Growth Acceleration Clinical Trial
— EFORT-LMOfficial title:
Nutrition of Premature Infants With Human Breastmilk Fortifier With Higher Protein Content and Long Chain Poli- Unsaturated Fatty Acids (LCPUFA)
NCT number | NCT03191617 |
Other study ID # | NEOCOSUR |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2015 |
Est. completion date | December 2019 |
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.
Status | Recruiting |
Enrollment | 160 |
Est. completion date | December 2019 |
Est. primary completion date | August 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 40 Days |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Chile | Pontificia universidad Catolica de Chile | Santiago | Metropolitana |
Lead Sponsor | Collaborator |
---|---|
NEOCOSUR |
Chile,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01489098 -
Effect of the Level of Dietary Protein on Body Composition
|
N/A | |
Completed |
NCT02170428 -
Diet and Well-being of Young Danish Children
|
||
Completed |
NCT02403739 -
Visual Interpretation of Neonatal Growth Charts
|
N/A | |
Completed |
NCT02484495 -
Extended Pilot Project Community Based Production of Complementary Food in Ethiopia
|
N/A | |
Withdrawn |
NCT03673566 -
Clinical Evaluation of the "NICU Clinical Decision Support Dashboard" - CHMCO
|
N/A | |
Completed |
NCT04506541 -
The Effects Of KC On Exclusively Breastfeeding And Baby's Growth And Development According To Attachment Theory
|
N/A | |
Withdrawn |
NCT03673579 -
Clinical Evaluation of the "NICU Clinical Decision Support Dashboard" - MHSB
|
N/A | |
Completed |
NCT03384719 -
The Effect of Milk Protein vs Blends of Milk and Plant Protein on Growth Markers in 7-8 Year Old Healthy Danish Children
|
N/A | |
Completed |
NCT02586571 -
Growth and Body Composition in Breastfed Infants - Study on Age of Introduction of Complementary Foods in Iceland
|
||
Recruiting |
NCT05604846 -
Probiotic Supplementation in Extremely Preterm Infants in Scandinavia
|
N/A | |
Completed |
NCT03574350 -
Effect on Early Somatic Growth of a Daily Kinesthetic Stimulation on Preterm Infants
|
N/A | |
Completed |
NCT02239588 -
Evaluation of the Effect of Pure Canterbury Stage 1 Infant Formula Milk Powder on the Growth of Infant 0-6 Months of Age
|
Phase 4 |