Fluid in Neonatal Hyperbilirubinemia

NCT ID: NCT03684499

Last Updated: 2018-09-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2020-06-30

Brief 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.

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.

Conditions

Bilirubinemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

fluid supplementation

Intervention Type: OTHER

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

Intervention Type: OTHER

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)

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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)

Intervention Type: OTHER

Other Intervention Names

phototherapy

Eligibility Criteria

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 .

• Minimum Eligible Age: 3 Days
• Maximum Eligible Age: 28 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Yasmeen Hasaneen Mohamed

role of fluid supplementation in neonatal unconjugated hyperbilirubinemia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yasmeen Hasaneen

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Central Contacts

Azza ahmed, professor

Role: CONTACT

azza.eisa@gmail.com

01006863277

Mohamed Gamil, lecturer

Role: CONTACT

mohamed.gmail@gmail.com

01024741834

Other Identifiers

fsnh

Identifier Type: -

Identifier Source: org_study_id