Fluid in Neonatal Hyperbilirubinemia

NCT03684499 | Unknown

• 1 other identifier: fsnh
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bilirubinemia

Outcome Measures

Primary Outcomes (1)

• decrease of bilirubin level after fluid supplementation

  bilirubin level will be measured on admission and after 24 hours and

  24 hours

Secondary Outcomes (1)

• phototherapy

  24

Study Arms (2)

study group (1)

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. 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; Other: breast feeding

control group( 2)

NO INTERVENTION

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.

Interventions

fluid supplementation 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.

Also known as: phototherapy

study group (1)

breast feeding 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)

study group (1)

Eligibility Criteria

• Age: 3 Days - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Hyperbilirubinemia

Interventions

Phototherapy; Lactation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Postpartum Period

Study Officials

• Yasmeen Hasaneen

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Azza ahmed, professor

CONTACT

01006863277; azza.eisa@gmail.com

Mohamed Gamil, lecturer

CONTACT

01024741834; mohamed.gmail@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: role of fluid supplementation in neonatal unconjugated hyperbilirubinemia

Study Record Dates

• First Submitted: September 20, 2018
• First Posted: September 25, 2018
• Study Start: December 1, 2018
• Primary Completion: November 30, 2019
• Study Completion: June 30, 2020
• Last Updated: September 25, 2018

Record last verified: 2018-09