Parenteral Nutrition Cycling for Prevention of Cholestati... | NCT06366880

Studies
Parenteral Nutrition Cycling for Prevention of Cholestatic Syndrome in Newborn

NCT06366880

Sponsor

Hospital Pediátrico de Sinaloa

Status

Unknown status

Last Update Posted

Apr 16, 2024Actual

Enrollment

66Estimated

Phase

Not Applicable

Conditions

Cholestasis in Newborn

Interventions

Parenteral nutrition cycling

Countries

Mexico

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 11, 2024Actual

Primary Completion Date

Dec 15, 2024Estimated

Completion Date

Dec 15, 2025Estimated

First Submitted Date

Mar 11, 2024

First Submission Date that Met QC Criteria

Apr 10, 2024

First Posted Date

Apr 16, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2024

Last Update Posted Date

Apr 16, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Camargo Angulo Ana Karen, Dr., Hospital Pediátrico de SinaloaPrincipal Investigator

Lead Sponsor

Hospital Pediátrico de SinaloaOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

66Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Parenteral nutrition cycling	Experimental		Other: Parenteral nutrition cycling
Continuous parenteral nutrition	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Parenteral nutrition cycling	Other	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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Hour

Maximum Age

28 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ana Karen Camargo Angulo, Dr.	Contact	6681890586	+52	anakarencamargo96@gmail.com
Claudia Gamez, PhD	Contact	6871353192	+52	claudia_ge89@hotmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Pediatrico de Sinaloa	Recruiting	Culiacán	Sinaloa	80200	Mexico