Trial | NCT03191617  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    160
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.
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 Started
Sep 30
2015
Primary Completion
Aug 31
2019
Anticipated
Study Completion
Dec 31
2019
Anticipated
Last Update
Mar 28
2019

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

Liquid human milk fortifier Experimental

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

Powder human milk fortifier Active Comparator

Powder human milk fortifier with less protein content and no LCPUFA

Criteria 

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
No Results Posted