Weight Gain in Extremely Premature Infant With Target Versus Adjusted Fortification

Study Overview
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Brief Summary
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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
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Study design This is an interventional, randomized, controlled study. 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. 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.

Official Title
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Randomised Trial Weight Gain in Extremely Premature Infant: Target Versus Adjusted Fortification

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

Intervention / Treatment
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* Dietary Supplement: Protein supplementation based on plasma urea concentration every other week or human milk analysis on experiment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Preterm infants born <1000 g of birth weight that are fed with breast milk or donated milk. Written informed consent signed by the mother, father or legal guardian. To tolerate enteral feeding, at least 100mL / kg / day. Exclusion Criteria: Non-premature or premature patients weighing ≥ 1000 gr. Patients with major malformations. Patients with diagnosed chromosomal diseases or of high diagnostic suspicion. Patients with short bowel syndrome or any surgery on the gastrointestinal tract.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fortification adjusted according to urea<br>Fortification adjusted according to urea with FM 85 at 4% and oligopeptides. In this arm, fortification at 4% is started, and according to plasma urea control every 15 days the fortification is modified. | Dietary Supplement: Protein supplementation based on plasma urea concentration every other week or human milk analysis on experiment<br>* 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.<br>* Other names: Macronutrient supplementation based on human milk analysis;|
| Experimental: Individualized fortification according to the nutritional characteristics of breast milk<br>Individualized fortification according to the nutritional characteristics of the mother's own milk or pasteurized milk taken by the premature infant. In this arm, fortification is adjusted based on the macronutrient analysis of breast milk or donated twice weekly. | Dietary Supplement: Protein supplementation based on plasma urea concentration every other week or human milk analysis on experiment<br>* 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.<br>* Other names: Macronutrient supplementation based on human milk analysis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mineralization differences between both fortication methods | Difference in phosphate and alkaline phosphatase values | Until 36 weeks of postmenstrual age (EPM) or at discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preterm, nutrition, human milk fortified