Neonatal hypoglycemia
Conditions
Interventions
Real-time CGM-assisted management group:On the basis of routine glucose screening, confirmatory testing, and clinical management according to the current neonatal glucose management protocol of the ho
Conventional intermittent blood glucose monitoring group:Participants will receive conventional intermittent blood glucose screening, confirmatory testing, and clinical management according to the cur
Sponsors
Obstetrics and Gynecology Hospital of Fudan University
Eligibility
Sex/Gender
All
Age
No minimum to 1 Months
Inclusion criteria
Inclusion criteria: 1.Gestational aged >= 37 weeks; 2.Neonates within 72 hours after birth, with priority given to those who can start monitoring within 24 hours after birth; 3.Presence of at least one risk factor for hypoglycemia, including large for gestational age, small for gestational age, macrosomia, neonates of mothers with abnormal glucose metabolism, perinatal asphyxia or stress, hypothermia, risk of infection, respiratory maladaptation, delayed establishment of feeding, etc.; 4.Clinically requiring early postnatal blood glucose monitoring; 5.Expected to complete at least 48 hours of CGM monitoring or collection of the main clinical data within 72 hours after birth; 6.The guardian has been fully informed and has signed the written informed consent form.
Exclusion criteria
Exclusion criteria: 1.Confirmed or suspected severe congenital malformations; 2.Confirmed or highly suspected inherited metabolic diseases, endocrine disorders, or other diseases that may significantly affect glucose metabolism; 3.Severe infection, shock, circulatory instability, need for emergency resuscitation, or conditions judged by the investigator to be temporarily unsuitable for CGM use; 4.Skin damage, infection, obvious rash, severe edema, or other conditions at the proposed sensor insertion site that are unsuitable for sensor placement; 5.Expected transfer to another hospital, withdrawal of treatment, or inability to complete the main observation procedures within a short period after birth; 6.The guardian refuses participation in the study or is unable to complete the informed consent process; 7.Other conditions judged by the investigator to be unsuitable for inclusion in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of persistent or recurrent hypoglycemic events within the first 72 hours after birth; | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of hypoglycemic events;Time below target range;Total duration of hypoglycemia;Incidence of severe hypoglycemia;The time required for blood glucose to return to the target range; | — |
Countries
China
Contacts
Public ContactWang Jimei
Obstetrics and Gynecology Hospital of Fudan University
Outcome results
None listed