Impact of Cyclic Prolonged Parenteral Nutrition in Neonates

• ClinicalTrials.gov Identifier: NCT02692326
• Recruitment Status: Completed
• First Posted: February 26, 2016
• Last Update Posted: February 26, 2016
• Sponsor: Hospital General Universitario Gregorio Marañon
• Information provided by (Responsible Party): Manuel Sanchez Luna, Hospital General Universitario Gregorio Marañon

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.

Condition or disease	Intervention/treatment	Phase
Cholestasis in Newborn	Procedure: Cyclic parenteral nutrition	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: DECREASE OF CHOLESTASIS USING CYCLED PARENTERAL NUTRITION IN NEWBORNS REQUIRING PROLONGED PARENTERAL NUTRITION
• Study Start Date: August 2010
• Actual Primary Completion Date: January 2015
• Actual Study Completion Date: March 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intervention: Cyclic parenteral nutrition Cohort; 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; 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.
No Intervention: Control: Continuous parenteral nutrition; 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

Outcome Measures

Primary Outcome Measures :

1. % patients with parenteral nutrition associated cholestasis (PNAC) [ Time Frame: 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 :

1. Incidence of sepsis [ Time Frame: 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.
2. Incidence of catheter related sepsis (CRS) [ Time Frame: 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.
3. Mean length of hospital stay [ Time Frame: 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.
4. Nutrition factors to the development of PNAC [ Time Frame: through study completion, an average of 1 year ]
   total days on enteral nutrition in newborns receiving cyclic versus continuous PN in those newborns who need prolonged PN.
5. Nutrition factors to the development of PNAC [ Time Frame: 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.
6. Anticholestatic drugs [ Time Frame: through study completion, an average of 1 year ]
   % of patients with anticholestatic drug in newborns receiving cyclic versus continuous PN in those newborns who need prolonged PN.
7. Anticholestatic drugs [ Time Frame: 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.
8. Adverse effects of the method of cycling used [ Time Frame: through study completion, an average of 1 year ]
   Percentage of adverse effects, type of adverse affects
9. Mortality [ Time Frame: through study completion, an average of 1 year ]
   the percentage of patients who died and the cause of death
10. Mortality [ Time Frame: through study completion, an average of 1 year ]
    The cause of death

Eligibility Criteria

• Ages Eligible for Study: up to 50 Days (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Spain

Nelia Navarro patiño

Madrid, Spain, 28007

Sponsors and Collaborators

Hospital General Universitario Gregorio Marañon

More Information

Publications:

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.

• Responsible Party: Manuel Sanchez Luna, Clinical Professor, Hospital General Universitario Gregorio Marañon
• ClinicalTrials.gov Identifier: NCT02692326
• Other Study ID Numbers: 2014-12
• First Posted: February 26, 2016
• Last Update Posted: February 26, 2016
• Last Verified: February 2016

Keywords provided by Manuel Sanchez Luna, Hospital General Universitario Gregorio Marañon:

intrahepatic cholestasis; infant newborn; cyclic parenteral nutrition

Additional relevant MeSH terms:

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