Nutrition of Premature Infants With Human Breastmilk Fortifier

NCT03191617 | Unknown DMC

• 1 other identifier: NEOCOSUR
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Growth Acceleration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Compare length of hospital- stay

  days from the first day of study to discharge home , an average of 37 weeks of postconceptual age

• Compare feeding tolerance

  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

  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

  Between entering study and 45 days in study or discharge, if discharge is first

Study Arms (2)

Liquid human milk fortifier

EXPERIMENTAL

Liquid human milk fortifier which has higher protein content and also LCPUFA

Dietary Supplement: Human milk fortifier

Powder human milk fortifier

ACTIVE COMPARATOR

Powder human milk fortifier with less protein content and no LCPUFA

Dietary Supplement: Human milk fortifier

Interventions

Human milk fortifier DIETARY_SUPPLEMENT

Fortification of breastmilk with liquid human milk fortifier in premature infants

Also known as: Mead Johnson´s Liquid Human Milk fortifier

Liquid human milk fortifier; Powder human milk fortifier

Eligibility Criteria

• Age: 3 Days - 40 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• NEOCOSUR: lead

Study Sites (1)

Pontificia universidad Catolica de Chile

Santiago, Santiago Metropolitan, 8330024, Chile

RECRUITING

Study Officials

• Patricia Mena, MD

  Hospital Sotero Del Rio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniela Masoli, MD

CONTACT

56-9-95453952; daniela.masoli@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 19, 2015
• First Posted: June 19, 2017
• Study Start: September 1, 2015
• Primary Completion: August 1, 2019
• Study Completion: December 1, 2019
• Last Updated: March 28, 2019

Record last verified: 2019-03

Locations

CL (1)