Impact of Cyclic Prolonged Parenteral Nutrition in Neonates

NCT02692326 | Completed

• 1 other identifier: 2014-12
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of our study is to compare the incidence of PNAC in newborns receiving cyclic versus continuous parenteral nutrition (PN) in those newborns who need prolonged PN. The secondary aims are to compare incidence of sepsis and catheter related sepsis, mean length of hospital stay, mortality, nutritional status at two years of chronological age and predisposing factors to the development of parenteral nutrition associated cholestasis (PNAC) between the two groups, and to evaluate the adverse effects of the method of cycling used. This was a single-center, prospective randomized not blinded study was conducted in a level 3 neonatal intensive care unit from July 2010 to January 2015. Infants with hemodynamic instability until a stable situation, congenital hepatic disease, preterm infants with diagnosis of respiratory distress syndrome or persistent ductus arteriosus and lack of authorization from the parents or guardians were excluded.

Conditions

Cholestasis in Newborn

Keywords

intrahepatic cholestasis; infant newborn; cyclic parenteral nutrition

Outcome Measures

Primary Outcomes (1)

• % patients with parenteral nutrition associated cholestasis (PNAC)

  The incidence of parenteral nutrition associated cholestasis in newborns receiving cyclic versus continuous PN in those newborns who need prolonged PN.

  through study completion, an average of 1 year

Secondary Outcomes (10)

• Incidence of sepsis

  through study completion, an average of 1 year

• Incidence of catheter related sepsis (CRS)

  through study completion, an average of 1 year

• Mean length of hospital stay

  through study completion, an average of 1 year

• Nutrition factors to the development of PNAC

  through study completion, an average of 1 year

• Nutrition factors to the development of PNAC

  through study completion, an average of 1 year

Study Arms (2)

Intervention: Cyclic parenteral nutrition Cohort

EXPERIMENTAL

All newborn who were included in the study to receive cyclic parenteral nutrition (within 24 hours). The parenteral nutrition was stopped for one hour the first day until 4 hours in preterm infants and 6 hours in term neonates.

Procedure: Cyclic parenteral nutrition

Control: Continuous parenteral nutrition

NO INTERVENTION

All newborn who were included in the study to receive continuous parenteral nutrition (24 hours). The parenteral nutrition was given by a central line in 24 hours with a basal flow

Interventions

Cyclic parenteral nutrition PROCEDURE

Cyclic parenteral nutrition was provided according to a method described by Longhurst et al. Patients were initially cycled of PN for 1 hour per day with increased rate of 1 hour with a maximum time out of PN of 4 hours for preterm babies \< 37 weeks GA and 6 hours for term newborns. Glucose was monitored at half the time without PN to detect the hypoglycemia.

Intervention: Cyclic parenteral nutrition Cohort

Eligibility Criteria

• Age: 10 Days - 50 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Newborns who needed long-term PN for more than ten days and were diagnosed with a pathology that makes likely the need to extend it.

You may not qualify if:

• Infants with hemodynamic instability until a stable situation, congenital hepatic disease, preterm infants with diagnosis of respiratory distress syndrome or persistent ductus arteriosus and lack of authorization from the parents or guardians

Sponsors & Collaborators

• Hospital General Universitario Gregorio Marañon: lead

Study Sites (1)

Nelia Navarro patiño

Madrid, Madrid, 28007, Spain

Location

Related Publications (1)

• Angelico M, Della Guardia P. Review article: hepatobiliary complications associated with total parenteral nutrition. Aliment Pharmacol Ther. 2000 May;14 Suppl 2:54-7. doi: 10.1046/j.1365-2036.2000.014s2054.x.

  PMID: 10903005 BACKGROUND

MeSH Terms

Conditions

Cholestasis, Intrahepatic

Condition Hierarchy (Ancestors)

Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 16, 2015
• First Posted: February 26, 2016
• Study Start: August 1, 2010
• Primary Completion: January 1, 2015
• Study Completion: March 1, 2015
• Last Updated: February 26, 2016

Record last verified: 2016-02

Locations

ES (1)