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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Nutrition Disorder, Infant

Intervention / Treatment
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* Dietary Supplement: More concentrated parenteral nutrition solution


Participation Criteria
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Eligibility Criteria
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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: infants born between 1 February 2010 and 18 February 2012, before the concentrated PN regime was implemented (Original PN group: n = 81), and 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.

Ages Eligible for Study
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Minimum Age: 0 Days
Maximum Age: 28 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Infants born between 1 Feb 2010 and 18 Feb 2012<br>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<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preterm