Postnatal Growth DisorderIFONCT01609894
Individualized Fortification of Breast Milk
A study testing Individualized fortification of breast milk and Routine fortification of breast milk in people with Postnatal Growth Disorder and Neurodevelopment, run by McMaster Children's Hospital at 1 site in Canada.
Trial summary
The proposed research will investigate individualized fortification of breast milk based on daily milk analysis of carbohydrate, protein, and fat content in a randomized double blind controlled trial. Read more about this study
- Who is it for?
- Ages Up to 32 weeks
- Conditions the study is for
- Postnatal Growth Disorder, Neurodevelopment
- What is being tested?
- Individualized fortification of breast milk and Routine fortification of breast milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2013to Jun 2018
- 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 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age < 32weeks (maternal dates or early fetal ultrasound);
- Tolerating an enteral intake of ≥ 100 ml/kg/d for ≥ 24h;
- Subject is anticipated to receive the intervention for ≥ 3 consecutive weeks after full enteral feeding (≥ 150 mL/kg/d) has been achieved; and
- Written informed consent has been obtained from the infant's legal representative.
Who cannot join
- Infants with intrauterine growth restriction, small for gestational age defined by a weight less than 3rd percentile using sex specific reference data for birth weight
- Gastrointestinal malformation, major congenital anomalies and chromosomal abnormalities;
- Babies with enterostoma or short gut syndrome;
- Necrotizing enterocolitis, defined by feeding intolerance associated with positive x-ray findings (pneumatosis intestinalis - Bell Stage 2; air in the biliary tract or free air in the peritoneum - Bell Stage 3);
- Renal disease, defined by symptoms (oliguria, anuria, proteinuria, hematuria) associated with an increased blood urea nitrogen 10 mmol/L79 and creatinine of 130 mmol/L80;
- Hepatic dysfunction, defined by jaundice (direct bilirubin >1.0 mg/dl) that is associated with one or more abnormal liver function tests (AST, ALT or GGT);
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- Participation in another clinical trial that may affect outcomes of this study; or
- Probability of transfer to another NICU or level II nursery outside the McMaster Children's Hospital before the minimum period of three weeks is completed.
- Post-randomisation exclusion criteria:
- Infants fed more than 25% of mean caloric intake for a consecutive week with formula milk;
- Fluid restriction < 140mL/kg/d for ≥ 3 consecutive days;
- Sepsis - all infants with gram-negative sepsis will be removed from the study.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Faculty of Health Science, McMaster Children's Hospital
Hamilton, Ontario, L8S 4K1
Christoph Fusch, MD, PhD, FRCPC, +1 905 521 2100 ext. 75721, fusch@mcmaster.ca
Christoph Fusch, MD, PhD, FRCPC
About this study
Official title: Individualized Fortification of Breast Milk With Fat, Carbohydrate and Protein for Preterm Infants
The proposed research will investigate individualized fortification of breast milk based on daily milk analysis of carbohydrate, protein, and fat content in a randomized double blind controlled trial. The combination of additional fat, carbohydrate and protein and commercial fortifier will be added to ensure that the milk contains the target amounts of nutrient. Growth and development of these infants will be compared with that of infants fed mother's milk that has been supplemented with the current standard amounts. The postnatal growth of the infants will be assessed by measuring weight, length and head circumference and fat and lean mass using highly accurate, non-invasive methods throughout the intervention period and at the first follow-up visit after discharge at 3 months. Neurological development will be analyzed at the age of 18 months.
The investigators hypothesize that individualized fortification of breast milk improves the nutritional intake of preterm infants, optimizing growth, and thus this will positively impact neurodevelopment and health.
- Conditions
- Postnatal Growth Disorder, Neurodevelopment
- Being tested
- Individualized fortification of breast milk, Routine fortification of breast milk
- Keywords
- Postnatal development, Breast milk fortification, Composition of breast milk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized fortification of breast milkDietary supplement
Lactose, fat and protein content will be measured prior to breast milk fortification.
Subsequently, breast milk for preterm infants will individually fortified adjusted by using data from milk analysis.
Routine fortification of breast milkDietary supplement
Infants will be fed routine fortified breast milk.
| Study group | Role | What they receive |
|---|---|---|
| Individualized fortification of breast milk | Experimental | 1. Macronutrient content (for protein, carbohydrate and fat content) will be analyzed of native breast milk batches which had been prepared for 24 hr feeding.
2. Routine fortifier will be added to breast milk batches.
3. Modular products for individual adjustment of protein and/or carbohydrate and/or fat will be given in order to achieve target macronutrient level. Receives: Dietary Supplement: Individualized fortification of breast milk |
| Routine fortification of breast milk | Active comparator | 1. Macronutrient content (for protein, carbohydrate and fat content) will be analyzed of native breast milk batches which had been prepared for 24 hr feeding.
