NCT04085484

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2013

Completed
6.7 years until next milestone

First Submitted

Initial submission to the registry

September 3, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 11, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2020

Completed
Last Updated

November 4, 2020

Status Verified

November 1, 2020

Enrollment Period

7.1 years

First QC Date

September 3, 2019

Last Update Submit

November 3, 2020

Conditions

Nutrition Disorder, Infant

Keywords

preterm

Outcome Measures

Primary Outcomes (1)

  • Weight

    Primary outcome is weight Standard Deviation Score (SDS)

    28 days

Secondary Outcomes (3)

  • Length and head circumference

    First 28 days of life

  • Nutrient intakes (macronutrients and electrolytes)

    First 28 days of life

  • Biomarkers of nutrition (electrolytes and glucose)

    First 28 days of life

Study Arms (2)

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

Interventions

More concentrated parenteral nutrition solutionDIETARY_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.

Infants born between 19 Feb 2012 and 30 Sep 2013

Eligibility Criteria

Age0 Days - 28 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Umeå University Hospital

Umeå, SE-90185, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 35726971DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Infant Nutrition DisordersPremature Birth

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Principal Investigator

Study Record Dates

First Submitted

September 3, 2019

First Posted

September 11, 2019

Study Start

January 8, 2013

Primary Completion

February 28, 2020

Study Completion

November 3, 2020

Last Updated

November 4, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)