Preterm InfantsNCT05057390
HMF Preterm Case Studies
A study testing New Human Milk Fortifier (NHMF) in people with Preterm Infants, run by Nutricia UK Ltd at 4 sites in United Kingdom.
Trial summary
Nutritional requirements in preterm infants can be elevated, as a result of complex clinical circumstances including infections, immaturity of the gastrointestinal tract and invasive treatments, such as surgery which can place a greater metabolic demand on the body. Read more about this study
- Who is it for?
- Ages Up to 37 weeks
- Conditions the study is for
- Preterm Infants
- What is being tested?
- New Human Milk Fortifier (NHMF)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 16 Dec 2020to 31 Dec 2021
- 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
- Preterm infants fed own mother's milk (or donor human milk) requiring HMF (as decided by the investigator)
- Born before 37 weeks completed gestational age and >1 dropped centile since birth requiring HMF (as decided by the investigator)
- Tolerating adequate volume of enteral nutrition
- Expected to require HMF after discharge (minimum 4.0g NHMF per day at discharge)
- Written or electronic informed consent from parent/caregiver
Who cannot join
- Anticipated short term use of HMF leading to discontinuation of HMF after hospital discharge
- Presence of any relevant proven or suspected chromosomal anomaly or genetic syndrome, any gastrointestinal malformation/compromise, including Necrotising enterocolitis (NEC) (defined as Bell's stage two or higher), metabolic disorder, or congenital central nervous system malformation that may impact tolerance of enteral feeding
- Failure to establish enteral nutrition and requiring full parenteral nutrition
- Participation in other studies within 1 month prior to the entry of this study
- Known allergy to any of the study product ingredients, including cow's milk, fish and egg
- Concern or issues around the breast milk supply from mother of preterm infant at enrolment
- Investigator concerns around willingness/ability of the parent/caregiver to comply with protocol requirements and/or handle and store NHMF appropriately
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Bradford Teaching Hospitals
Bradford
Bristol University Hospitals
Bristol, BS2 8BJ
Norfolk & Norwich University Hospitals
Norwich, NR4 7UY
University Hospitals Plymouth
Plymouth
About this study
Official title: Evaluating the Tolerance, Compliance, Acceptability and Safety of a New Human Milk Fortifier (NHMF) in Preterm Infants: a Case Study Series
Nutritional requirements in preterm infants can be elevated, as a result of complex clinical circumstances including infections, immaturity of the gastrointestinal tract and invasive treatments, such as surgery which can place a greater metabolic demand on the body. Furthermore, these circumstances can impact an infant's ability to meet nutritional requirements and achieve optimum growth through normal feeding alone. Most preterm infants may need specialist care by the neonatal team during hospital admission and post-discharge, which includes enteral nutritional support.
Human Milk Fortifier (HMF) have become a component of the routine clinical care of preterm infants on neonatal units. There is published evidence to support this practice as being safe and effective. A multitude of trials have demonstrated improvements in weight, length and head circumference following interventions using HMF, compared to non-supplemented cohorts, and benefits have been observed at long term follow up.
Read more
Whilst HMF is used routinely in neonatal units, there is little clinical evidence for using them beyond discharge in the community, although this is widely accepted in practice. Nutricia have developed a new HMF (NHMF) that can be provided for use in the community.
This series of case-studies will evaluate the tolerance, compliance, acceptability and safety of the NHMF, in 15 preterm infants. Each case study will last at least 28 days, including at least 7 days in the community setting. The case studies will be conducted across multiple specialist neonatal centres in the UK, to meet the UK ACBS requirements.
- Conditions
- Preterm Infants
- Being tested
- New Human Milk Fortifier (NHMF)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New Human Milk Fortifier (NHMF)Dietary supplement
The case study product will be added to human milk during the hospitalization and will continue after discharge for at least 1 week (7 days), to obtain community data. NHMF prescription will be specified on an individual basis by the investigating Dietitian responsible for the infant's nutritional management. The intervention period will end when the infant does not require NHMF (according to local neonatal guidelines and/or clinical indication).
The case study product will be labelled specifically for the case study and will be available in a powder format.
Full preparation, storage and safety instructions will be given to the parent/caregiver by the investigating Dietitian before commencing the case study product to ensure its correct and safe use.
| Study group | Role | What they receive |
|---|---|---|
| New Human Milk Fortifier | Experimental | From the Baseline (start of intervention) each patient will receive the case study product for at least 4 weeks (28 days), with at least 1-week administration in the community. Receives: Dietary Supplement: New Human Milk Fortifier (NHMF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastro-intestinal tolerance
Gastro-intestinal (GI) tolerance will be recorded by the investigating Dietitian at the above-mentioned time-points. GI tolerance will be recorded using a standardised questionnaire, to be completed by the investigating Dietitian with the parent/caregiver, as appropriate. Parents/caregivers will be asked to recall the infant's symptoms in the past 24 hours to the investigating Dietitian, and as an average over the case study period, at each assessment point.
Measured: Baseline (Start of intervention) - End of case study (4 weeks administration)
Secondary outcomes (3)
Compliance
Compliance with the recommended intake during the case study period will be assessed by the investigating Dietitian at the above-mentioned time-points. The investigating Dietitian will ask parents/caregivers how much case study product was taken by the infant in the past 24 hours and on average over the case study period at each assessment. This will be compared to the amount prescribed by the Dietitian for the infant to consume daily which will be recorded at the start of the case study and any changes during the case study will be noted.
