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NCT Number: NCT04085484

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

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.

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Key information

Conditions

Nutrition Disorder, Infant Female Urogenital Diseases and Pregnancy Complications Infant Nutrition Disorders Nutrition Disorders Nutritional and Metabolic Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

0 day–28 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Umeå University Hospital

Umeå, SE-90185, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Weight

    Time frame: 28 days

    Primary outcome is weight Standard Deviation Score (SDS)

Secondary outcomes

  1. Length and head circumference

    Time frame: First 28 days of life

    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.

  2. Nutrient intakes (macronutrients and electrolytes)

    Time frame: First 28 days of life

    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)

  3. Biomarkers of nutrition (electrolytes and glucose)

    Time frame: First 28 days of life

    plasma sodium (mmol/L), potassium (mmol/L), calcium (mmol/L), phosphate (mmol/L), glucose (mmol/L)

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Collaborators

  • Baxter Healthcare Corporation

Registry information

Acronym: PUMPA

Important dates

Study start
2013
Primary completion
2020
Study completion
2020
First posted
Sep 11, 2019
Registry last updated
Nov 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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