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NCT06366880

Parenteral Nutrition Cycling for Prevention of Cholestatic Syndrome in Newborn

Recruiting now NA Last updated 16 April 2024
What this trial tests

NA trial testing Parenteral nutrition cycling in Cholestasis in Newborn in 66 participants. Currently enrolling.

Timeline
11 March 2024
Primary endpoint
15 December 2024
15 December 2025

Quick facts

Lead sponsorHospital Pediátrico de Sinaloa
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeprevention
Enrollment66
Start date11 March 2024
Primary completion15 December 2024
Estimated completion15 December 2025
Sites1 location across Mexico

Drugs / interventions tested

Conditions studied

Sponsor

Hospital Pediátrico de Sinaloa

Who can join

Adults 1 Hour to 28 Days, any sex, with Cholestasis in Newborn. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: Despite the use of parenteral nutrition cycling (PNC) in neonatal intensive care units (NICU), there is limited evidence regarding the benefits in relation to the nutrición parenteral total (NPT) in term and late preterm infants. The recommendations from the recently published Latin American Society of Gastroenterology, Hepatology and Pediatric Nutrition guidelines are substantially different in this area, and surveys have reported variations in clinical practice. The aim of this randomised controlled trial (RCT) is to evaluate the benefits and risks of PNC AND parenteral nutrition total (NPT) in term and late preterm infants.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06366880.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing