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Fluid in Neonatal Hyperbilirubinemia

NCT03684499 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-09-25

No results posted yet for this study

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.

Conditions

  • Bilirubinemia

Interventions

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

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)

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Principal Investigators

  • Yasmeen Hasaneen · Assiut University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Days
Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-01
Primary Completion
2019-11-30
Completion
2020-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03684499 on ClinicalTrials.gov