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Parenteral Nutrition Cycling for Prevention of Cholestatic Syndrome in Newborn
Sponsor: Hospital Pediátrico de Sinaloa
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
Conditions
Interventions
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