Glucose Disturbances in Premature Infants and Quality of Life

• Conditions: Neonatal Hypoglycemia; Neonatal Hyperglycaemia

• Registration Number: NCT04770636
• Lead Sponsor: Clinical Hospital Center Rijeka

Brief 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

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.

Study Timeline

• Study Start: 2013-08-01
• Primary Completion: 2015-09-30
• Study First Submitted: 2021-02-23
• Study First Submitted QC: 2021-02-23
• Study First Posted: 2021-02-25
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-06
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 150

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.

Exclusion Criteria

All deceased premature children born in the study period.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Comparison of Quality of life in premature infants in the age of 8 months and 7 years	6,5 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.

Trial Locations

Locations (1)

Clinical Hospital Centre; 🇭🇷 Rijeka, Primorsko-goranska County, Croatia