NCT04982133

Weight Gain in Extremely Premature Infant With Targeted Versus Adjusted Fortification

Randomised Trial Weight Gain in Extremely Premature Infant: Targeted Versus Adjusted Fortification

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Hospital Universitario La Paz · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

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.

Detailed description

1. Study design This is an interventional, randomized, controlled study. 2. Description of the study The very premature newborn will be identified by daily evaluation of the infants admitted for consultation in the income book. Informed consent will be requested from the infant´s father, mother or legal guardian between the fifth and tenth day of life. Fortification will be done according to the randomization group. 3. Outline of the study design * Excel calculation sheet of individualized supplementation according to the composition of breast milk in the target fortification group. Methodology of analysis of breast milk in FOSS analyzer. * In the adjusted fortification group, urea concentration levels will be kept between 19-30 mg / dL * Fenton curves or https://www.growthcalculator.org/ will be used for Z-scores calculation. * Growth speed calculation: Weight gain: (1000x ln \[Final weight / Initial weight\]) / number of days. 4 Duration of the study for each participant The duration of participation in the study and the fortification intervention period will be a maximum of 132 days.

Conditions

• Preterm
• Very Low Birth Weight Infant
• Feeding, Breast
• Food, Fortified

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Protein supplementation based on plasma urea concentration every other week or human milk analysis on experiment	At the time that the doctor decides to start fortification, it will be done according to urea levels in active comparator arm or human milk analysis on experimental group. In Group A, fortification at 4% is started, and according to plasma urea control every 15 days the fortification is modified. In Group B, fortification is adjusted based on the macronutrient analysis of breast or donated milk.

Timeline

• Start date: 2021-04-19
• Primary completion: 2022-04-30
• Completion: 2023-04-30
• First posted: 2021-07-29
• Last updated: 2024-01-23

Locations

1 site across 1 country: Spain