Very Low Birth Weight InfantNCT04640805
Targeted Fortification of Pasteurized Donor Human Milk
A study testing Protein supplementation and Analysis with Miris Human Milk Analyzer in people with Very Low Birth Weight Infant and Growth Failure, run by KK Women's and Children's Hospital at 1 site in Singapore.
Trial summary
This randomized controlled trial aims to evaluate a modified targeted fortification method of pasteurized donor human milk (PDHM) in very low birth weight infants (VLBWs). Pools of PDHM will be analyzed for macronutrient content using the Miris Human Milk Analyzer. Read more about this study
- Who is it for?
- Ages Up to 37 weeks
- Conditions the study is for
- Very Low Birth Weight Infant, Growth Failure, Donor Breast Milk
- What is being tested?
- Protein supplementation and Analysis with Miris Human Milk Analyzer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Mar 2021to 1 Dec 2025
- 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 Up to 37 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Birth weight less than or equal to 1500g
- Born at our study hospital or transferred to study hospital within first week of life
- Achieving at least 40ml/kg/day of enteral feeds by day 7 of life
- Receiving at least 25% of pasteurized donor human milk within first 7 days of life
Who cannot join
- Diagnosed or suspected inborn errors of metabolism
- Acute or chronic renal impairment
- Congenital disease associated with significant growth impairment (including, but not limited to, Trisomy 21, neonatal encephalopathy and seizures, neonatal tumours, achondroplasia, complex congenital heart disease, anorectal malformations, gastrointestinal disorders)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Targeted Fortification of Pasteurized Donor Human Milk to Improve Growth in Very Low Birth Weight Infants
This randomized controlled trial aims to evaluate a modified targeted fortification method of pasteurized donor human milk (PDHM) in very low birth weight infants (VLBWs). Pools of PDHM will be analyzed for macronutrient content using the Miris Human Milk Analyzer. The control arm will receive standard of care, which is PDHM without additional protein fortification. The intervention arm will receive PDHM with a fat content of 3.8g/dL or more, with additional protein fortification of 0.67g/dL. Primary outcome will be rate of malnutrition at hospital discharge or 37 weeks, whichever earlier. Secondary outcomes include body composition, feed tolerance, and morbidity outcomes.
Read the detailed description
Our hospital milk bank provides pasteurized donor human milk (PDHM) to very low birth weight (VLBW) infants without sufficient mother's milk, with the overall aim of lowering the risk of necrotizing enterocolitis in this population. However, with the introduction of PDHM in our setting, rates of suboptimal weight gain have increased (60.2% to 65.7%). This is likely due to the fact that PDHM is often lower in energy and protein than preterm mother's own milk. One solution to delivery adequate nutrition in this VLBWs receiving PDHM, is targeted fortification, which involves measurement of the macronutrient content of human milk, and adding extra macronutrients to reach nutrient goals. In this proposed study, we will conduct a pilot randomized controlled trial of a modified targeted fortification versus standard care. This study will include preterm VLBW infants (<1500g), without congenital conditions resulting in growth restriction, and receiving >25% of PDHM use in the first week of life. 40 patients in each arm will be recruited over a period of 2 years. The intervention group will receive a modified targeted fortification, consisting of selection of high fat PDHM (3.8g/dL or more) with the addition of protein fortification of 0.67g/dL from week 2 of life until a gestational age of 37 weeks or hospital discharge, whichever earlier. The control group will receive usual regular PDHM with standard fortification using human milk fortifier as per current practice. The primary outcome is the rate of suboptimal growth (drop in weight z-score from birth ≥0.8) at discharge or 37 weeks. Secondary outcomes include body composition, feed tolerance, and morbidity outcomes.
- Being tested
- Protein supplementation, Analysis with Miris Human Milk Analyzer
- Medical subject headings
- Failure to Thrive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein supplementationDietary supplement
Liquid protein fortifier (Similac) will be added at 1ml per 25ml of PDHM at 130ml/kg/day of feed volume.
