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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

134 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-08

Study Completion Date

2020-11-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Nutrition Disorder, Infant

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

No interventions assigned to this group

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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

0 Days

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Magnus Domellöf

Professor, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Umeå University Hospital

Umeå, , Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED

PMID: 35726971 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2011/417-31M

Identifier Type: -

Identifier Source: org_study_id