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

Randomised Trial Weight Gain in Extremely Premature Infant: 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.

Study Overview

• Status: Completed
• Conditions: Preterm; Very Low Birth Weight Infant; Food, Fortified; Feeding, Breast
• Intervention / Treatment: Dietary supplement: Protein supplementation based on plasma urea concentration every other week or human milk analysis on experiment

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: MIGUEL S DE PIPAON; Phone Number: 619727993; Email: msaenzdepipaon@gmail.com

Study Locations

• Spain
  • Madrid, Spain, 28046
    • University Hospital La Paz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Dietary supplement: 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.; Other Names: Macronutrient supplementation based on human milk analysis
Experimental: 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.	Dietary supplement: 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.; Other Names: Macronutrient supplementation based on human milk analysis

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital Universitario La Paz
• Investigators: Principal Investigator: MARTA CABRERA, La Paz University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2021
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): April 30, 2023

Study Registration Dates

• First Submitted: July 5, 2021
• First Submitted That Met QC Criteria: July 19, 2021
• First Posted (Actual): July 29, 2021

Study Record Updates

• Last Update Posted (Estimated): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 20, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: nutrition; preterm; human milk fortified
• Additional Relevant MeSH Terms: Body Weight Changes; Body Weight; Birth Weight; Weight Gain
• Other Study ID Numbers: HULP5704

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data underlying the results reported in this article after deidentification (text, tables, figures and appendices) will be available upon request. Data will be available 3 months to 5 years after publication of the article. Other documents will be available: study protocol, informed consent form. Researchers submitting a methodologically sound proposal should contact miguel.saenz@salud.madrid.org. In order to access, requesters will need to sign a data access agreement.
• IPD Sharing Time Frame: Data will be available 3 months to 5 years after publication of the article.
• IPD Sharing Access Criteria: Researchers submitting a methodologically sound proposal should contact miguel.saenz@salud.madrid.org. In order to access, requesters will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No