Growth AccelerationEFORT-LMNCT03191617
Nutrition of Premature Infants With Human Breastmilk Fortifier
A study testing Human milk fortifier in people with Growth Acceleration, run by NEOCOSUR at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 40 days
- Conditions the study is for
- Growth Acceleration
- What is being tested?
- Human milk fortifier
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChile
- Study dates
- Sep 2015to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 40 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
Pontificia universidad Catolica de Chile
Santiago, Santiago Metropolitan, 8330024
JOSE L TAPIA, MD, 56-9-92318797, jlta@med.puc.cl
About this study
Official title: 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.
Read the 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.
- Conditions
- Growth Acceleration
- Being tested
- Human milk fortifier
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human milk fortifierDietary supplement
Also called Mead Johnson´s Liquid Human Milk fortifier
Fortification of breastmilk with liquid human milk fortifier in premature infants
| Study group | Role | What they receive |
|---|---|---|
| Liquid human milk fortifier | Experimental | Liquid human milk fortifier which has higher protein content and also LCPUFA Receives: Dietary Supplement: Human milk fortifier |
| Powder human milk fortifier | Active comparator | Powder human milk fortifier with less protein content and no LCPUFA Receives: Dietary Supplement: Human milk fortifier |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 ( weight is one criteria for discharge)
Measured: 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
Measured: 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
Measured: 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.
Measured: Between entering study and 45 days in study or discharge, if discharge is first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study startSep 2015
- Primary completionAug 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth AccelerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NEOCOSUR
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patricia Mena Nannig, NEOCOSUR
- Investigators
- Patricia Mena, MD, Principal investigator, Hospital Sotero Del Rio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03191617
- Sponsor's protocol ID
- NEOCOSUR
- Acronym
- EFORT-LM
- Status last verified
- Mar 2019
- First submitted
- 19 Nov 2015
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition of Premature Infants With Human Breastmilk Fortifier With Higher Protein Content and Long Chain Poli- Unsaturated Fatty Acids (LCPUFA)
- ClinicalTrials.gov ID
- NCT03191617
- Acronym / sponsor ID
- EFORT-LM / NEOCOSUR
- Conditions
- Growth Acceleration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- NEOCOSURUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 19 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liquid human milk fortifier | Experimental | Dietary Supplement: Human milk fortifierLiquid human milk fortifier which has higher protein content and also LCPUFA |
| Powder human milk fortifier | Active comparator | Dietary Supplement: Human milk fortifierPowder human milk fortifier with less protein content and no LCPUFA |
Who may qualify
- Ages
- 3 to 40 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human milk fortifierAlso: Mead Johnson´s Liquid Human Milk fortifierFortification of breastmilk with liquid human milk fortifier in premature infants | Dietary supplement | Liquid human milk fortifier, Powder human milk fortifier |
Primary outcome
Weight and linear growth
Time frame: between entering study and 45 days in study or discharge, whatever first
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
4 secondary outcomes
Compare length of hospital- stay
Time frame: days from the first day of study to discharge home , an average of 37 weeks of postconceptual age
Compare feeding tolerance
Time frame: 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
Time frame: 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
Time frame: Between entering study and 45 days in study or discharge, if discharge is first
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Growth Acceleration
Recruiting
Probiotic Supplementation in Extremely Preterm Infants in Scandinavia
Necrotizing Enterocolitis, Death
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Mena, MD principal investigator
Hospital Sotero Del Rio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Human milk fortifier in people with Growth Acceleration, run by NEOCOSUR at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniela Masoli, MD (56-9-95453952, daniela.masoli@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight and linear growth (time frame: between entering study and 45 days in study or discharge, whatever first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2019.