2. Routine fortifier will be added to breast milk batches. Receives: Dietary Supplement: Routine fortification of breast milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
growth during first three weeks of intervention
change in body weight gain will be accessed daily.
Measured: first three weeks during intervention before 36 weeks of gestation
Secondary outcomes (12)
enteral energy intake
fat, carbohydrate, protein, and caloric intake by enteral feeding will be assesed daily
Measured: from inclusion at postmentrual age <32 weeks until 36 weeks
neurodevelopment
Bayley Scales of Infant Development III
Measured: at 18 month corrected age
weight gain
change in body weight [g]
Measured: from inclusion at postmentrual age <32 weeks until 18 month corrected age
body length
change in body length [cm]
Measured: from inclusion at postmentrual age <32 weeks until 18 month corrected age
head circumference
change in head circumference [cm]
Measured: from inclusion at postmentrual age <32 weeks until 18 month corrected age
body composition
change in body composition measured with air displacement plethysmography (body weight, body volume, calculated fat and lean mass)
Measured: from inclusion at postmentrual age <32 weeks until 3 month corrected age
body composition (bio-electrical impedance analysis)
change in body composition measured with bio-electrical impedance analysis (impedance at 5, 50, 100 and 200 kHz, resistance at 50 kHz, reactance at 50 kHz, phase angle at 50 kHz)
Measured: from inclusion at postmentrual age <32 weeks until 18 month corrected age
skin fold thickness
change in skin fold thickness [cm]
Measured: from inclusion at postmentrual age <32 weeks until 18 month corrected age
feeding intolerance
occurence of feeding intolerance defined by vomitting, bloody gastric residuals, or abnormal abdomen (tender, discolored, absent bowel sounds)
Measured: during intervention (postmentrual age <32 weeks until 36 weeks)
morbidity
Measured: during intervention (postmentrual age <32 weeks until 36 weeks)
nutrient's blood parameter
triglycerides, glucose, blood urea nitrogen, blood gases, electrolytes, pH
Measured: during intervention (postmentrual age <32 weeks until 36 weeks)
breast milk analysis
using near-infrared analysis breast milk's macronutrients (fat, lactose and protein) will be measured daily
Measured: during intervention (postmentrual age <32 weeks until 36 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2012 (estimated)
- Study startAug 2013
- Primary completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postnatal Growth DisorderStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christoph Fusch, McMaster Children's Hospital
- Investigators
- Christph Fusch, MD, PhD, FRCPC, Principal investigator, McMaster Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01609894
- Sponsor's protocol ID
- 201205IFO
- Acronym
- IFO
- Status last verified
- Aug 2016
- First submitted
- 30 May 2012
- Last updated
- 11 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fabrizio V, Trzaski JM, Brownell EA, Esposito P, Lainwala S, Lussier MM, Hagadorn JI. Individualized versus standard diet fortification for growth and development in preterm infants receiving human milk. Cochrane Database Syst Rev. 2020 Nov 23;11(11):CD013465. doi: 10.1002/14651858.CD013465.pub2.
PubMed 33226632Rochow N, Fusch G, Ali A, Bhatia A, So HY, Iskander R, Chessell L, El Helou S, Fusch C. Individualized target fortification of breast milk with protein, carbohydrates, and fat for preterm infants: A double-blind randomized controlled trial. Clin Nutr. 2021 Jan;40(1):54-63. doi: 10.1016/j.clnu.2020.04.031. Epub 2020 May 6.
PubMed 32446787
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Fortification of Breast Milk With Fat, Carbohydrate and Protein for Preterm Infants
- ClinicalTrials.gov ID
- NCT01609894
- Acronym / sponsor ID
- IFO / 201205IFO
- Conditions
- Postnatal Growth Disorder, Neurodevelopment
- Keywords
- Postnatal development, Breast milk fortification, Composition of breast milk
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- McMaster Children's HospitalUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Jun 2018 (estimated)
- First posted
- 1 Jun 2012 (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 proposed research will investigate individualized fortification of breast milk based on daily milk analysis of carbohydrate, protein, and fat content in a randomized double blind controlled trial. The combination of additional fat, carbohydrate and protein and commercial fortifier will be added to ensure that the milk contains the target amounts of nutrient. Growth and development of these infants will be compared with that of infants fed mother's milk that has been supplemented with the current standard amounts. The postnatal growth of the infants will be assessed by measuring weight, length and head circumference and fat and lean mass using highly accurate, non-invasive methods throughout the intervention period and at the first follow-up visit after discharge at 3 months. Neurological development will be analyzed at the age of 18 months.