Analysis with Miris Human Milk AnalyzerOther
PDHM macronutrient content will be analyzed using the Miris Human Milk Analyzer and PDHM with fat content of 3.8g/dL or higher will be selected and provided.
| Study group | Role | What they receive |
|---|---|---|
| Control group (standard fortification) | No intervention | Pasteurized Donor Human Milk (PDHM) will be fortified as per unit protocols, at 1 packet of Human Milk Fortifier (Similac or Pre-Nan) to every 25ml PDHM at a feed volume of 80ml/kg/day |
| Intervention group (modified targeted fortification) | Experimental | Pasteurized Donor Human Milk (PDHM) will be analyzed using the Miris Human Milk Analyzer, and PDHM with a fat content of 3.8g/dL or higher will be selected. Additional protein will be added using liquid protein fortifier (Similac) at 1ml to every 25ml PDHM to give an additional 0.67g/dL protein. Receives: Dietary Supplement: Protein supplementation; Other: Analysis with Miris Human Milk Analyzer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Malnutrition rate
Malnutrition is defined as a decline in weight z-score from birth of 0.8 or more
Measured: Hospital discharge or 37 weeks gestation, whichever earlier
Secondary outcomes (6)
Linear growth
Linear growth will be assessed using z-score changes from birth
Measured: Hospital discharge or 37 weeks post menstrual age, whichever earlier
Body composition
Percent fat mass and fat-free mass measured using air displacement plethysmography
Measured: Hospital discharge or 37 weeks gestation, whichever earlier
Head circumference growth
Head circumference will be assessed using z-score changes from birth
Measured: Hospital discharge or 37 weeks gestation, whichever earlier
High calorie formula use
Proportion of high calorie formula use (e.g. 27kcal/oz or 30kcal/oz formula)
Measured: Hospital discharge or 35 weeks gestation, whichever earlier
Bronchopulmonary dysplasia
Proportion of patients with bronchopulmonary dysplasia
Measured: Hospital discharge or 37 weeks gestation, whichever earlier
Retinopathy of prematurity
Proportion of patients with retinopathy of prematurity
Measured: Hospital discharge or 37 weeks gestation, whichever earlier
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start1 Mar 2021
- Primary completion21 Sep 2023
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Very Low Birth Weight InfantStudies of the same condition, open and under way.
- More trials run by KK Women's and Children's HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Assignment to study group will be done in a 1:1 ratio. Twins/triplets will be randomized to the same group.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Chengsi Ong, Principal investigator, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04640805
- Sponsor's protocol ID
- 2020/2493
- Status last verified
- Oct 2024
- First submitted
- 10 Nov 2020
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Fortification of Pasteurized Donor Human Milk to Improve Growth in Very Low Birth Weight Infants
- ClinicalTrials.gov ID
- NCT04640805
- Acronym / sponsor ID
- 2020/2493
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 61 participants (actual)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 21 Sep 2023 (actual)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 23 Nov 2020 (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.
This randomized controlled trial aims to evaluate a modified targeted fortification method of pasteurized donor human milk (PDHM) in very low birth weight infants (VLBWs). Pools of PDHM will be analyzed for macronutrient content using the Miris Human Milk Analyzer. The control arm will receive standard of care, which is PDHM without additional protein fortification. The intervention arm will receive PDHM with a fat content of 3.8g/dL or more, with additional protein fortification of 0.67g/dL. Primary outcome will be rate of malnutrition at hospital discharge or 37 weeks, whichever earlier. Secondary outcomes include body composition, feed tolerance, and morbidity outcomes.
