Weight Gain in Extremely Premature Infant With Target Versus Adjusted Fortification

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    38
  • sponsor
    Hospital Universitario La Paz
Updated on 4 August 2021
preterm delivery

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.

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 infants 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.

Details
Condition Very low birth weight infant, fortified food, Preterm, Breast Feeding
Treatment Protein supplementation based on plasma urea concentration every other week or human milk analysis on experiment
Clinical Study IdentifierNCT04982133
SponsorHospital Universitario La Paz
Last Modified on4 August 2021

Eligibility

Yes No Not Sure

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
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