Fluid in Neonatal Hyperbilirubinemia

Bilirubinemia Clinical Trial

Official title:

Role of Fluid Supplementation in Neonatal Unconjugated Hyperbilirubinemia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03684499
• Other study ID #: fsnh
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: June 30, 2020

Study information

• Verified date: September 2018
• Source: Assiut University
• Contact: Azza ahmed, professor
• Phone: 01006863277
• Email: azza.eisa[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: June 30, 2020
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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 .

Related Conditions & MeSH terms

• Bilirubinemia
• Hyperbilirubinemia

Intervention

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.
• 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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	decrease of bilirubin level after fluid supplementation	bilirubin level will be measured on admission and after 24 hours and	24 hours
Secondary	phototherapy	reduce duration of phototherapy	24