Detailed description
Our hospital milk bank provides pasteurized donor human milk (PDHM) to very low birth weight (VLBW) infants without sufficient mother's milk, with the overall aim of lowering the risk of necrotizing enterocolitis in this population. However, with the introduction of PDHM in our setting, rates of suboptimal weight gain have increased (60.2% to 65.7%). This is likely due to the fact that PDHM is often lower in energy and protein than preterm mother's own milk. One solution to delivery adequate nutrition in this VLBWs receiving PDHM, is targeted fortification, which involves measurement of the macronutrient content of human milk, and adding extra macronutrients to reach nutrient goals. In this proposed study, we will conduct a pilot randomized controlled trial of a modified targeted fortification versus standard care. This study will include preterm VLBW infants (<1500g), without congenital conditions resulting in growth restriction, and receiving >25% of PDHM use in the first week of life. 40 patients in each arm will be recruited over a period of 2 years. The intervention group will receive a modified targeted fortification, consisting of selection of high fat PDHM (3.8g/dL or more) with the addition of protein fortification of 0.67g/dL from week 2 of life until a gestational age of 37 weeks or hospital discharge, whichever earlier. The control group will receive usual regular PDHM with standard fortification using human milk fortifier as per current practice. The primary outcome is the rate of suboptimal growth (drop in weight z-score from birth ≥0.8) at discharge or 37 weeks. Secondary outcomes include body composition, feed tolerance, and morbidity outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Assignment to study group will be done in a 1:1 ratio. Twins/triplets will be randomized to the same group.
| Arm | Type | Receives |
|---|---|---|
| Control group (standard fortification) | No intervention | –Pasteurized Donor Human Milk (PDHM) will be fortified as per unit protocols, at 1 packet of Human Milk Fortifier (Similac or Pre-Nan) to every 25ml PDHM at a feed volume of 80ml/kg/day |
| Intervention group (modified targeted fortification) | Experimental | Dietary Supplement: Protein supplementation, Other: Analysis with Miris Human Milk AnalyzerPasteurized Donor Human Milk (PDHM) will be analyzed using the Miris Human Milk Analyzer, and PDHM with a fat content of 3.8g/dL or higher will be selected. Additional protein will be added using liquid protein fortifier (Similac) at 1ml to every 25ml PDHM to give an additional 0.67g/dL protein. |
Who may qualify
- Ages
- Up to 37 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Birth weight less than or equal to 1500g
- Born at our study hospital or transferred to study hospital within first week of life
- Achieving at least 40ml/kg/day of enteral feeds by day 7 of life
- Receiving at least 25% of pasteurized donor human milk within first 7 days of life
Key exclusion criteria (3 listed)
- Diagnosed or suspected inborn errors of metabolism
- Acute or chronic renal impairment
- Congenital disease associated with significant growth impairment (including, but not limited to, Trisomy 21, neonatal encephalopathy and seizures, neonatal tumours, achondroplasia, complex congenital heart disease, anorectal malformations, gastrointestinal disorders)
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 |
|---|---|---|
| Protein supplementationLiquid protein fortifier (Similac) will be added at 1ml per 25ml of PDHM at 130ml/kg/day of feed volume. | Dietary supplement | Intervention group (modified targeted fortification) |
| Analysis with Miris Human Milk AnalyzerPDHM macronutrient content will be analyzed using the Miris Human Milk Analyzer and PDHM with fat content of 3.8g/dL or higher will be selected and provided. | Other | Intervention group (modified targeted fortification) |
Primary outcome
Malnutrition rate
Time frame: Hospital discharge or 37 weeks gestation, whichever earlier
Malnutrition is defined as a decline in weight z-score from birth of 0.8 or more
6 secondary outcomes
Linear growth
Time frame: Hospital discharge or 37 weeks post menstrual age, whichever earlier
Body composition
Time frame: Hospital discharge or 37 weeks gestation, whichever earlier
Head circumference growth
Time frame: Hospital discharge or 37 weeks gestation, whichever earlier
High calorie formula use
Time frame: Hospital discharge or 35 weeks gestation, whichever earlier
Bronchopulmonary dysplasia
Time frame: Hospital discharge or 37 weeks gestation, whichever earlier
Retinopathy of prematurity
Time frame: Hospital discharge or 37 weeks gestation, whichever earlier
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
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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.
Chengsi Ong principal investigator
KK Women's and Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein supplementation and Analysis with Miris Human Milk Analyzer in people with Very Low Birth Weight Infant and Growth Failure, run by KK Women's and Children's Hospital at 1 site in Singapore.
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 4 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: status not confirmed, as of the sponsor's last update on 10 Oct 2024. 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 Singapore. 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?
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?
Malnutrition rate (time frame: Hospital discharge or 37 weeks gestation, whichever earlier). 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 10 Oct 2024.