Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06366880
NA

Parenteral Nutrition Cycling for Prevention of Cholestatic Syndrome in Newborn

Sponsor: Hospital Pediátrico de Sinaloa

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

1 Hour - 28 Days

Study Type

INTERVENTIONAL

Enrollment

66

Start Date

2024-03-11

Completion Date

2025-12-15

Last Updated

2024-04-16

Healthy Volunteers

No

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.

Locations (1)

Hospital Pediatrico de Sinaloa

Culiacán, Sinaloa, Mexico