Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06366880
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-03-11
Brief Title:
Parenteral Nutrition Cycling for Prevention of Cholestatic Syndrome in Newborn
Sponsor:
Hospital Pediátrico de Sinaloa
Organization:
Hospital Pediátrico de Sinaloa
Study Overview
Official Title:
Parenteral Nutrition Cycling for Prevention of Cholestatic Syndrome in Newborn
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
Methodsdesign
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 hospitalNICU 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 2022HPSDI434 3rd March 2024
Keywords Parenteral nutrition cycling Incidence of colestasis incidence of hypoglycaemia hospital-acquired infections Randomised controlled trial
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 hospitalNICU 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 2022HPSDI434 3rd March 2024
Keywords Parenteral nutrition cycling Incidence of colestasis incidence of hypoglycaemia hospital-acquired infections Randomised controlled trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None