Risk Factor for Cholestasis in Neonates Receiving TPN(Total Parenteral Nutrition)

NCT ID: NCT05163145

Last Updated: 2022-05-20

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2023-03-02

Brief Summary

The aim of this study is to evaluate the risk factors of PNAC in neonates

Detailed Description

Neonates with prematurity,gastrointestinal dysfunction and very low birth weights are often intolerant to oral feeding.In such infants,the provision of nutrients via parenteral nutrition (PN)becomes necessary for short term survival,as well as long-term health. Wilmore and Dudrick first reported use of parenteral nutrition(PN) for an infant more than 40years ago Soon there after physicians recognized that PN was associated with significant liver changes.In the first reported case of parenteral nutrition-associated conjugated hyperbilirubinemia (PNAC) in a premature infant hepatomegaly was noted on the18thday of fat-free PN and worsened until death on the71st day of life The hyperbilirubinemia manifest in PNAC is thought to occur from impaired hepatic bileflow, an adynamic gallbladder,and an upsurge in release of conjugated bilirubin as an infant matures.Atbirth,preterm neonates havereduced activity of the uridine diphosphate glucuronosyl transferase1A1 liver enzyme(UDPGT)that catalyzes conjugation of bilirubin As the infant develops,UDPGT becomes more functional, increasing hepatocyte efficiency for conjugation.Thus,in combination with cholestasis,and neonatal intestinal absorption of unconjugated bilirubin,more conjugated bilirubin is made available to pass from the liver into circulation. Parenteral nutrition associated cholestasis (PNAC) is the most common form of liver damage in neonates while receiving parenteral nutrition(PN).Its prevalence was reported between10%and 60%in NICU Cholestasisis acommonly described complication of PN. Its etiology is not fully understood and is thought to be multifactorial Proposed mechanisms included altered bile salt metabolisms secondary to prematurity and toxic effect of PN components on the liver the presence or absence of specific components in parenteral nutrition solutions most certainly contributing to the disease mechanism,and gastrointestinal systems .Aggravating factors such as sepsis and duration of bowel rest have also been described

Conditions

Neonatal Cholestasis; Total Parenteral Nutrition Effect

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Interventions

TPN

early detection of comlications of prolonged TPN on neonatal liver

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Neonates who received PN for ≥14 days

Exclusion Criteria

-

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 28 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mayyada Elsayed Mohamed Hussien

OTHER

Sponsor Role: lead

Responsible Party

Mayyada Elsayed Mohamed Hussien

Mayyada Elsayed Mohamed Hussien

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Mayyada ElsayedMohamed, resident

Role: CONTACT

soadalsayed2@gmail.com

01002686656

Shaimaa MohamedKhala, lecturer

Role: CONTACT

Shaimaakhalaf@aun.edu.eg

01001400503

Other Identifiers

neonates receiveTPN

Identifier Type: -

Identifier Source: org_study_id