Weight GainNCT03886844
Growth and Weight Gain in ELBW Infants Fed an Exclusively Human Milk Based Diet With Prolacta®
An observational study of Weight Gain and Human Milk, run by Medical University of Vienna at 2 sites in Austria.
Trial summary
Preterm infants are susceptible to postnatal growth restriction. Breast milk is the recommended source of nutrition for preterm infants. As preterm infants have enhanced nutritional requirements, multicomponent fortifiers are added to breast milk in order to establish adequate growth. Read more about this study
- Who is it for?
- Ages 1 day to 8 weeks
- Conditions the study is for
- Weight Gain, Human Milk, Preterm Infants
- What is being tested?
- Human milk fortifier based on human milk (Prolacta)
- How many people
- 196 participants
- Where
- 2 sitesAustria
- Study dates
- Dec 2015to Nov 2018
- Phase
- Observational
- 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 1 day to 8 weeks
- All sexes
- No healthy volunteers
- Child
Study population: ELBW infants (extremely low birth weight infants, <1000g birth weight)
Who may be able to join
- Preterm infants with a birth weight <1000 g
Who cannot join
- Congenital heart disease
- Major congenital birth defects
- Major inborn error of metabolism
Trial locations and contacts
2 sites in 1 country.
Austria2 sites
Paracelsus Medical University
Salzburg, 5020
Medical University of Vienna
Vienna, 1090
About this study
Official title: Prolacta Compare. Growth and Weight Gain in Extremely Low Birth Weight Infants Fed an Exclusively Human Milk Based Diet With Prolacta®
Preterm infants are susceptible to postnatal growth restriction. Breast milk is the recommended source of nutrition for preterm infants. As preterm infants have enhanced nutritional requirements, multicomponent fortifiers are added to breast milk in order to establish adequate growth.
Due to the various benefits of human milk feds to preterm infants, a human milk fortifier based on donor milk (Prolact+6 H2MF® Prolacta, City of Industry, California) has been developed. With this study, the investigators want to evaluate the effect of human milk fortification on weight gain in extremely low birth weight infants (ELBW, <1000g birth weight) in comparison to bovine fortification.
Read the detailed description
Preterm infants are susceptible to postnatal growth restriction. Breast milk is the recommended source of nutrition for preterm infants. Many positive short-term health effects like prevention necrotizing enterocolitis , effects on gut development and immunological issues are associated with breast milk feedings.
The composition of breast milk usually meets the nutritional demands of term infants. As preterm infants have enhanced nutritional requirements, multicomponent fortifiers are added to breast milk in order to establish adequate growth and proper neurodevelopmental outcome.
Due to the various benefits of human milk feds to preterm infants, a human milk fortifier based on donor milk (Prolact+6 H2MF® Prolacta, City of Industry, California) has been developed. This human milk fortifier contains more energy and protein than bovine milk fortifiers. So far, accurate data on growth and weight gain under an exclusive diet with human milk and the human milk fortifier Prolact+6H2MF®are missing. With this study, the investigators want to evaluate the impact of a human milk based fortifier on weight gain in extremely low birth weight infants (ELBW, <1000g birth weight) in comparison to bovine milk based fortifier.
