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Enrolling by invitationNCT04770636Updated Feb 6, 2024

Glucose Disturbances in Premature Infants and Quality of Life

An observational study in Neonatal Hypoglycemia and Neonatal Hyperglycaemia, sponsored by Clinical Hospital Center Rijeka. Enrolling by invitation at 1 site in Croatia. Open to participants aged 6 Years to 7 Years. Per ClinicalTrials.gov, last updated 2024-02-06.

Sponsored by Clinical Hospital Center Rijeka · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
150
Ages
6 Years to 7 Years
Sex
All
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Study summary

The aim of this study is to investigate the correlation between preterm birth, glucose level in the first two hours of life and health related quality of life in the age of 8 months and 7 years

Read the detailed description

All premature infants treated from August 2013-August 2014 in two Neonatal intensive care units (NICUs) are included in this study. Glucose levels was analyzed two hours after birth. In the age of 8 months parents completed the questionnaire Pediatric Quality of Life - Infant scale. The questionnaire Quality of life for children 5-7 years and for their parents will be offered to them in the next 4 months.

We will investigate if there is a correlation between glucose levels and quality of life in premature infants, and if quality of life changes over years.

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Conditions studied

  • Neonatal Hypoglycemia
  • Neonatal Hyperglycaemia

Keywords

  • Preterm birth, Hypoglycemia, Hyperglycemia, Quality of life
03

In context

Hypoglycemia

640 studies on the registry are indexed under Hypoglycemia; 86 are open to participants now.

This study's planned enrollment of 150 is above the median of 75 across 132 observational studies indexed under Hypoglycemia.

Browse Hypoglycemia studies →

Lead sponsor

Clinical Hospital Center Rijeka is the lead sponsor of 19 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 7 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Participants are all premature infants (born before 37th gestational week) treated in two intensive care units: Neonatal intensive unit cares for inborn premature infants and Pediatric intensive care unit takes care for premature infant born in other hospitals in three counties.

Eligibility criteria

Inclusion Criteria: All premature infants treated in two neonatal intensive units in Clinical Hospital centre Rijeka in the year 2013.- 2014. To reach to final outcome, all questionnaires must be completed.

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Exclusion Criteria: All deceased premature children born in the study period.

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05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
150 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Comparison of glucose levels in prematures after birth and Quality of life in the age of 7 years

    Glucose level was measured two hours after birth in all premature infants. In the age of 8 months and 7 years Quality of life was measured using the questionnaire Paediatric Quality of Life (PedsQL) - Infant scale (6-12 months). The PedsQL Young Child report (5-7 years) and Parent report for Young children (5-7 years) will be offered to one parent/caregiver. In both scales minimum value is zero and maximum is 100; Higher score means better quality of life. The correlation between glucose levels in premature infants and quality of life will be investigated.

    Time frame: 7 years

Secondary outcomes

  1. Comparison of Quality of life in premature infants in the age of 8 months and 7 years

    The questionnaire Paediatric Quality of Life (PedsQL) - Infant scale (6-12 months) was completed by a parent/caregiver of premature infants in the age of 8 months. In the age of 7 years the questionnaire PedsQL Young Child report (5-7 years) and Parent report for Young children (5-7 years) will be offered to parents/caregivers. The quality of life will be compared in these two intervals to investigate the changes in quality of life over time.

    Time frame: 6,5 years

07

Study locations

1 site
  • Clinical Hospital Centre
    Rijeka, Primorsko-goranska County 51000, Croatia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04770636
Lead sponsor
Clinical Hospital Center Rijeka
Responsible party
Kristina Lah Tomulić (MD, PhD, Clinical Hospital Center Rijeka) — Principal investigator
First posted
Feb 25, 2021
Start date
Aug 1, 2013
Primary completion
Sep 30, 2015
Completion
Jul 1, 2024 (estimated)
Last update
Feb 6, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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