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| Name | Class |
|---|---|
| Baxter Healthcare Corporation | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| More concentrated parenteral nutrition solution | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Primary outcome is weight Standard Deviation Score (SDS) | 28 days |
| 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. |
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Inclusion Criteria:
The infants were divided into two groups:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Umeå University Hospital | Umeå | SE-90185 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35726971 | Derived | 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. |
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Blood samples
|
| 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 |
| ID | Term |
|---|---|
| D007228 | Infant Nutrition Disorders |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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