Preterm Clinical Trial
— FORTINOfficial title:
Randomised Trial Weight Gain in Extremely Premature Infant: Targeted Versus Adjusted Fortification
NCT number | NCT04982133 |
Other study ID # | HULP5704 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 19, 2021 |
Est. completion date | April 30, 2023 |
Verified date | January 2024 |
Source | Hospital Universitario La Paz |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Investigation about the effect on weight gain in extremely low birth weight preterm with individualized fortification, according to human milk analysis versus fortification adjusted according to urea serum concentration.
Status | Completed |
Enrollment | 38 |
Est. completion date | April 30, 2023 |
Est. primary completion date | April 30, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: 1. Preterm infants born <1000 g of birth weight that are fed with breast milk or donated milk. 2. Written informed consent signed by the mother, father or legal guardian. 3. To tolerate enteral feeding, at least 100mL / kg / day. Exclusion Criteria: 1. Non-premature or premature patients weighing = 1000 gr. 2. Patients with major malformations. 3. Patients with diagnosed chromosomal diseases or of high diagnostic suspicion. 4. Patients with short bowel syndrome or any surgery on the gastrointestinal tract. |
Country | Name | City | State |
---|---|---|---|
Spain | University Hospital La Paz | Madrid |
Lead Sponsor | Collaborator |
---|---|
Hospital Universitario La Paz |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Growth rate 28 days after the start of fortification and birth | To investigate the effect on weight gain during admission of individualized fortification, according to milk analysis, versus fortification adjusted according to urea level. | 28 days | |
Secondary | Mineralization differences between both fortication methods | Difference in phosphate and alkaline phosphatase values | Until 36 weeks of postmenstrual age (EPM) or at discharge |
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