The investigators hypothesize that individualized fortification of breast milk improves the nutritional intake of preterm infants, optimizing growth, and thus this will positively impact neurodevelopment and health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individualized fortification of breast milk | Experimental | Dietary Supplement: Individualized fortification of breast milk1. Macronutrient content (for protein, carbohydrate and fat content) will be analyzed of native breast milk batches which had been prepared for 24 hr feeding. 2. Routine fortifier will be added to breast milk batches. 3. Modular products for individual adjustment of protein and/or carbohydrate and/or fat will be given in order to achieve target macronutrient level. |
| Routine fortification of breast milk | Active comparator | Dietary Supplement: Routine fortification of breast milk1. Macronutrient content (for protein, carbohydrate and fat content) will be analyzed of native breast milk batches which had been prepared for 24 hr feeding. 2. Routine fortifier will be added to breast milk batches. |
Who may qualify
- Ages
- Up to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Gestational age < 32weeks (maternal dates or early fetal ultrasound);
- Tolerating an enteral intake of ≥ 100 ml/kg/d for ≥ 24h;
- Subject is anticipated to receive the intervention for ≥ 3 consecutive weeks after full enteral feeding (≥ 150 mL/kg/d) has been achieved; and
- Written informed consent has been obtained from the infant's legal representative.
Key exclusion criteria (12 listed)
- Infants with intrauterine growth restriction, small for gestational age defined by a weight less than 3rd percentile using sex specific reference data for birth weight
- Gastrointestinal malformation, major congenital anomalies and chromosomal abnormalities;
- Babies with enterostoma or short gut syndrome;
- Necrotizing enterocolitis, defined by feeding intolerance associated with positive x-ray findings (pneumatosis intestinalis - Bell Stage 2; air in the biliary tract or free air in the peritoneum - Bell Stage 3);
- Renal disease, defined by symptoms (oliguria, anuria, proteinuria, hematuria) associated with an increased blood urea nitrogen 10 mmol/L79 and creatinine of 130 mmol/L80;
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 |
|---|---|---|
| Individualized fortification of breast milkLactose, fat and protein content will be measured prior to breast milk fortification. Subsequently, breast milk for preterm infants will individually fortified adjusted by using data from milk analysis. | Dietary supplement | Individualized fortification of breast milk |
| Routine fortification of breast milkInfants will be fed routine fortified breast milk. | Dietary supplement | Routine fortification of breast milk |
Primary outcome
growth during first three weeks of intervention
Time frame: first three weeks during intervention before 36 weeks of gestation
change in body weight gain will be accessed daily.
12 secondary outcomes
enteral energy intake
Time frame: from inclusion at postmentrual age <32 weeks until 36 weeks
neurodevelopment
Time frame: at 18 month corrected age
weight gain
Time frame: from inclusion at postmentrual age <32 weeks until 18 month corrected age
body length
Time frame: from inclusion at postmentrual age <32 weeks until 18 month corrected age
head circumference
Time frame: from inclusion at postmentrual age <32 weeks until 18 month corrected age
body composition
Time frame: from inclusion at postmentrual age <32 weeks until 3 month corrected age
body composition (bio-electrical impedance analysis)
Time frame: from inclusion at postmentrual age <32 weeks until 18 month corrected age
skin fold thickness
Time frame: from inclusion at postmentrual age <32 weeks until 18 month corrected age
feeding intolerance
Time frame: during intervention (postmentrual age <32 weeks until 36 weeks)
morbidity
Time frame: during intervention (postmentrual age <32 weeks until 36 weeks)
nutrient's blood parameter
Time frame: during intervention (postmentrual age <32 weeks until 36 weeks)
breast milk analysis
Time frame: during intervention (postmentrual age <32 weeks until 36 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2016.
- Derived from this study: PubMed 33226632Fabrizio V, Trzaski JM, Brownell EA, Esposito P, Lainwala S, Lussier MM, Hagadorn JI. Individualized versus standard diet fortification for growth and development in preterm infants receiving human milk. Cochrane Database Syst Rev. 2020 Nov 23;11(11):CD013465. doi: 10.1002/14651858.CD013465.pub2.
- Derived from this study: PubMed 32446787Rochow N, Fusch G, Ali A, Bhatia A, So HY, Iskander R, Chessell L, El Helou S, Fusch C. Individualized target fortification of breast milk with protein, carbohydrates, and fat for preterm infants: A double-blind randomized controlled trial. Clin Nutr. 2021 Jan;40(1):54-63. doi: 10.1016/j.clnu.2020.04.031. Epub 2020 May 6.
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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.
Christph Fusch, MD, PhD, FRCPC principal investigator
McMaster 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 Individualized fortification of breast milk and Routine fortification of breast milk in people with Postnatal Growth Disorder and Neurodevelopment, run by McMaster Children's Hospital at 1 site in Canada.
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 12 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 11 Aug 2016. 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 Canada. 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 Christoph Fusch, MD, PhD, FRCPC (+1 905 521 2100 ext. 75721, fusch@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
growth during first three weeks of intervention (time frame: first three weeks during intervention before 36 weeks of gestation). 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 NCT01609894, which also lists 2 linked publications.
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 11 Aug 2016.