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

Primary Purpose

Preterm, Very Low Birth Weight Infant, Feeding, Breast

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Protein supplementation based on plasma urea concentration every other week or human milk analysis on experiment
Sponsored by
Hospital Universitario La Paz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Preterm focused on measuring preterm, nutrition, human milk fortified

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • University Hospital La PazRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Fortification adjusted according to urea

Individualized fortification according to the nutritional characteristics of breast milk

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Mineralization differences between both fortication methods
Difference in phosphate and alkaline phosphatase values

Full Information

First Posted
July 5, 2021
Last Updated
July 19, 2021
Sponsor
Hospital Universitario La Paz
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1. Study Identification

Unique Protocol Identification Number
NCT04982133
Brief Title
Weight Gain in Extremely Premature Infant With Target Versus Adjusted Fortification
Acronym
FORTIN
Official Title
Randomised Trial Weight Gain in Extremely Premature Infant: Target Versus Adjusted Fortification
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Recruiting
Study Start Date
April 19, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario La Paz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm, Very Low Birth Weight Infant, Feeding, Breast, Food, Fortified
Keywords
preterm, nutrition, human milk fortified

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fortification adjusted according to urea
Arm Type
Active Comparator
Arm 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.
Arm Title
Individualized fortification according to the nutritional characteristics of breast milk
Arm Type
Experimental
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Protein supplementation based on plasma urea concentration every other week or human milk analysis on experiment
Other Intervention Name(s)
Macronutrient supplementation based on human milk analysis
Intervention Description
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.
Primary Outcome Measure Information:
Title
Growth rate 28 days after the start of fortification and birth
Description
To investigate the effect on weight gain during admission of individualized fortification, according to milk analysis, versus fortification adjusted according to urea level.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Mineralization differences between both fortication methods
Description
Difference in phosphate and alkaline phosphatase values
Time Frame
Until 36 weeks of postmenstrual age (EPM) or at discharge

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MIGUEL S DE PIPAON
Phone
619727993
Email
msaenzdepipaon@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MARTA CABRERA
Organizational Affiliation
La Paz University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MIGUEL S DE PIPAON
Phone
619727993
Email
msaenzdepipaon@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Weight Gain in Extremely Premature Infant With Target Versus Adjusted Fortification

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