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The study will evaluate the effect of oral formulation of insulin on preterm infants, born between 26-33 weeks of pregnancy, weighing over 750 grams, who meet the inclusion and exclusion criteria established in this protocol.
The study will aim to determine whether an oral formulation of insulin administration enhances gastrointestinal maturation. The gastrointestinal maturation will be evaluated by the ability of premature infants to achieve complete enteral feeds. The insulin concentration administered in the study is physiological and within the insulin concentration range present in human breast milk and colostrum.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Formulation of Insulin | Experimental | Oral formulation of insulin fed concomitantly with premature infant formula |
|
| Oral Formulation of Placebo | Placebo Comparator | Oral formulation of placebo fed concomitantly with premature infant formula |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Formulation of Insulin | Biological | Oral formulation of insulin fed concomitantly with infant formula |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of days to achieve complete enteral feeding | Up to 28 days or discharge and at 3 months of age |
| Measure | Description | Time Frame |
|---|---|---|
| Number of gastric residual > 2 ml/kg | Up to 28 days or discharge, at 3 months of age | |
| Number of gastric residual > 50% of previous feeding | Up to 28 days or discharge and at 3 months of age | |
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Inclusion Criteria:
1. Pre-term infants 26-33 weeks gestation.
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| Name | Affiliation | Role |
|---|---|---|
| Naim Shehadeh, Prof. | Rambam Health Care Campus | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NICU, Laniado Hospital | Netanya | 4244916 | Israel |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Placebo | Biological | Oral formulation of placebo fed concomitantly with infant formula |
|
| Number of days to discharge |
| Up to 28 days or discharge and at 3 months of age |
| Weight gain | Up to 28 days or discharge and at 3 months of age |
| D000091642 | Urogenital Diseases |