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High fetal catecholamines - a cause for neonatal hypoglycemia and transient hyperinsulinism?

High fetal catecholamines - a cause for neonatal hypoglycemia and transient hyperinsulinism?

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00022471
Enrollment
300
Registered
2021-04-26
Start date
2021-05-03
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

E16.1 P70.4

Interventions

Group 1: Children with a risk factors for hypoglycemia and their mothers. Group 2: Control group: Children without risk factors for hypoglycemia and their mothers.

Sponsors

Universitätsklinikum Düsseldorf
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Pregnant women with their unborn child: participants will be assigned to the risk group if the child is IUGR, SGA (birth weight 10th percentile), premature (35+0-36+6 weeks of gestation), has a mother with diabetes/gestational diabetes, pre-/eclampsia or if the child suffers from birth asphyxia. Children without any of the above-mentioned risk factors will be assigned to the control group.

Exclusion criteria

Exclusion criteria: Lack of parental consent. Prematurity <35+0 weeks of gestation.

Design outcomes

Primary

MeasureTime frame
1) Do infants with different risk factor for hypoglycemia (SGA, IUGR, LGA, late preterm, asphyxiated or have a mother with diabetes or pre-/eclampsia etc.(data will be obtained from the medical file) have higher levels of catecholamines in AF and/or arterial cord blood compared to a control group without risk factors (at the time of birth)? 2) Do higher levels of catecholamines/its metabolites (in amniotic fluid and/or arterial cord blood at the time of birth) correlate with lower blood glucose levels and longer duration of hypoglycemia (regular blood glucose measurements will be done according to the SOP of our hospital)?

Secondary

MeasureTime frame
1. Do one or more catecholamines/metabolites in AF and/or arterial cord blood serve as a screening parameter to predict the risk for hypoglycemia? 2. Do the levels of catecholamines in AF correlate with the levels of catecholamines and insulin in arterial cord blood? 3. Do the levels of catecholamines/its metabolites differ between the risk groups? 4. Does the duration of prenatal risk factor exposure correlates with the levels of catecholamines and with the postnatal blood glucose levels? 5. Do the catecholamine and insulin levels in maternal blood correlate with the catecholamine and insulin levels in cord blood? 6. Do other factors like maternal BMI, maternal medication, smoking, alcohol, and other drugs etc. have an influence on the catecholamine levels and/or postnatal blood glucose levels? 7. Do the levels of catecholamines correlate with the postnatal need for oral glucose gel, intravenous glucose, subcutaneous glucagon, diazoxide, admission to the children’s hospital and duration of hospitalization? 8. Do children who are born via vaginal delivery or via secondary caesarean section have higher levels of catecholamines compared to children born via primary caesarean-section and if yes, do these children have a later onset of hypoglycemia due to a catecholamine surge during birth, which might inhibit insulin secretion in the first hours of life? 9. Do catecholamine levels correlate with the onset of suspect/pathological cardiotocographies? 10. Does a rupture of the membranes and the subsequent duration until birth have an influence on the catecholamine concentrations in the umbilical cord blood? 11. Does an induction of labor has an influence on the catecholamine levels in AF and cord blood? 12. Does the duration of birth has an impact on the catecholamine levels and subsequently on the postnatal blood glucose levels? 13. Do the fetal blood glucose and lactate concentrations differ from the maternal blood glucose and lactate concentration

Countries

Germany

Contacts

Public ContactHenrike Hörmann

Universitätsklinikum Düsseldorf, Klinik für Allgemeine Pädiatrie, Neonatologie und Kinderkardiologie

henrike.hoermann@med.uni-duesseldorf.de0049-211-81-17687

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026