Weight Gain in Extremely Premature Infant With Targeted Versus Adjusted Fortification (FORTIN)

Madrid Health Service

Status: Completed

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

Treatments: Dietary Supplement: Protein supplementation based on plasma urea concentration every other week or human milk analysis on experiment

Study type: Interventional

Funder types: Other

Identifiers

NCT04982133

HULP5704

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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38 participants in 2 patient groups

Fortification adjusted according to urea

Active Comparator group

Description:

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.

Treatment:

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

Individualized fortification according to the nutritional characteristics of breast milk

Experimental group

Description:

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.

Treatment:

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