Parenteral Nutrition Cycling for Prevention of Cholestatic Syndrome in Newborn

Not Applicable

Recruiting

• Conditions: Cholestasis in Newborn
• Interventions: Other: Parenteral nutrition cycling

• Registration Number: NCT06366880
• Lead Sponsor: Hospital Pediátrico de Sinaloa

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.

Detailed Description

Methods/design:

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.

Primary outcomes Incidence of colestasis on Day 28 of admission.

Secondary outcomes are total plasma bilirrubine profiles, the incidence of hypoglycemia, hospital-acquired infections, length of hospital/NICU stay, in-hospital all-cause mortality, weight, height and head circumference.

Discussion: This RCT will examine the effects of NPTC versus late PNT in term and late preterm infants by comparing key biochemical and clinical outcomes and has the potential to identify underlying pathways for beneficial or harmful effects related to both treatments.

Trial registration: 2022.HPS.DI.434 (3rd March 2024)

Keywords: Parenteral nutrition cycling, Incidence of colestasis, incidence of hypoglycaemia, hospital-acquired infections, Randomised controlled trial.

Study Timeline

• Study Start: 2024-03-11
• Study First Submitted: 2024-03-11
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-10
• Last Update Submitted: 2024-04-10
• Study First Posted: 2024-04-16
• Last Update Posted: 2024-04-16
• Primary Completion: 2024-12-15
• Study Completion: 2025-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Parenteral nutrition cycling	Parenteral nutrition cycling	-

Primary Outcome Measures

Name	Time	Method
Incidence of cholestasis on Day 28 of admission.	Day 1 to 28	Proportion of cholestasis

Secondary Outcome Measures

Name	Time	Method
the incidence of hypoglycaemia	Day 1 to 28	mg/dl
are total plasma bilirrubine profiles	Day 1 to 28	mg/dl

Trial Locations

Locations (1)

Hospital Pediatrico de Sinaloa; 🇲🇽 Culiacán, Sinaloa, Mexico