Measured: Baseline (Start of intervention) - End of case study (4 weeks administration)
Anthropometrics
Growth of infants will be determined according to standardised procedures at the above-mentioned time-points. Body weight (grams) will be measured using a weighing scale. Length and head circumference will be measured to the nearest 0.1cm with a length board and non-stretchable tape measure respectively. Growth outputs will be plotted using UK Neonatal and Infant Close Monitoring Growth Charts to track changes over time. Actual growth will be compared to growth expectations set by the investigating Dietitian at the start of the case study (baseline)
Measured: Baseline (Start of intervention) - End of case study (4 weeks administration)
Safety (adverse events)
All adverse events will be recorded throughout the case study
Measured: Baseline (Start of intervention) - End of case study (4 weeks administration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start16 Dec 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm InfantsStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutricia UK Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rebecca Stratton, Study chair, Nutricia UK Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05057390
- Sponsor's protocol ID
- NHMF2020
- Status last verified
- Feb 2022
- First submitted
- 6 Sep 2021
- Last updated
- 17 Feb 2022
- 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 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Tolerance, Compliance, Acceptability and Safety of a New Human Milk Fortifier (NHMF) in Preterm Infants: a Case Study Series
- ClinicalTrials.gov ID
- NCT05057390
- Acronym / sponsor ID
- NHMF2020
- Conditions
- Preterm Infants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Nutricia UK LtdIndustry (pharma, biotech, devices)
- Study start
- 16 Dec 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 27 Sep 2021 (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.
Nutritional requirements in preterm infants can be elevated, as a result of complex clinical circumstances including infections, immaturity of the gastrointestinal tract and invasive treatments, such as surgery which can place a greater metabolic demand on the body. Furthermore, these circumstances can impact an infant's ability to meet nutritional requirements and achieve optimum growth through normal feeding alone. Most preterm infants may need specialist care by the neonatal team during hospital admission and post-discharge, which includes enteral nutritional support.
Human Milk Fortifier (HMF) have become a component of the routine clinical care of preterm infants on neonatal units. There is published evidence to support this practice as being safe and effective. A multitude of trials have demonstrated improvements in weight, length and head circumference following interventions using HMF, compared to non-supplemented cohorts, and benefits have been observed at long term follow up.
Whilst HMF is used routinely in neonatal units, there is little clinical evidence for using them beyond discharge in the community, although this is widely accepted in practice. Nutricia have developed a new HMF (NHMF) that can be provided for use in the community.
This series of case-studies will evaluate the tolerance, compliance, acceptability and safety of the NHMF, in 15 preterm infants. Each case study will last at least 28 days, including at least 7 days in the community setting. The case studies will be conducted across multiple specialist neonatal centres in the UK, to meet the UK ACBS requirements.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| New Human Milk Fortifier | Experimental | Dietary Supplement: New Human Milk Fortifier (NHMF)From the Baseline (start of intervention) each patient will receive the case study product for at least 4 weeks (28 days), with at least 1-week administration in the community. |
Who may qualify
- Ages
- Up to 37 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Preterm infants fed own mother's milk (or donor human milk) requiring HMF (as decided by the investigator)
- Born before 37 weeks completed gestational age and >1 dropped centile since birth requiring HMF (as decided by the investigator)
- Tolerating adequate volume of enteral nutrition
- Expected to require HMF after discharge (minimum 4.0g NHMF per day at discharge)
- Written or electronic informed consent from parent/caregiver
Key exclusion criteria (7 listed)
- Anticipated short term use of HMF leading to discontinuation of HMF after hospital discharge
- Presence of any relevant proven or suspected chromosomal anomaly or genetic syndrome, any gastrointestinal malformation/compromise, including Necrotising enterocolitis (NEC) (defined as Bell's stage two or higher), metabolic disorder, or congenital central nervous system malformation that may impact tolerance of enteral feeding
- Failure to establish enteral nutrition and requiring full parenteral nutrition
- Participation in other studies within 1 month prior to the entry of this study
- Known allergy to any of the study product ingredients, including cow's milk, fish and egg
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 |
|---|---|---|
| New Human Milk Fortifier (NHMF)The case study product will be added to human milk during the hospitalization and will continue after discharge for at least 1 week (7 days), to obtain community data. NHMF prescription will be specified on an individual basis by the investigating Dietitian responsible for the infant's nutritional management. The intervention period will end when the infant does not require NHMF (according to local neonatal guidelines and/or clinical indication). The case study product will be labelled specifically for the case study and will be available in a powder format. Full preparation, storage and safety instructions will be given to the parent/caregiver by the investigating Dietitian before commencing the case study product to ensure its correct and safe use. | Dietary supplement | New Human Milk Fortifier |
Primary outcome
Gastro-intestinal tolerance
Time frame: Baseline (Start of intervention) - End of case study (4 weeks administration)
Gastro-intestinal (GI) tolerance will be recorded by the investigating Dietitian at the above-mentioned time-points. GI tolerance will be recorded using a standardised questionnaire, to be completed by the investigating Dietitian with the parent/caregiver, as appropriate. Parents/caregivers will be asked to recall the infant's symptoms in the past 24 hours to the investigating Dietitian, and as an average over the case study period, at each assessment point.
3 secondary outcomes
Compliance
Time frame: Baseline (Start of intervention) - End of case study (4 weeks administration)
Anthropometrics
Time frame: Baseline (Start of intervention) - End of case study (4 weeks administration)
Safety (adverse events)
Time frame: Baseline (Start of intervention) - End of case study (4 weeks administration)
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 17 Feb 2022.
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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.
Rebecca Stratton study chair
Nutricia UK Ltd
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New Human Milk Fortifier (NHMF) in people with Preterm Infants, run by Nutricia UK Ltd at 4 sites in United Kingdom.
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 5 inclusion and 7 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 17 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. 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?
Gastro-intestinal tolerance (time frame: Baseline (Start of intervention) - End of case study (4 weeks administration)). 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 17 Feb 2022.