Parenteral Nutrition Cycling for Prevention of Cholestatic Syndrome in Newborn

Cholestasis in Newborn Clinical Trial

Official title:

Parenteral Nutrition Cycling for Prevention of Cholestatic Syndrome in Newborn

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06366880
• Other study ID #: 2022.HPS.DI.434
• Status: Recruiting
• Phase: N/A
• Start date: March 11, 2024
• Est. completion date: December 15, 2025

Study information

• Verified date: April 2024
• Source: Hospital Pediátrico de Sinaloa
• Contact: Ana Karen Camargo Angulo, Dr.
• Phone: 6681890586
• Email: anakarencamargo96[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: December 15, 2025
• Est. primary completion date: December 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Hour to 28 Days

Eligibility

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.

Related Conditions & MeSH terms

• Cholestasis
• Cholestasis in Newborn

Intervention

Other:
• 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

Country	Name	City	State
Mexico	Hospital Pediatrico de Sinaloa	Culiacán	Sinaloa

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Pediátrico de Sinaloa

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of cholestasis on Day 28 of admission.	Proportion of cholestasis	Day 1 to 28
Secondary	are total plasma bilirrubine profiles	mg/dl	Day 1 to 28
Secondary	the incidence of hypoglycaemia	mg/dl	Day 1 to 28