Impact of Cyclic Prolonged Parenteral Nutrition in Neonates

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2015-03-31

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.

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Detailed Description

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Conditions

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Cholestasis in Newborn

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Cyclic parenteral nutrition

Intervention Type 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.

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type PROCEDURE

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

Minimum Eligible Age

10 Days

Maximum Eligible Age

50 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No