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Parenteral Nutrition Cycling for Prevention of Cholestatic Syndrome in Newborn

NCT06366880 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2024-04-16

No results posted yet for this study

Summary

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.

Conditions

  • Cholestasis in Newborn

Interventions

OTHER

Parenteral nutrition cycling

This study is a single-centre, non-blinded RCT in the NICU of Pediatric Hospital of Sinaloa, Northwest, Mexico. A total of 66 infants born ≥34 weeks of gestation who have a high likelihood of intolerance to enteral nutrition (EN) for at least 10 days will be randomised to PNC o PNT after informed parental consent. In both groups, EN will be commenced as early as clinically feasible.

Sponsors & Collaborators

  • Hospital Pediátrico de Sinaloa

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Hour
Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-11
Primary Completion
2024-12-15
Completion
2025-12-15

Countries

  • Mexico

Study Locations

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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 NCT06366880 on ClinicalTrials.gov