Impact of Cyclic Prolonged Parenteral Nutrition in Neonates

Hospital General Universitario Gregorio Marañon

Status: Completed

Conditions: Cholestasis in Newborn

Treatments: Procedure: Cyclic parenteral nutrition

Study type: Interventional

Funder types: Other

Identifiers

NCT02692326

2014-12 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 10 to 50 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

50 participants in 2 patient groups

Intervention: Cyclic parenteral nutrition Cohort

Experimental group

Description:

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.

Treatment:

Procedure: Cyclic parenteral nutrition

Control: Continuous parenteral nutrition

No Intervention group

Description:

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