Glucose Disturbances in Premature Infants and Quality of Life

Neonatal Hypoglycemia Clinical Trial

Official title:

Glucose Disturbances in the First Day of Life in Preterm Infants and Health-related Quality of Life: is There a Correlation?

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04770636
• Other study ID #: KBC-ped-endo
• Status: Enrolling by invitation
• Start date: August 1, 2013
• Est. completion date: July 1, 2024

Study information

• Verified date: February 2024
• Source: Clinical Hospital Center Rijeka
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 150
• Est. completion date: July 1, 2024
• Est. primary completion date: September 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 7 Years

Eligibility

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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Related Conditions & MeSH terms

• Hyperglycemia
• Hypoglycemia
• Neonatal Hyperglycaemia
• Neonatal Hypoglycemia

Locations

Country	Name	City	State
Croatia	Clinical Hospital Centre	Rijeka	Primorsko-goranska County

Sponsors (1)

Lead Sponsor	Collaborator
Clinical Hospital Center Rijeka

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	7 years
Secondary	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.	6,5 years