Parenteral Nutrition Cycling for Prevention of Cholestatic Syndrome in Newborn

NCT06366880 | Recruiting DMC

• 1 other identifier: 2022.HPS.DI.434
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Parenteral nutrition cycling; Incidence of colestasis; Incidence of hypoglycemia; Hospital-acquired infections; Randomised controlled trial

Outcome Measures

Primary Outcomes (1)

• Incidence of cholestasis on Day 28 of admission.

  Proportion of cholestasis

  Day 1 to 28

Secondary Outcomes (2)

• are total plasma bilirrubine profiles

  Day 1 to 28

• the incidence of hypoglycaemia

  Day 1 to 28

Study Arms (2)

Parenteral nutrition cycling

EXPERIMENTAL

Other: Parenteral nutrition cycling

Continuous parenteral nutrition

NO INTERVENTION

Interventions

Parenteral nutrition cycling OTHER

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.

Also known as: Cyclic parenteral nutrition, Cycling parenteral nutrition, Cycle parenteral nutrition

Parenteral nutrition cycling

Eligibility Criteria

• Age: 1 Hour - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Chylothorax
• Intestinal obstruction
• Intestinal malrotation
• Intestinal intussusception
• Gastroschisis
• Intestinal volvulus
• Duodenal atresia
• Enterocolitis
• Sepsis
• Septic shock
• Prolonged fast
• Authorization of the study by parents

You may not qualify if:

• Presence of liver diseases or malformations that cause cholestasis.
• All patients who have received medical treatment for cholestasis are excluded.

Sponsors & Collaborators

• Hospital Pediátrico de Sinaloa: lead

Study Sites (1)

Hospital Pediatrico de Sinaloa

Culiacán, Sinaloa, 80200, Mexico

RECRUITING

Central Study Contacts

Ana Karen Camargo Angulo, Dr.

CONTACT

6681890586; anakarencamargo96@gmail.com

Claudia Gamez, PhD

CONTACT

6871353192; claudia_ge89@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: April 16, 2024
• Study Start: March 11, 2024
• Primary Completion: December 15, 2024
• Study Completion: December 15, 2025
• Last Updated: April 16, 2024

Record last verified: 2024-04

Locations

ME (1)