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NCT Number: NCT02692326

Impact of Cyclic Prolonged Parenteral Nutrition in Neonates

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.

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Key information

Conditions

Cholestasis in Newborn Bile Duct Diseases Biliary Tract Diseases Cholestasis Cholestasis, Intrahepatic Digestive System Diseases Liver Diseases

Age range

10 day–50 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nelia Navarro patiño

Madrid, 28007, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cyclic parenteral nutrition

Procedure

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospital General Universitario Gregorio Marañon

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Feb 26, 2016
Registry last updated
Feb 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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