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Completed

NCT Number: NCT04982133

Weight Gain in Extremely Premature Infant With Targeted Versus Adjusted Fortification

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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Key information

Conditions

Preterm Behavior Breast Feeding Feeding Behavior Feeding, Breast Female Urogenital Diseases and Pregnancy Complications Food, Fortified Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases Very Low Birth Weight Infant

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital La Paz

Madrid, 28046, Spain

About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

Other names: Macronutrient supplementation based on human milk analysis

Primary outcomes

  1. Growth rate 28 days after the start of fortification and birth

    Time frame: 28 days

    To investigate the effect on weight gain during admission of individualized fortification, according to milk analysis, versus fortification adjusted according to urea level.

Secondary outcomes

  1. Mineralization differences between both fortication methods

    Time frame: Until 36 weeks of postmenstrual age (EPM) or at discharge

    Difference in phosphate and alkaline phosphatase values

Sponsors and collaborators

Lead sponsor

Hospital Universitario La Paz

Other

Registry information

Official study title

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

Acronym: FORTIN

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jul 29, 2021
Registry last updated
Jan 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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