high frequency hearing loss, dental dysplasias and oculomotor palsies.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Azza ahmed, professor; Phone Number: 01006863277; Email: azza.eisa@gmail.com
• Study Contact Backup: Name: Mohamed Gamil, lecturer; Phone Number: 01024741834; Email: mohamed.gmail@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 days to 4 weeks (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1 -Ful term ,Body weight (≥2.5kg). 2- total serum bilirubin range(≥18mg/dl to≤25mg/dl). 3-Non -haemolytic type of jaundice. 4-Ratio of conjugated bilirubin :unconjugated bilirubin is 1:5

Exclusion Criteria:

1 - Body weight ≤2.5kg. 2- Evidence of haemolysis. 3- Obvious features of dehydration. 4- Major congenital malformation . 5- Baby received already IV fluid for any reason. 6- Septicemia . 7-GIT functional or organic obstruction .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: study group (1); The subjects will be divided into two equal groups Study group and control group by randomization. The study group will be given IV fluid supplementation with 0.5% normal saline in dextrose 5%for period of 24hours . The volume of supplementation included a presumed deficit of 50 ml/kg (equivalent to mild dehydration), half of daily maintenance fluid for 24 hours in accordance to standard norms and extra 20 ml/kg per day as a phototherapy allowance. In addition, they will continue breastfeeding. The control group will be continued on breast feeding , before the randomization procedure. All the infants will get phototherapy by standard method. Phototherapy will be discontinued when the bilirubin level will be <15 mg/dl.	Other: fluid supplementation; The subjects will be divided into two equal groups Study group and control group by randomization. The study group will be given IV fluid supplementation with 0.5% normal saline in dextrose 5%for period of 24hours . The volume of supplementation included a presumed deficit of 50 ml/kg (equivalent to mild dehydration), half of daily maintenance fluid for 24 hours in accordance to standard norms and extra 20 ml/kg per day as a phototherapy allowance. In addition, they will continue breastfeeding. All the infants will get phototherapy by standard method. Phototherapy will be discontinued when the bilirubin level will be <15 mg/dl.; Other Names: phototherapy; Other: breast feeding; The subjects will be divided into two equal groups Study group and control group by randomization . The control group will be continued on breast feeding , before the randomization procedure. All the infants will get phototherapy by standard method. Phototherapy will be discontinued when the bilirubin level will be <15 mg/dl.(Bandyopadhyay et al, 2017)
No Intervention: control group( 2); The subjects will be divided into two equal groups Study group and control group by randomization. The study group will be given IV fluid supplementation with 0.5% normal saline in dextrose 5%for period of 24hours . The volume of supplementation included a presumed deficit of 50 ml/kg (equivalent to mild dehydration), half of daily maintenance fluid for 24 hours in accordance to standard norms and extra 20 ml/kg per day as a phototherapy allowance. In addition, they will continue breastfeeding. The control group will be continued on breast feeding , before the randomization procedure. All the infants will get phototherapy by standard method. Phototherapy will be discontinued when the bilirubin level will be <15 mg/dl.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
decrease of bilirubin level after fluid supplementation	bilirubin level will be measured on admission and after 24 hours and	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
phototherapy	reduce duration of phototherapy	24

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Yasmeen Hasaneen, Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2018
• Primary Completion (Anticipated): November 30, 2019
• Study Completion (Anticipated): June 30, 2020

Study Registration Dates

• First Submitted: September 20, 2018
• First Submitted That Met QC Criteria: September 22, 2018
• First Posted (Actual): September 25, 2018

Study Record Updates

• Last Update Posted (Actual): September 25, 2018
• Last Update Submitted That Met QC Criteria: September 22, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hyperbilirubinemia
• Other Study ID Numbers: fsnh

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No