NIPH Clinical Trials Search

Study of Cornstarch Therapy for Neonatal Hyperinsulinism-Induced Hypoglycemia

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Hyperinsulinism-Induced Hypoglycemia
Date of first enrollment	19/05/2026
Target sample size	5
Countries of recruitment
Study type	Interventional
Intervention(s)	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 1-day observation period, and then normal breast milk or formula will be fed for 3 days. In Group B, normal breast milk or formula will be fed for 3 days, followed by a 1-day observation period, and then cornstarch-containing milk will be fed for 3 consecutive days. Continuous blood glucose monitoring will be conducted during the intervention period.

Outcome(s)

Primary Outcome	lowest blood glucose levels before milk feedings
Secondary Outcome	1.Adverse events 2.Changes in blood glucose levels

Key inclusion & exclusion criteria

Age minimum	Not applicable
Age maximum	Not applicable
Gender	Both
Include 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.
Exclude 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.