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Impact of Cyclic Prolonged Parenteral Nutrition in Neonates

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


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

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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

Resource links provided by the National Library of Medicine


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



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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02692326


Locations
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Spain
Nelia Navarro patiño
Madrid, Spain, 28007
Sponsors and Collaborators
Hospital General Universitario Gregorio Marañon
Publications:
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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    Key Record Dates
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:
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Cholestasis
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases