Glucose Disturbances in Premature Infants and Quality of Life

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 6 to 7 years
• All sexes
• No healthy volunteers
• Child

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.

Trial locations and contacts

1 site in 1 country.

About this study

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

Conditions

Neonatal Hypoglycemia, Neonatal Hyperglycaemia

Keywords

Preterm birth, Hypoglycemia, Hyperglycemia, Quality of life

Medical subject headings

Premature Birth, Hypoglycemia, Hyperglycemia

What is being measured

The primary outcome is the main question the study is designed to answer.

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.

   Measured: 7 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted25 Feb 2021
2. Study start1 Aug 2013
3. Primary completion30 Sep 2015
4. Study completion1 Jul 2024

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Neonatal HypoglycemiaStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.