Clinical trial NCT06366880: Parenteral Nutrition Cycling for Prevention of Cholestatic Syndrome in Newborn
Official title: Parenteral Nutrition Cycling for Prevention of Cholestatic Syndrome in Newborn
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cholestasis in Newborn
Keywords: Parenteral nutrition cycling
Incidence of colestasis
Incidence of hypoglycemia
Hospital-acquired infections
Randomised controlled trial
Lead sponsor: Hospital Pediátrico de Sinaloa
Sponsor class: OTHER_GOV
First posted: 2024-04-16
Enrollment: 66
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of cholestasis on Day 28 of admission.
timeFrame: Day 1 to 28
Secondary outcomes:
measure: are total plasma bilirrubine profiles
timeFrame: Day 1 to 28
measure: the incidence of hypoglycaemia
timeFrame: Day 1 to 28
Other outcomes:
Locations:
city: Culiacán
country: Mexico
facility: Hospital Pediatrico de Sinaloa
state: Sinaloa
Study officials:
References: