Impact of Cyclic Prolonged Parenteral Nutrition in Neonates

Cholestasis in Newborn Clinical Trial

Official title:

DECREASE OF CHOLESTASIS USING CYCLED PARENTERAL NUTRITION IN NEWBORNS REQUIRING PROLONGED PARENTERAL NUTRITION

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02692326
• Other study ID #: 2014-12
• Status: Completed
• Phase: N/A
• First received: December 16, 2015
• Last updated: February 22, 2016
• Start date: August 2010
• Est. completion date: March 2015

Study information

• Verified date: February 2016
• Source: Hospital General Universitario Gregorio Marañon
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 50 Days

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholestasis
• Cholestasis in Newborn

Intervention

Procedure:
• Cyclic parenteral nutrition
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.

Locations

Country	Name	City	State
Spain	Nelia Navarro patiño	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Universitario Gregorio Marañon

Country where clinical trial is conducted

Spain, 

References & 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% 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	No
Secondary	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.	through study completion, an average of 1 year	No
Secondary	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.	through study completion, an average of 1 year	No
Secondary	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.	through study completion, an average of 1 year	No
Secondary	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.	through study completion, an average of 1 year	No
Secondary	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.	through study completion, an average of 1 year	No
Secondary	Anticholestatic drugs	% of patients with anticholestatic drug in newborns receiving cyclic versus continuous PN in those newborns who need prolonged PN.	through study completion, an average of 1 year	No
Secondary	Anticholestatic drugs	days of duration of treatment with anticholestatic drug in newborns receiving cyclic versus continuous PN in those newborns who need prolonged PN.	through study completion, an average of 1 year	No
Secondary	Adverse effects of the method of cycling used	Percentage of adverse effects, type of adverse affects	through study completion, an average of 1 year	No
Secondary	Mortality	the percentage of patients who died and the cause of death	through study completion, an average of 1 year	No
Secondary	Mortality	The cause of death	through study completion, an average of 1 year	No