Nutrition of Premature Infants With Human Breastmilk Fortifier (EFORT-LM)

Nutrition of Premature Infants With Human Breastmilk Fortifier With Higher Protein Content and Long Chain Poli- Unsaturated Fatty Acids (LCPUFA)

The objective of the study is to compare two human milk fortifiers with different protein content and LCPUFA in a group of very low birth weight infants.

Study Overview

• Status: Unknown
• Conditions: Growth Acceleration
• Intervention / Treatment: Dietary supplement: Human milk fortifier

Detailed Description

This study is a multi-center, third party-blinded, randomized, controlled, parallel- group, prospective trial comparing growth with a liquid human milk fortifier with higher protein content and LCPUFA and a control powdered human milk fortifier added to breast milk and fed to premature infants. The trial will be conducted in 11 centers in Chile. The enrollment period is expected to be approximately 18 months. To allow for dropouts, approximately 160 participants will be randomized.

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniela Masoli, MD; Phone Number: 56-9-95453952; Email: daniela.masoli@gmail.com

Study Locations

• Chile
  • Metropolitana
    • Santiago, Metropolitana, Chile, 8330024
      • Recruiting
      • Pontificia Universidad Catolica de Chile
      • Contact: JOSE L TAPIA, MD; Phone Number: 56-9-92318797; Email: jlta@med.puc.cl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 days to 1 month (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Premature infant equal or under 31 weeks gestational age at birth
• Birth weight equal or under 1,250 g
• Predominantly fed breast milk (mother's milk or donor milk) on study day 0
• Appropriate birth weight for gestational age (AGA) - defined as birth weight between and inclusive of the 10th and 90th percentiles on the Fenton growth chart
• Singleton or twin birth (both twins do not need to qualify and be randomized into study)
• Birth weight is ≤1,000 g and participant is ≤ 40 days of age on study day 0
• Birth weight is above 1,000 g and participant is ≤ 30 days of age on study day 0
• Enteral intake of 80 mL/kg/d of unfortified breast milk on study day 0
• Anticipate mother's willingness to breast milk for at least 28 days from study day 0
• Signed informed consent obtained

Exclusion Criteria:

• History of underlying metabolic or chronic disease, congenital malformation, or any other condition which, in the opinion of the Investigator, is likely to interfere with: the ability of the participant to ingest food, normal growth and development of the participant, or the evaluation of the participant
• 5 minute APGAR score ≤ 4
• Major surgery that required general anesthesia prior to first day study (note: persistent ductus arterious ligation is allowed)
• Received pharmacologic doses of glucocorticoids during 3 consecutive days (72 hours) prior to or on day one of study (physiologic hydrocortisone administration up to 1.5 mg/kg/d is permitted)
• Ventilator-dependent and requiring ≥ 40% fraction of inspired oxygen (FiO2) on day one of study (ventilator dependent and requiring ≤ 40% FiO2 and/or nasal canula, and/or nasal continous positive airway pressure (CPAP) and/or oxygen hood is allowed)
• Grade III or IV bilateral intraventricular hemorrhage (IVH) prior to or on study day one
• Feeding intolerance to breast milk feedings on study day one
• Consumption of more than 3 feedings or 12 hours of continuous feeds of fortified breast milk prior to study day one
• Fluid restriction < 120 mL/kg/d
• History of creatinine >2.0 mg/dL 7 days prior to or on study day one
• Currently receiving or plan use of probiotics

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Liquid human milk fortifier; Liquid human milk fortifier which has higher protein content and also LCPUFA	Dietary supplement: Human milk fortifier; Fortification of breastmilk with liquid human milk fortifier in premature infants; Other Names: Mead Johnson´s Liquid Human Milk fortifier
Active Comparator: Powder human milk fortifier; Powder human milk fortifier with less protein content and no LCPUFA	Dietary supplement: Human milk fortifier; Fortification of breastmilk with liquid human milk fortifier in premature infants; Other Names: Mead Johnson´s Liquid Human Milk fortifier

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight and linear growth	Weight increase in g/K/day and knee-to-heel length increase in mm/weeks, measured in one scale (+-5 g) and one kneenometer (special device to measure longitude) (+- 1mm) by one person for each center between entering study and 45 days in study or discharge	between entering study and 45 days in study or discharge, whatever first

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare length of hospital- stay	days from the first day of study to discharge home ( weight is one criteria for discharge)	days from the first day of study to discharge home , an average of 37 weeks of postconceptual age
Compare feeding tolerance	Daily record of residue, regurgitation and suspend of gastric feedings	Between entering study and 45 days in study or discharge, if discharge first
Compare incidence of main preterm morbidities: necrotizing enterocolitis, bronchopulmonary dysplasia, retinopathy of prematurity and sepsis	Incidence of necrotizing enterocolitis grade II or more, bronchopulmonary dysplasia as additional oxygen at 36 postconceptual weeks, retinopathy of prematurity with treatment and sepsis with positive hemoculture	Between entering study and 45 days in study or discharge, if discharge is first
Compare cost/benefits . The cost of use a fortificant and the benefit of growth velocity	compare cost of total amount of fortifier used compare with cost of number of days of hospitalization, number of days in neonatal intensive care unit in each group.	Between entering study and 45 days in study or discharge, if discharge is first

Collaborators and Investigators

• Sponsor: NEOCOSUR
• Investigators: Principal Investigator: Patricia Mena, MD, Hospital Sotero del Rio

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Anticipated): August 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: November 19, 2015
• First Submitted That Met QC Criteria: June 15, 2017
• First Posted (Actual): June 19, 2017

Study Record Updates

• Last Update Posted (Actual): March 28, 2019
• Last Update Submitted That Met QC Criteria: March 27, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: NEOCOSUR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided