NCT04770636

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

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2015

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

February 23, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 25, 2021

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

February 6, 2024

Status Verified

February 1, 2024

Enrollment Period

2.2 years

First QC Date

February 23, 2021

Last Update Submit

February 5, 2024

Conditions

Neonatal HypoglycemiaNeonatal Hyperglycaemia

Keywords

Preterm birth, Hypoglycemia, Hyperglycemia, Quality of life

Outcome Measures

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.

    7 years

Secondary Outcomes (1)

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

    6,5 years

Eligibility Criteria

Age6 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Hospital Centre

Rijeka, Primorsko-goranska County, 51000, Croatia

Location

MeSH Terms

Conditions

Premature BirthHypoglycemiaHyperglycemia

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

February 23, 2021

First Posted

February 25, 2021

Study Start

August 1, 2013

Primary Completion

September 30, 2015

Study Completion

July 1, 2024

Last Updated

February 6, 2024

Record last verified: 2024-02

Locations

CR(1)