Weight Gain in Extremely Premature Infant With Targeted Versus Adjusted Fortification

Preterm Clinical Trial

— FORTIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04982133
• Other study ID #: HULP5704
• Status: Completed
• Phase: N/A
• Start date: April 19, 2021
• Est. completion date: April 30, 2023

Study information

• Verified date: January 2024
• Source: Hospital Universitario La Paz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Birth Weight
• Body Weight
• Feeding, Breast
• Food, Fortified
• Preterm
• Very Low Birth Weight Infant
• Weight Gain

Intervention

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.

Locations

Country	Name	City	State
Spain	University Hospital La Paz	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario La Paz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mineralization differences between both fortication methods	Difference in phosphate and alkaline phosphatase values	Until 36 weeks of postmenstrual age (EPM) or at discharge