- Conditions
- Weight Gain, Human Milk, Preterm Infants, Extremely Low Birth Weight
- Being tested
- Human milk fortifier based on human milk (Prolacta)
- Keywords
- Infant weight gain, Human milk fortifier, Preterm infants, ELBW infants
- Medical subject headings
- Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human milk fortifier based on human milk (Prolacta)Dietary supplement
Intervention is started with an enteral intake of 100 ml/kg until 32 weeks corrected for prematurity, afterwards a human milk fortifier based on bovine milk is administered until estimated date of birth or 52 weeks corrected for prematurity (weight <10. percentile) according to ESPGHAN(=European Society for paediatric gastroenterology, hepatology and nutrition) guidelines
| Study group | Role | What they receive |
|---|---|---|
| Prolacta group | Infants, who received a human milk fortifier based on human milk (12/2015-11/2018), started with an enteral intake of 100 ml/kg until 32 weeks corrected for prematurity Receives: Dietary Supplement: Human milk fortifier based on human milk (Prolacta) | |
| "Frauenmilch Supplement"=FMS group | Infants, who received a human milk fortifier based on bovine milk (05/2012-06/2015), started with an enteral intake of 100 ml/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
growth velocity g/kg/d at 37+0 weeks
weight gain in g/kg/d
Measured: at 37+0 weeks of gestation
Secondary outcomes (20)
growth velocity g/kg/d at 32+0 weeks
weight gain in g/kg/d
Measured: at 32+0 weeks of gestation
growth velocity g/kg/d from start of fortification to 32+0 weeks
weight gain in g/kg/d
Measured: at 32+0 weeks of gestation
Weight at 32+0
weight in grams
Measured: at 32 weeks of gestation
Weight at 37+0
weight in grams
Measured: at 37+0 weeks of gestation
Length at 32+0
Length in cm
Measured: at 32+0 weeks of gestation
Length gain at 32+0
Length gain in cm/week
Measured: at 32+0 weeks of gestation
Head circumference at 32+0
head circumference in cm
Measured: at 32+0 weeks of gestation
Head circumference gain at 32+0
head circumference gain in cm/week
Measured: at 32+0 weeks of gestation
Length at 37+0
Length in cm
Measured: at 37 weeks of gestation
Lengthgain at 37+0
Lengthgain in cm/week
Measured: at 37 weeks of gestation
Head circumference at 37+0
Head circumference in cm
Measured: at 37 weeks of gestation
Head circumference gain at 37+0
Head circumference gain in cm/week
Measured: at 37 weeks of gestation
Time to full enteral feeds
Day of life when full enteral feeds (140ml/kg) are tolerated
Measured: up to 37 weeks of gestation
Incidence of necrotising enterocolitis
Necrotizing enterocolitis stage 2a according to Bell
Measured: up to 37 weeks of gestation
Body composition
Fat and Fat- free mass measured by Body plethysmography
Measured: up to 6 months corrected for prematurity
Blood parameter total protein
laboratory parameter
Measured: up to 37 weeks of gestation
Blood parameter Urea
laboratory parameter
Measured: up to 37 weeks of gestation
Blood parameter Triglyceride
laboratory parameter
Measured: up to 37 weeks of gestation
Blood parameter Glucose
laboratory parameter
Measured: up to 37 weeks of gestation
z- scores
z-scores for weight , length and head circumference
Measured: at 37 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study startDec 2015
- Primary completionNov 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight GainStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Paracelsus Medical University
- Responsible party
- Principal investigator, Nadja Haiden,MD, Medical University of Vienna
- Investigators
- Assoc. Prof. PD. Nadja Haiden, MD, MSc, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03886844
- Sponsor's protocol ID
- Prolacta
- Status last verified
- Apr 2019
- First submitted
- 19 Mar 2019
- Last updated
- 29 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prolacta Compare. Growth and Weight Gain in Extremely Low Birth Weight Infants Fed an Exclusively Human Milk Based Diet With Prolacta®
- ClinicalTrials.gov ID
- NCT03886844
- Acronym / sponsor ID
- Prolacta
- Conditions
- Weight Gain, Human Milk, Preterm Infants, Extremely Low Birth Weight
- Keywords
- Infant weight gain, Human milk fortifier, Preterm infants, ELBW infants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- Paracelsus Medical University
- Study start
- Dec 2015
- Primary completion
- Nov 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 22 Mar 2019 (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.
Preterm infants are susceptible to postnatal growth restriction. Breast milk is the recommended source of nutrition for preterm infants. As preterm infants have enhanced nutritional requirements, multicomponent fortifiers are added to breast milk in order to establish adequate growth.
Due to the various benefits of human milk feds to preterm infants, a human milk fortifier based on donor milk (Prolact+6 H2MF® Prolacta, City of Industry, California) has been developed. With this study, the investigators want to evaluate the effect of human milk fortification on weight gain in extremely low birth weight infants (ELBW, <1000g birth weight) in comparison to bovine fortification.
Detailed description
Preterm infants are susceptible to postnatal growth restriction. Breast milk is the recommended source of nutrition for preterm infants. Many positive short-term health effects like prevention necrotizing enterocolitis , effects on gut development and immunological issues are associated with breast milk feedings.
The composition of breast milk usually meets the nutritional demands of term infants. As preterm infants have enhanced nutritional requirements, multicomponent fortifiers are added to breast milk in order to establish adequate growth and proper neurodevelopmental outcome.
