Umbilical Cord Glucose

NCT07795047 | Not Yet Recruiting

• 1 other identifier: S-20250083G
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Congenital hyperinsulinism (HI) causes persistent neonatal hypoglycemia that, if untreated, can lead to neurodevelopmental impairments (NDI) such as cognitive delays, cerebral palsy, epilepsy, and blindness. Despite being preventable with early diagnosis and treatment, 30-50% of affected infants still suffer NDI. Transient HI occurs in about 1 in 1,200 births, while persistent forms are rarer. Current screening focuses on high-risk groups but misses many infants with HI, resulting in delayed diagnosis and brain injury. Our pilot research suggests that measuring umbilical cord blood glucose (UCBG), already routinely collected for other purposes, can serve as a timely, non-invasive screening test for HI. Arterial UCBG below 3.5 mmol/L showed excellent accuracy in predicting pathological HI. This project aims to validate UCBG screening for neonatal HI, implement a national screening program, and assess the neurological outcomes of screen-positive infants. Planned studies:

1. 1.A review will analyze current screening strategies and the impact of delayed diagnosis on brain outcomes
2. 2.A nationwide, prospective study in Denmark will implement UCBG screening in all newborns. Infants with arterial UCBG below 3.5 mmol/L will undergo hypoglycemia monitoring and diagnostic testing. Diagnostic accuracy and optimal thresholds will be evaluated.
3. 3.Neurological follow-up at 6 months will assess development using standardized cognitive and motor tests, EEG, and MRI.
4. 4.A retrospective observational study to investigate whether UCBG can provide improved risk stratification for hypoglycaemia in infants born to mothers with diabetes.

Conditions

Congenital Hyperinsulinism (CHI)

Keywords

Newborn Screening; Umbilical cord glucose; CHI; UCBG; Hyperinsulinism

Outcome Measures

Primary Outcomes (2)

• Diagnostic performance of arterial umbilical cord blood glucose (UCBG) screening for pathological neonatal hyperinsulinism

  Diagnostic accuracy of arterial umbilical cord blood glucose (UCBG) measured at birth for identification of pathological neonatal hyperinsulinism using a predefined screening threshold of ≤3.5 mmol/L. Diagnostic accuracy will be summarized by the area under the receiver operating characteristic curve (AUC).

  Birth to 72 hours of age

• Neurodevelopmental outcome in infants diagnosed with pathological neonatal hyperinsulinism through UCBG screening

  Presence of neurodevelopmental impairment at approximately 6 months of age, defined according to a prespecified composite assessment including Bayley-IV, EEG, and brain MRI findings.

  Approx. 6 months of age

Study Arms (1)

Arterial UCBG screen positive

EXPERIMENTAL

Screen-positive infants will undergo two blood glucose measurements during the first hours after birth. Infants with a very low arterial UCBG (\<2.5 mmol/L) will undergo a total of six glucose and G-BOBH measurements.

Diagnostic Test: For the screening, the interventions will be glucose measurements (and possibly G-BOBH), while follow-up assessments will include Bayley testing, EEG, and MRI.

Interventions

For the screening, the interventions will be glucose measurements (and possibly G-BOBH), while follow-up assessments will include Bayley testing, EEG, and MRI. DIAGNOSTIC_TEST

For the majority of included newborns in the screening cohort, two blood glucose measurements will be obtained during the first hours after birth. For infants with an arterial UCBG \< 2.5 mmol/L, six glucose (and G-BHOB) measurements will be performed. Bayley assessment, EEG, and MRI will be conducted once, when cases with CHI reach 6 months of age.

Arterial UCBG screen positive

Eligibility Criteria

• Age: Up to 8 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Study 2:
• Live-born neonates delivered at participating Danish hospitals during the study period.
• arterial umbilical cord blood glucose (UCBG) ≤3.5 mmol/L.
• Written informed consent obtained from parent(s) or legal guardian(s).
• Study 3:
• Infants diagnosed with pathological neonatal hyperinsulinism (HI) following UCBG screening in Study 2.
• Written informed consent obtained from parent(s) or legal guardian(s) for participation in the follow-up study.

You may not qualify if:

• Study 2:
• Missing or unsuccessful arterial umbilical cord blood sampling resulting in an unavailable UCBG measurement.
• Withdrawal of parental consent.
• Study 3:
• Withdrawal of parental consent.

Sponsors & Collaborators

• Odense University Hospital: lead
• Aarhus University Hospital Skejby: collaborator
• Rigshospitalet, Denmark: collaborator
• Aalborg University Hospital: collaborator
• Region Syddanmark: collaborator
• Radiometer Medical ApS: collaborator
• Congenital Hyperinsulinism International: collaborator

MeSH Terms

Conditions

Congenital Hyperinsulinism; Hyperinsulinism

Interventions

Electroencephalography; Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hypoglycemia

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Tomography; Diagnostic Imaging

Central Study Contacts

Julie Siersbæk, MD, Ph.d.-student

CONTACT

+45 21194289; julie.sierbaek@rsyd.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: August 31, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: August 31, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: 1 year after puplication of results