Parenteral Nutrition Cycling for Prevention of Cholestatic Syndrome in Newborn

April 10, 2024 updated by: Camargo Angulo Ana Karen, Hospital Pediátrico de Sinaloa

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Mexico
    • Sinaloa
      • Culiacán, Sinaloa, Mexico, 80200
        • Recruiting
        • Hospital Pediatrico de Sinaloa
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Parenteral nutrition cycling
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.

Other Names:
  • Cyclic parenteral nutrition
  • Cycling parenteral nutrition
  • Cycle parenteral nutrition
No Intervention: Continuous parenteral nutrition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of cholestasis on Day 28 of admission.
Time Frame: Day 1 to 28
Proportion of cholestasis
Day 1 to 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
are total plasma bilirrubine profiles
Time Frame: Day 1 to 28
mg/dl
Day 1 to 28
the incidence of hypoglycaemia
Time Frame: Day 1 to 28
mg/dl
Day 1 to 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Pediátrico de Sinaloa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2024

Primary Completion (Estimated)

December 15, 2024

Study Completion (Estimated)

December 15, 2025

Study Registration Dates

First Submitted

March 11, 2024

First Submitted That Met QC Criteria

April 10, 2024

First Posted (Actual)

April 16, 2024

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 10, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022.HPS.DI.434

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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