Due to the various benefits of human milk feds to preterm infants, a human milk fortifier based on donor milk (Prolact+6 H2MF® Prolacta, City of Industry, California) has been developed. This human milk fortifier contains more energy and protein than bovine milk fortifiers. So far, accurate data on growth and weight gain under an exclusive diet with human milk and the human milk fortifier Prolact+6H2MF®are missing. With this study, the investigators want to evaluate the impact of a human milk based fortifier on weight gain in extremely low birth weight infants (ELBW, <1000g birth weight) in comparison to bovine milk based fortifier.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prolacta group | – | Dietary Supplement: Human milk fortifier based on human milk (Prolacta)Infants, who received a human milk fortifier based on human milk (12/2015-11/2018), started with an enteral intake of 100 ml/kg until 32 weeks corrected for prematurity |
| "Frauenmilch Supplement"=FMS group | – | –Infants, who received a human milk fortifier based on bovine milk (05/2012-06/2015), started with an enteral intake of 100 ml/kg |
Who may qualify
- Ages
- 1 day to 8 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- ELBW infants (extremely low birth weight infants, <1000g birth weight)
Key inclusion criteria (1 listed)
- Preterm infants with a birth weight <1000 g
Key exclusion criteria (3 listed)
- Congenital heart disease
- Major congenital birth defects
- Major inborn error of metabolism
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 fortifier based on human milk (Prolacta)Intervention is started with an enteral intake of 100 ml/kg until 32 weeks corrected for prematurity, afterwards a human milk fortifier based on bovine milk is administered until estimated date of birth or 52 weeks corrected for prematurity (weight <10. percentile) according to ESPGHAN(=European Society for paediatric gastroenterology, hepatology and nutrition) guidelines | Dietary supplement | Prolacta group |
Primary outcome
growth velocity g/kg/d at 37+0 weeks
Time frame: at 37+0 weeks of gestation
weight gain in g/kg/d
20 secondary outcomes
growth velocity g/kg/d at 32+0 weeks
Time frame: at 32+0 weeks of gestation
growth velocity g/kg/d from start of fortification to 32+0 weeks
Time frame: at 32+0 weeks of gestation
Weight at 32+0
Time frame: at 32 weeks of gestation
Weight at 37+0
Time frame: at 37+0 weeks of gestation
Length at 32+0
Time frame: at 32+0 weeks of gestation
Length gain at 32+0
Time frame: at 32+0 weeks of gestation
Head circumference at 32+0
Time frame: at 32+0 weeks of gestation
Head circumference gain at 32+0
Time frame: at 32+0 weeks of gestation
Length at 37+0
Time frame: at 37 weeks of gestation
Lengthgain at 37+0
Time frame: at 37 weeks of gestation
Head circumference at 37+0
Time frame: at 37 weeks of gestation
Head circumference gain at 37+0
Time frame: at 37 weeks of gestation
Time to full enteral feeds
Time frame: up to 37 weeks of gestation
Incidence of necrotising enterocolitis
Time frame: up to 37 weeks of gestation
Body composition
Time frame: up to 6 months corrected for prematurity
Blood parameter total protein
Time frame: up to 37 weeks of gestation
Blood parameter Urea
Time frame: up to 37 weeks of gestation
Blood parameter Triglyceride
Time frame: up to 37 weeks of gestation
Blood parameter Glucose
Time frame: up to 37 weeks of gestation
z- scores
Time frame: at 37 weeks of gestation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2019.
- Individual participant dataSharing planned: No
Related trials for Weight Gain
Recruiting
An Online Intuitive Eating Program for Pregnant Women With Obesity to Support Well-Being
Excessive Gestational Weight Gain, Pregnancy
RecruitingPhase 3
Weight Gain Prevention in Adolescents and Young Adults
Healthy Volunteers
Recruiting
Time Restricted Eating for WeIght LoSs MainTenance-2
Weight Loss, Weight Gain
Enrolling by invitationObservational study
Changes in Body Composition Following Pharmacological Treatment for Obesity.
Obesity (BMI Equal to or >30), Weight Regain After Bariatric Surgery
Recruiting
A Relation Between Craving Induction and Treatment Response in Deep Transcranial Magnetic Stimulation (dTMS) for Reducing Antipsychotic-induced Weight Gain in Schizophrenia
Schizophrenia, Antipsychotic Induced Weight Gain
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.
Assoc. Prof. PD. Nadja Haiden, MD, MSc principal investigator
Medical University of Vienna
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Weight Gain and Human Milk, run by Medical University of Vienna at 2 sites in Austria.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 29 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
growth velocity g/kg/d at 37+0 weeks (time frame: at 37+0 weeks of gestation). 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 29 Apr 2019.