NCT04085484

Effects of Two Different Parenteral Nutrition Regimes on Nutrient Intakes, Growth and Plasma Electrolytes in Very Low Birth Weight Infants

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 134 (actual)
• Sponsor: Umeå University · Academic / Other
• Sex: All
• Age: 0 Days – 28 Days
• Healthy volunteers: Not accepted

Summary

A single-center retrospective observational study comparing two cohorts of very low birth weight (VLBW, birth weight \< 1500 grams) infants who received parenteral nutrition (PN) either before or after a concentrated PN regime was implemented into clinical use. Primary outcome is weight SDS at 28 days.

Detailed description

This study is a single-center retrospective observational study comparing two cohorts of very low birth weight (VLBW, birth weight \< 1500 grams) infants who received parenteral nutrition (PN) either before or after a concentrated PN regime was implemented into clinical use. Both PN regimes were based on standardized PN solutions with the possibility to complement with additive nutritional products according to individual assessment by the attending physician. To meet recommended macronutrient intakes, in 2012 a concentrated parenteral nutrition regime was implemented into clinical use at the neonatal intensive care unit in Umeå University hospital, Sweden. However, there is a lack of data on how changes in nutrient intakes affect growth and electrolyte status in preterm infants. Recent studies have demonstrated an increased incidence of hypokalaemia, hypophosphatemia and hypercalcaemia in infants who received enhanced parenteral energy and protein intakes. This study is a single-center retrospective observational study comparing two cohorts of very low birth weight (VLBW, birth weight \< 1500 grams) infants who received parenteral nutrition (PN) either before or after a concentrated PN regime was implemented into clinical use. Both PN regimes were based on standardized PN solutions with the possibility to complement with additive nutritional products according to individual assessment by the attending physician.

Conditions

• Nutrition Disorder, Infant

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	More concentrated parenteral nutrition solution	This study is a single-center retrospective observational study comparing two cohorts of very low birth weight (VLBW, birth weight \< 1500 grams) infants who received parenteral nutrition (PN) either before or after a concentrated PN regime was implemented into clinical use. Both PN regimes were based on standardized PN solutions.

Timeline

• Start date: 2013-01-08
• Primary completion: 2020-02-28
• Completion: 2020-11-03
• First posted: 2019-09-11
• Last updated: 2020-11-04

Locations

1 site across 1 country: Sweden