Impact of Cyclic Prolonged Parenteral Nutrition in Neonates

Study Overview
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Brief Summary
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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.

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

Conditions
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Cholestasis in Newborn

Intervention / Treatment
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* Procedure: Cyclic parenteral nutrition


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Days
Maximum Age: 50 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention: Cyclic parenteral nutrition Cohort<br>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<br>* 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.<br>|
| No Intervention: Control: Continuous parenteral nutrition<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Adverse effects of the method of cycling used | Percentage of adverse effects, type of adverse affects | through study completion, an average of 1 year | 
| Mortality | the percentage of patients who died and the cause of death | through study completion, an average of 1 year | 
| Mortality | The cause of death | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intrahepatic cholestasis, infant newborn, cyclic parenteral nutrition