Outcome of Very Preterm Infants With Glucose Level Disturbances

August 28, 2023 updated by: Ivona Butorac Ahel, University Hospital Rijeka

Neurodevelopmental Outcome of Very Preterm Infants With Glucose Level Disturbances at the Age of Two

The hypothesis of this prospective, cohort study is that hyperglycemia, hypoglycemia and unstable glucose levels in the first seven days of life in infants born very preterm and at very low birth weights can harm long-term neurodevelopment. The objective of the study is to investigate the relationship between early neonatal glycemia, neonatal characteristics, and developmental outcomes in preterm infants. All infants born before 32. gestational week or below 1500 g admitted to the neonatal intensive care unit will be included in the study. According to the glucose values, the infants will be divided into the normoglycemic group and the group with disturbed glucose concentration. In the corrected age of two neurodevelopmental outcome will be assessed and categorized as normal, mild, moderate or severe impairment. Since the results of published studies about the effects of asymptomatic neonatal hypoglycemia and hyperglycemia on neurodevelopment are inconsistent, the correlation between early disturbances in glucose levels and neurodevelopmental outcome will be assessed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All infants born before 32 weeks of gestation or weighing <1500 g and admitted to the Neonatal intensive care unit of the University Hospital Center Rijeka will be included into the study. The investigators will collect data from the neonatal period, including: gestational age, sex, birth weight, Apgar score at 1 and 5 minutes, socioeconomic status and Clinical Risk Index for Babies scoring system (CRIB II). Blood glucose levels will be measured at 3rd, 12th, and 18th hour after birth on the first day of life, and from the 2nd to the 7th day of life blood glucose levels will be measured once a day. According to the blood glucose concentrations infants will be divided into normoglycemic group and group with disturbed glucose concentration. The relationship between glycemia category and 2-year outcomes will be investigated. In the corrected age of two years neurodevelopmental outcome will be assessed. Certified psychologists will assess cognitive, motor and language development with the Bayley Scales of Infant and Toddler Development (Bayley III). Bayley III scales are standardized to a mean (SD) score of 100. Pediatric neurologists or pediatrics will examine the children and will estimate the neuromotor function. Cognitive, motor and language development were considered normal if the composite score on the respective Bayley-III score was ≥mean -1SD; mildly impaired if the score was < -1 SD and ≥ -2 SD; moderately impaired if the score was <-2 SD and ≥3 SD; and severely impaired if the score was < mean -3SD.

Cerebral palsy (CP) was evaluated according to the European Cerebral Palsy Network definition. The severity of CP was classified as mild in children who were able to walk without an aid, moderate in children able to walk with an aid, and severe in children who were unable to walk even with an aid.

Children unable to fixate and follow a light with either eye were considered bilaterally blind. Children registered at low-vision centers without blindness were recorded as having moderate visual impairment. Severe auditory impairment was defined as hearing loss that could not be corrected with a hearing aid and moderate auditory impairment was defined as hearing loss corrected with a hearing aid.

The overall outcome was categorized as normal, mild, moderate or severe impairment. Mild impairment was defined as scores between -1and -2 standard deviations from the mean of any of the Bayley-III scales or mild CP. Moderate impairment was defined as scores between -2and -3 standard deviations from the mean of any of the Bayley-III scales, moderate CP, or moderate visual or hearing impairment. Severe impairment was defined as scores between < mean -3 standard deviations of any of the Bayley-III scales, severe CP, or bilateral blindness or deafness.

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Rijeka, Croatia, 51000
        • University Hospital Center Rijeka

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 2 years (Child)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

We will include all infants born before 32 of weeks gestation or weighing below 1500 g and admitted to the Neonatal intensive care unit (NICU) of University Hospital Center Rijeka. Blood glucose concentrations will be measured and recorded from birth until the end of postnatal day 7. Based on the values of glucose concentrations, infantsi will be categorized as normoglycemic, hypoglycemic, hyperglycemic and unstable. At the age between 22,5 and 26,5 months of corrected age assessment by neurologist and psychologist will be performed.

This study is approved by Ethics Committee of University Hospital Center Rijeka and by the Ethics Committee of University of Rijeka - Faculty of Medicine.

Description

Inclusion Criteria:

  • infants born weighing <1500 g or at <32 weeks of gestation

Exclusion Criteria:

  • infants with significant congenital abnormalities
  • infants died before day 7
  • infants whose mothers suffer from type 1, type 2 diabetes mellitus or gestational diabetes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Normoglycemic group

The infant will enter this group if a single blood glucose concentration is between 2.1 and 2.5 mmol/l (38-45 mg/dL), or a single blood glucose concentration is between 8.6 - 10 mmol/l (155-180 mg/dL) with all other measures between 2.6 and 8.5 mmol/l (47-153 mg/dL).

To all premature infants intravenous 10% dextrose at 60-90 mL/kg/day will be started as soon as possible after birth.
Drug: 10% dextrose
After birth the intravenous 10% dextrose at 60-90 ml/kg/day will be started as soon as possible
Other Names:
  • There is no other intervention names
Group with impaired glucose

The infant can be hypoglycemic, hyperglycemic or unstable. The infant will be hypoglycemic if blood glucose concentration is ≤2,5 mmol/l (45 mg/dL) on ≥2 measures >1 hour apart, or any blood glucose concentration is≤2,0 mmol/l (36 mg/dL). Hypoglycemia will be treated with intravenous bolus of 10% dextrose.

The infant will be hyperglycemic if blood glucose concentration is ≥8,6 mmol/l (155 mg/dL) on ≥2 measures >1 hour apart, or any blood glucose concentration ≥10,1 mmol/l (182 mg/dL). Hyperglycemia will be managed by reducing the glucose infusion rate or initiation of an insulin infusion.

The infant will be unstable if at least 1 blood glucose concentration is ≤2,5 mmol/l (45 mg/dL) and ≥1 blood glucose concentration is ≥8,6 mmol/l (155 mg/dL).
Drug: bolus of dextrose, reducing the glucose infusion, insulin

Hypoglycemia will be treated with 2 mL/kg to 3 mL/kg (200-300 mg/kg) intravenous bolus of 10% dextrose.

Hyperglycemia will be managed by reducing the glucose infusion rate or initiation of an insulin infusion.

Other Names:
  • There is no other intervention names

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurodevelopmental outcome of each group at the age of two performed using Bayley Scales of Infant and Toddler Development Bayley III
Time Frame: up to 27 months
Mild impairment was defined as scores between -1and -2 standard deviations (70 - 85) from the mean of any of the Bayley-III scales or mild CP. Moderate impairment was defined as scores between -2and -3 standard deviations (55 - 70) from the mean of any of the Bayley-III scales, moderate CP, or moderate visual or hearing impairment. Severe impairment was defined as scores between < mean -3 standard deviations (<55) of any of the Bayley-III scales, severe CP, or bilateral blindness or deafness.
up to 27 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Rijeka

Investigators

  • Principal Investigator: Ivona Butorac Ahel, MD, MS, University Hospital Center Rijeka, 51 000 Rijeka, Croatia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

April 22, 2018

First Submitted That Met QC Criteria

May 17, 2018

First Posted (Actual)

May 21, 2018

Study Record Updates

Last Update Posted (Actual)

August 29, 2023

Last Update Submitted That Met QC Criteria

August 28, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • istrazivanje01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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