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

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.

Study Overview

• Status: Completed
• Conditions: Nutrition Disorder, Infant
• Intervention / Treatment: Dietary supplement: More concentrated parenteral nutrition solution

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.

• Study Type: Observational
• Enrollment (Actual): 134

Contacts and Locations

Study Locations

• Sweden
  • Umeå, Sweden, SE-90185
    • Umeå University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 4 weeks (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All infants VLBW infants admitted to the neonatal intensive care unit at Umeå University Hospital, Sweden, within 24 hours after birth and treated there for ≥ 7 days, during 1 February 2010 and 30 September 2013.

Description

Inclusion Criteria:

• All infants VLBW infants admitted to the neonatal intensive care unit at Umeå University Hospital, Sweden, within 24 hours after birth and treated there for ≥ 7 days, during 1 February 2010 and 30 September 2013.

The infants were divided into two groups:

1. infants born between 1 February 2010 and 18 February 2012, before the concentrated PN regime was implemented (Original PN group: n = 81), and
2. infants born between 19 February 2012 and 30 September 2013, after the concentrated PN regime was implemented (Concentrated PN group: n = 53).

Exclusion Criteria:

• Infants with chromosomal or severe congenital anomalies known to affect nutritional intakes and / or growth were excluded from the analyses.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Infants born between 1 Feb 2010 and 18 Feb 2012; Infants born between 1 February 2010 and 18 February 2012, before the concentrated PN regime was implemented (Original PN group: n = 81).
Infants born between 19 Feb 2012 and 30 Sep 2013; Infants born between 19 February 2012 and 30 September 2013, after the concentrated PN regime was implemented (Concentrated PN group: n = 53).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Primary outcome is weight Standard Deviation Score (SDS)	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length and head circumference	Length (SDS score) and head circumference (SDS score) Nutritional intakes: All enteral and parenteral intakes during the first 28 postnatal days. Health outcome: Neonatal morbidities (including respiratory dristress syndrome (RDS), bronchopulmonary dysplasia (BPD), necrotizing enterocolitis (NEC), retinopathy of prematurity (ROP), interaventricular hemorrhage (IVH) mm.) Nutritional biomarkers: Daily measurements of plasma sodium, potassium, calcium and phosphate during the first postnatal week.	First 28 days of life
Nutrient intakes (macronutrients and electrolytes)	Energy intake (kcal/kg), protein intake (g/kg), fat (g/kg), carbohydrates (g/kg), sodium (mg/kg), potassium (mg/kg), calcium (mg/kg), phosphorous (mg/kg)	First 28 days of life
Biomarkers of nutrition (electrolytes and glucose)	plasma sodium (mmol/L), potassium (mmol/L), calcium (mmol/L), phosphate (mmol/L), glucose (mmol/L)	First 28 days of life

Collaborators and Investigators

• Sponsor: Umeå University
• Collaborators: Baxter Healthcare Corporation

Publications and helpful links

General Publications

• Spath C, Sjostrom ES, Domellof M. Higher Parenteral Electrolyte Intakes in Preterm Infants During First Week of Life: Effects on Electrolyte Imbalances. J Pediatr Gastroenterol Nutr. 2022 Sep 1;75(3):e53-e59. doi: 10.1097/MPG.0000000000003532. Epub 2022 Jun 20.

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2013
• Primary Completion (Actual): February 28, 2020
• Study Completion (Actual): November 3, 2020

Study Registration Dates

• First Submitted: September 3, 2019
• First Submitted That Met QC Criteria: September 7, 2019
• First Posted (Actual): September 11, 2019

Study Record Updates

• Last Update Posted (Actual): November 4, 2020
• Last Update Submitted That Met QC Criteria: November 3, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: preterm
• Additional Relevant MeSH Terms: Body Weight; Birth Weight; Nutrition Disorders; Infant Nutrition Disorders; Pharmaceutical Solutions; Parenteral Nutrition Solutions
• Other Study ID Numbers: 2011/417-31M

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No