Parenteral Nutrition Cycling for Prevention of Cholestatic Syndrome in Newborn

Hospital Pediátrico de Sinaloa

Status: Enrolling

Conditions: Cholestasis in Newborn

Treatments: Other: Parenteral nutrition cycling

Study type: Interventional

Funder types: Other

Identifiers

NCT06366880

2022.HPS.DI.434

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 estimated patients

Sex: All

Ages: 1 hour to 28 days old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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66 participants in 2 patient groups

Parenteral nutrition cycling

Experimental group

Treatment:

Other: Parenteral nutrition cycling

Continuous parenteral nutrition

No Intervention group