Postnatal Growth Failure of Preterm InfantsEarly Phase 1NCT02716337
Target Versus Standard Human Milk Fortification in Very Low Birth Weight Preterm Infants
A Early Phase 1 study testing Addition of human milk fortifiers according to human milk analysis in people with Postnatal Growth Failure of Preterm Infants and Human Milk Fortification, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico.
Trial summary
The prevention of postnatal growth failure in very low birth weight (VLBW) preterm infants is of utmost importance. Standard fortification is the most commonly used supplementation practice but it does not consider the native variability of human milk. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Postnatal Growth Failure of Preterm Infants, Human Milk Fortification
- What is being tested?
- Addition of human milk fortifiers according to human milk analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Mar 2015
- Phase
- Early Phase 1
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Birth weight < 1500 grams
- Gestational age < 32 weeks
- Birth weight > 10th percentile according to Fenton' growth chart
- Exclusively breast feeding during the entire hospital stay
Who cannot join
- Presence of congenital malformations that could affect growth (congenital diseases, chromosomal abnormalities, chronic lung disease, severe brain disease, severe metabolic, cardiac or gastrointestinal diseases)
About this study
The prevention of postnatal growth failure in very low birth weight (VLBW) preterm infants is of utmost importance. Standard fortification is the most commonly used supplementation practice but it does not consider the native variability of human milk. Data on efficacy and safety of prolonged target fortification are scarce. The investigators performed a prospective interventional study in VLBW preterm infants, exclusively fed with human milk, to test efficacy and metabolic safety of target fortification in these preterm infants.
Read the detailed description
The prevention of postnatal growth failure in very low birth weight (VLBW) preterm infants is of utmost importance. Fortified human milk is the goal for preterm infants' nutrition. Standard fortification is the most commonly used and safe supplementation practice but it does not consider the native variability of human milk. Data on efficacy and safety of prolonged target fortification are scarce. Prospective interventional study was conducted in VLBW preterm infants, exclusively fed with human milk. Twenty-four hour collected pools of human milk were analyzed and targeted human milk fortification was performed during hospitalization. Weekly growth and daily growth velocity were compared with that of an historical group of VLBW preterm infants that had received standard fortified human milk. Osmolality, metabolic and gastrointestinal tolerance were monitored.
- Being tested
- Addition of human milk fortifiers according to human milk analysis
- Keywords
- human milk target fortification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Addition of human milk fortifiers according to human milk analysisDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Other | In the intervention group VLBW infants were fed target fortified human milk Growth and safety were compared to a historical group of VLBW infants fed with standard fortified human milk Receives: Dietary Supplement: Addition of human milk fortifiers according to human milk analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily growth velocity (g/kg/day)
Measured: From the beginning of human milk fortification until the end of hospitalization (mean period of treatment 4-5 weeks)
Secondary outcomes (3)
weekly weight increase (g/week)
Measured: From the beginning of human milk fortification until the end of hospitalization (mean period of treatment 4-5 weeks)
weekly length increase (cm/week)
Measured: From the beginning of human milk fortification until the end of hospitalization (mean period of treatment 4-5 weeks)
head circumference increase (cm/week)
Measured: From the beginning of human milk fortification until the end of hospitalization (mean period of treatment 4-5 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2016 (estimated)
- Study startOct 2014
- Primary completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postnatal Growth Failure of Preterm InfantsStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Pier Mannuccio Mannucci, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02716337
- Sponsor's protocol ID
- Target HM fortification
- Status last verified
- Mar 2016
- First submitted
- 7 Mar 2016
- Last updated
- 23 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Morlacchi L, Mallardi D, Gianni ML, Roggero P, Amato O, Piemontese P, Consonni D, Mosca F. Is targeted fortification of human breast milk an optimal nutrition strategy for preterm infants? An interventional study. J Transl Med. 2016 Jul 1;14(1):195. doi: 10.1186/s12967-016-0957-y.
PubMed 27370649
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Target Versus Standard Human Milk Fortification in Very Low Birth Weight Preterm Infants
- ClinicalTrials.gov ID
- NCT02716337
- Acronym / sponsor ID
- Target HM fortification
- Keywords
- human milk target fortification
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Mar 2015 (actual)
- First posted
- 23 Mar 2016 (estimated)
- 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 prevention of postnatal growth failure in very low birth weight (VLBW) preterm infants is of utmost importance. Standard fortification is the most commonly used supplementation practice but it does not consider the native variability of human milk. Data on efficacy and safety of prolonged target fortification are scarce. The investigators performed a prospective interventional study in VLBW preterm infants, exclusively fed with human milk, to test efficacy and metabolic safety of target fortification in these preterm infants.
Detailed description
The prevention of postnatal growth failure in very low birth weight (VLBW) preterm infants is of utmost importance. Fortified human milk is the goal for preterm infants' nutrition. Standard fortification is the most commonly used and safe supplementation practice but it does not consider the native variability of human milk. Data on efficacy and safety of prolonged target fortification are scarce. Prospective interventional study was conducted in VLBW preterm infants, exclusively fed with human milk. Twenty-four hour collected pools of human milk were analyzed and targeted human milk fortification was performed during hospitalization. Weekly growth and daily growth velocity were compared with that of an historical group of VLBW preterm infants that had received standard fortified human milk. Osmolality, metabolic and gastrointestinal tolerance were monitored.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Other | Dietary Supplement: Addition of human milk fortifiers according to human milk analysisIn the intervention group VLBW infants were fed target fortified human milk Growth and safety were compared to a historical group of VLBW infants fed with standard fortified human milk |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Birth weight < 1500 grams
- Gestational age < 32 weeks
- Birth weight > 10th percentile according to Fenton' growth chart
- Exclusively breast feeding during the entire hospital stay
Key exclusion criteria (1 listed)
- Presence of congenital malformations that could affect growth (congenital diseases, chromosomal abnormalities, chronic lung disease, severe brain disease, severe metabolic, cardiac or gastrointestinal diseases)
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 |
|---|---|---|
| Addition of human milk fortifiers according to human milk analysis | Dietary supplement | Intervention group |
Primary outcome
Daily growth velocity (g/kg/day)
Time frame: From the beginning of human milk fortification until the end of hospitalization (mean period of treatment 4-5 weeks)
3 secondary outcomes
weekly weight increase (g/week)
Time frame: From the beginning of human milk fortification until the end of hospitalization (mean period of treatment 4-5 weeks)
weekly length increase (cm/week)
Time frame: From the beginning of human milk fortification until the end of hospitalization (mean period of treatment 4-5 weeks)
head circumference increase (cm/week)
Time frame: From the beginning of human milk fortification until the end of hospitalization (mean period of treatment 4-5 weeks)
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 23 Mar 2016.
- Derived from this study: PubMed 27370649Morlacchi L, Mallardi D, Gianni ML, Roggero P, Amato O, Piemontese P, Consonni D, Mosca F. Is targeted fortification of human breast milk an optimal nutrition strategy for preterm infants? An interventional study. J Transl Med. 2016 Jul 1;14(1):195. doi: 10.1186/s12967-016-0957-y.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Addition of human milk fortifiers according to human milk analysis in people with Postnatal Growth Failure of Preterm Infants and Human Milk Fortification, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico.
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 1 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 23 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Daily growth velocity (g/kg/day) (time frame: From the beginning of human milk fortification until the end of hospitalization (mean period of treatment 4-5 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02716337, which also lists 1 linked publication.
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 23 Mar 2016.