Weight Gain in Extremely Premature Infant With Targeted Versus Adjusted Fortification

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-19

Study Completion Date

2023-04-30

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.

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Detailed Description

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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

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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Fortification adjusted according to urea

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.

Group Type ACTIVE_COMPARATOR

Protein supplementation based on plasma urea concentration every other week or human milk analysis on experiment

Intervention Type DIETARY_SUPPLEMENT

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.

Individualized fortification according to the nutritional characteristics of breast milk

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.

Group Type EXPERIMENTAL

Protein supplementation based on plasma urea concentration every other week or human milk analysis on experiment

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Macronutrient supplementation based on human milk analysis

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes