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Outcome of Very Preterm Infants With Glucose Level Disturbances

NCT03530189 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2023-08-29

No results posted yet for this study

Summary

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.

Conditions

  • Cerebral Palsy Infantile

Interventions

DRUG

10% dextrose

After birth the intravenous 10% dextrose at 60-90 ml/kg/day will be started as soon as possible

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.

Sponsors & Collaborators

  • University Hospital Rijeka

    lead OTHER

Principal Investigators

  • Ivona Butorac Ahel, MD, MS · University Hospital Center Rijeka, 51 000 Rijeka, Croatia

Eligibility

Min Age
24 Weeks
Max Age
27 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Croatia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03530189 on ClinicalTrials.gov