Skip to content

Study of Cornstarch Therapy for Neonatal Hyperinsulinism-Induced Hypoglycemia

Study on the safety and effectiveness of cornstarch treatment in neonates with hyperinsulinism-induced hypoglycemia

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs061260016
Enrollment
5
Registered
2026-05-19
Start date
2026-05-19
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Hyperinsulinism-Induced Hypoglycemia

Interventions

Cornstarch (2g/kg/day) will be orally administered mixed with breast milk or formula, 8 times a day for 3 consecutive days. In Group A, cornstarch-containing milk will be fed for 3 days, followed by a

Sponsors

Washio Yousuke
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The subjects of this study will meet all of the following criteria: 1.Infants hospitalized in Okayama University Hospital. 2.Infants with a corrected gestational age of 37 weeks or more 3.Infants less than 9 months corrected age. 4.Infants diagnosed with hyperinsulinism-induced hypoglycemia and for whom it is difficult to discontinue intravenous nutrition due to hypoglycemia. 5.Infants for whom enteral nutrition has been established. 6.Infants whose blood glucose levels are stable under treatment . 7.Infants whose parents have provided written consent based on a full understanding of the study after receiving sufficient explanation.

Exclusion criteria

Exclusion criteria: 1.Infants for whom stable oral medication treatment is difficult due to vomiting or other issues. 2.Infants with severe congenital malformation syndromes that affect life prognosis. 3.Infants whom the principal investigator or co-investigators deem unsuitable for inclusion in the study.

Design outcomes

Primary

MeasureTime frame
lowest blood glucose levels before milk feedings

Secondary

MeasureTime frame
1.Adverse events 2.Changes in blood glucose levels

Contacts

Public ContactAsami Oyama

Okayama University Hospital

me20029@s.okayama-u.ac.jp+81-86-235-3432

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026