Outcome of Very Preterm Infants With Glucose Level Disturbances

NCT03530189 | Completed

• 1 other identifier: istrazivanje01
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Hyperglycemia;; Hypoglycemia;; Neurodevelopment;; Prematurity

Outcome Measures

Primary Outcomes (1)

• Neurodevelopmental outcome of each group at the age of two performed using Bayley Scales of Infant and Toddler Development Bayley III

  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

Study Arms (2)

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

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

Interventions

10% dextrose DRUG

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

Also known as: There is no other intervention names

Normoglycemic group

bolus of dextrose, reducing the glucose infusion, insulin DRUG

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.

Also known as: There is no other intervention names

Group with impaired glucose

Eligibility Criteria

• Age: 24 Weeks - 27 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Rijeka: lead

Study Sites (1)

University Hospital Center Rijeka

Rijeka, 51000, Croatia

Location

Related Publications (9)

• Tottman AC, Alsweiler JM, Bloomfield FH, Gamble G, Jiang Y, Leung M, Poppe T, Thompson B, Wouldes TA, Harding JE; PIANO Study Group. Long-Term Outcomes of Hyperglycemic Preterm Infants Randomized to Tight Glycemic Control. J Pediatr. 2018 Feb;193:68-75.e1. doi: 10.1016/j.jpeds.2017.09.081. Epub 2017 Dec 1.

  PMID: 29198539 BACKGROUND

• Sinclair JC, Bottino M, Cowett RM. Interventions for prevention of neonatal hyperglycemia in very low birth weight infants. Cochrane Database Syst Rev. 2011 Oct 5;(10):CD007615. doi: 10.1002/14651858.CD007615.pub3.

  PMID: 21975772 BACKGROUND

• Mitanchez D. Glucose regulation in preterm newborn infants. Horm Res. 2007;68(6):265-71. doi: 10.1159/000104174. Epub 2007 Jun 20.

  PMID: 17587854 BACKGROUND

• Goode RH, Rettiganti M, Li J, Lyle RE, Whiteside-Mansell L, Barrett KW, Casey PH. Developmental Outcomes of Preterm Infants With Neonatal Hypoglycemia. Pediatrics. 2016 Dec;138(6):e20161424. doi: 10.1542/peds.2016-1424. Epub 2016 Nov 4.

  PMID: 27940690 BACKGROUND

• Tin W, Brunskill G, Kelly T, Fritz S. 15-year follow-up of recurrent "hypoglycemia" in preterm infants. Pediatrics. 2012 Dec;130(6):e1497-503. doi: 10.1542/peds.2012-0776. Epub 2012 Nov 5.

  PMID: 23129080 BACKGROUND

• Lucas A, Morley R, Cole TJ. Adverse neurodevelopmental outcome of moderate neonatal hypoglycaemia. BMJ. 1988 Nov 19;297(6659):1304-8. doi: 10.1136/bmj.297.6659.1304.

  PMID: 2462455 BACKGROUND

• Hey E. Hyperglycaemia and the very preterm baby. Semin Fetal Neonatal Med. 2005 Aug;10(4):377-87. doi: 10.1016/j.siny.2005.04.008.

  PMID: 15927546 BACKGROUND

• Decaro MH, Vain NE. Hyperglycaemia in preterm neonates: what to know, what to do. Early Hum Dev. 2011 Mar;87 Suppl 1:S19-22. doi: 10.1016/j.earlhumdev.2011.01.005. Epub 2011 Jan 26.

  PMID: 21276670 BACKGROUND

• Surveillance of Cerebral Palsy in Europe. Surveillance of cerebral palsy in Europe: a collaboration of cerebral palsy surveys and registers. Surveillance of Cerebral Palsy in Europe (SCPE). Dev Med Child Neurol. 2000 Dec;42(12):816-24. doi: 10.1017/s0012162200001511.

  PMID: 11132255 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy; Hyperglycemia; Hypoglycemia; Premature Birth

Interventions

Glucose; Insulin

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Ivona Butorac Ahel, MD, MS

  University Hospital Center Rijeka, 51 000 Rijeka, Croatia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ivona Butorac Ahel, MD, MS, principal investigator

Study Record Dates

• First Submitted: April 22, 2018
• First Posted: May 21, 2018
• Study Start: January 1, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: August 29, 2023

Record last verified: 2023-08

Locations

CR (1)