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Impact of Cyclic Prolonged Parenteral Nutrition in Neonates

Primary Purpose

Cholestasis in Newborn

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Cyclic parenteral nutrition
Sponsored by
Hospital General Universitario Gregorio Marañon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholestasis in Newborn focused on measuring intrahepatic cholestasis, infant newborn, cyclic parenteral nutrition

Eligibility Criteria

10 Days - 50 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • Nelia Navarro patiño

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention: Cyclic parenteral nutrition Cohort

Control: Continuous parenteral nutrition

Arm Description

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.

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

Outcomes

Primary Outcome Measures

% 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.

Secondary Outcome Measures

Incidence of sepsis
The percentage of patients who was diagnosed of sepsis in newborns receiving cyclic versus continuous PN in those newborns who need prolonged PN.
Incidence of catheter related sepsis (CRS)
The percentage of patients who was diagnosed of CRS in newborns receiving cyclic versus continuous PN in those newborns who need prolonged PN.
Mean length of hospital stay
The mean length of hospital stay in newborns receiving cyclic versus continuous PN in those newborns who need prolonged PN.
Nutrition factors to the development of PNAC
total days on enteral nutrition in newborns receiving cyclic versus continuous PN in those newborns who need prolonged PN.
Nutrition factors to the development of PNAC
total days on parenteral nutrition in newborns receiving cyclic versus continuous PN in those newborns who need prolonged PN.
Anticholestatic drugs
% of patients with anticholestatic drug in newborns receiving cyclic versus continuous PN in those newborns who need prolonged PN.
Anticholestatic drugs
days of duration of treatment with anticholestatic drug in newborns receiving cyclic versus continuous PN in those newborns who need prolonged PN.
Adverse effects of the method of cycling used
Percentage of adverse effects, type of adverse affects
Mortality
the percentage of patients who died and the cause of death
Mortality
The cause of death

Full Information

First Posted
December 16, 2015
Last Updated
February 22, 2016
Sponsor
Hospital General Universitario Gregorio Marañon
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1. Study Identification

Unique Protocol Identification Number
NCT02692326
Brief Title
Impact of Cyclic Prolonged Parenteral Nutrition in Neonates
Official Title
DECREASE OF CHOLESTASIS USING CYCLED PARENTERAL NUTRITION IN NEWBORNS REQUIRING PROLONGED PARENTERAL NUTRITION
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital General Universitario Gregorio Marañon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholestasis in Newborn
Keywords
intrahepatic cholestasis, infant newborn, cyclic parenteral nutrition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention: Cyclic parenteral nutrition Cohort
Arm Type
Experimental
Arm Description
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.
Arm Title
Control: Continuous parenteral nutrition
Arm Type
No Intervention
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Cyclic parenteral nutrition
Intervention Description
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.
Primary Outcome Measure Information:
Title
% patients with parenteral nutrition associated cholestasis (PNAC)
Description
The incidence of parenteral nutrition associated cholestasis in newborns receiving cyclic versus continuous PN in those newborns who need prolonged PN.
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Incidence of sepsis
Description
The percentage of patients who was diagnosed of sepsis in newborns receiving cyclic versus continuous PN in those newborns who need prolonged PN.
Time Frame
through study completion, an average of 1 year
Title
Incidence of catheter related sepsis (CRS)
Description
The percentage of patients who was diagnosed of CRS in newborns receiving cyclic versus continuous PN in those newborns who need prolonged PN.
Time Frame
through study completion, an average of 1 year
Title
Mean length of hospital stay
Description
The mean length of hospital stay in newborns receiving cyclic versus continuous PN in those newborns who need prolonged PN.
Time Frame
through study completion, an average of 1 year
Title
Nutrition factors to the development of PNAC
Description
total days on enteral nutrition in newborns receiving cyclic versus continuous PN in those newborns who need prolonged PN.
Time Frame
through study completion, an average of 1 year
Title
Nutrition factors to the development of PNAC
Description
total days on parenteral nutrition in newborns receiving cyclic versus continuous PN in those newborns who need prolonged PN.
Time Frame
through study completion, an average of 1 year
Title
Anticholestatic drugs
Description
% of patients with anticholestatic drug in newborns receiving cyclic versus continuous PN in those newborns who need prolonged PN.
Time Frame
through study completion, an average of 1 year
Title
Anticholestatic drugs
Description
days of duration of treatment with anticholestatic drug in newborns receiving cyclic versus continuous PN in those newborns who need prolonged PN.
Time Frame
through study completion, an average of 1 year
Title
Adverse effects of the method of cycling used
Description
Percentage of adverse effects, type of adverse affects
Time Frame
through study completion, an average of 1 year
Title
Mortality
Description
the percentage of patients who died and the cause of death
Time Frame
through study completion, an average of 1 year
Title
Mortality
Description
The cause of death
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Days
Maximum Age & Unit of Time
50 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Facility Information:
Facility Name
Nelia Navarro patiño
City
Madrid
ZIP/Postal Code
28007
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
10903005
Citation
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.
Results Reference
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Impact of Cyclic Prolonged Parenteral Nutrition in Neonates

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