Impact of Cyclic Prolonged Parenteral Nutrition in Neonates

Not Applicable

Completed

• Conditions: Cholestasis in Newborn
• Interventions: Procedure: Cyclic parenteral nutrition

• Registration Number: NCT02692326
• Lead Sponsor: Hospital General Universitario Gregorio Marañon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Primary Completion: 2015-01
• Study Completion: 2015-03
• Study First Submitted: 2015-12-16
• Status Verified: 2016-02
• Study First Submitted QC: 2016-02-22
• Last Update Submitted: 2016-02-22
• Study First Posted: 2016-02-26
• Last Update Posted: 2016-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention: Cyclic parenteral nutrition Cohort	Cyclic parenteral nutrition	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.

Primary Outcome Measures

Name	Time	Method
% patients with parenteral nutrition associated cholestasis (PNAC)	through study completion, an average of 1 year	The incidence of parenteral nutrition associated cholestasis in newborns receiving cyclic versus continuous PN in those newborns who need prolonged PN.

Secondary Outcome Measures

Name	Time	Method
Incidence of catheter related sepsis (CRS)	through study completion, an average of 1 year	The percentage of patients who was diagnosed of CRS in newborns receiving cyclic versus continuous PN in those newborns who need prolonged PN.
Incidence of sepsis	through study completion, an average of 1 year	The percentage of patients who was diagnosed of sepsis in newborns receiving cyclic versus continuous PN in those newborns who need prolonged PN.
Nutrition factors to the development of PNAC	through study completion, an average of 1 year	total days on parenteral nutrition in newborns receiving cyclic versus continuous PN in those newborns who need prolonged PN.
Anticholestatic drugs	through study completion, an average of 1 year	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	through study completion, an average of 1 year	Percentage of adverse effects, type of adverse affects
Mortality	through study completion, an average of 1 year	The cause of death
Mean length of hospital stay	through study completion, an average of 1 year	The mean length of hospital stay in newborns receiving cyclic versus continuous PN in those newborns who need prolonged PN.

Trial Locations

Locations (1)

Nelia Navarro patiño; 🇪🇸 Madrid, Spain