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

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ClinicalTrials.gov Identifier: NCT04085484
Recruitment Status : Active, not recruiting
First Posted : September 11, 2019
Last Update Posted : September 12, 2019
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Magnus Domellöf, Umeå University

Brief 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.

Condition or disease Intervention/treatment
Nutrition Disorder, Infant 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.


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Study Type : Observational
Actual Enrollment : 134 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Effects of Two Different Parenteral Nutrition Regimes on Nutrient Intakes, Growth and Plasma Electrolytes in Very Low Birth Weight Infants
Actual Study Start Date : January 8, 2013
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : July 30, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Weight [ Time Frame: 28 days ]
    Primary outcome is weight Standard Deviation Score (SDS)


Secondary Outcome Measures :
  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)


Biospecimen Retention:   Samples Without DNA
Blood samples


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04085484


Locations
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Sweden
Umeå University Hospital
Umeå, Sweden, SE-90185
Sponsors and Collaborators
Umeå University
Baxter Healthcare Corporation

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Responsible Party: Magnus Domellöf, Professor, Principal Investigator, Umeå University
ClinicalTrials.gov Identifier: NCT04085484     History of Changes
Other Study ID Numbers: 2011/417-31M
First Posted: September 11, 2019    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Magnus Domellöf, Umeå University:
preterm
Additional relevant MeSH terms:
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Nutrition Disorders
Infant Nutrition Disorders
Birth Weight
Body Weight
Signs and Symptoms
Parenteral Nutrition Solutions
Nutrients
Pharmaceutical Solutions
Growth Substances
Physiological Effects of Drugs