Postnatal Growth DisorderTFO2NCT02865941
Target Fortification of Breast Milk: How Often Breast Milk Needs to be Measured?
A study testing Fortification with modular protein, Fortification with modular carbohydrate and Fortification with modular fat in people with Postnatal Growth Disorder, run by McMaster Children's Hospital at 1 site in Canada.
Trial summary
It has been observed that target fortification on different schedules leads to meal to meal variation. It changes the ratio of protein to energy and the percentage of carbohydrate to non-protein energy which may, affect growth. Read more about this study
- Who is it for?
- Ages Up to 29 weeks
- Conditions the study is for
- Postnatal Growth Disorder
- What is being tested?
- Fortification with modular protein, Fortification with modular carbohydrate and Fortification with modular fat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2016to Jun 2019
- 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 29 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age < 30 weeks (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;
- Written informed consent has been obtained from the infant's legal representative.
- Multiple births: Each infant will be included in the study if he/she meets the study criteria, and siblings will be individually randomized to one or other of the treatment arms.
- Discussion with Most Responsible Physician (MRP) and the staff in order to discuss any potential transfer during the next 7 days.
Who cannot join
- Gastrointestinal malformation, major congenital anomalies and chromosomal abnormalities;
- Babies with enterostoma or short gut syndrome;
- Infants fed more than 25% of mean caloric intake for a consecutive week with formula milk;
- Fluid restriction <140 mL/kg/d for ≥ 3 consecutive days;
- Sepsis - all infants with gram-negative sepsis will be removed from the study;
- 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);
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- Renal disease, defined by symptoms (oliguria, anuria, proteinuria, hematuria) associated with an increased blood urea nitrogen >10 mmol/L and creatinine of 130mmol/L
- Participation in another clinical trial that may provide an alternative nutritional intervention, which might affect the outcomes of this study. outcomes of this study;
- Probability of transfer to another neonatal intensive care unit or level II nursery outside the McMaster Children's Hospital, as discussed with the most responsible physician (MRP)
Trial locations and contacts
1 site in 1 country.
Canada1 site
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: Target Fortification of Breast Milk: The Effect of Different Schedules for Milk Analysis on the Growth and Development of Preterm Infants.
It has been observed that target fortification on different schedules leads to meal to meal variation. It changes the ratio of protein to energy and the percentage of carbohydrate to non-protein energy which may, affect growth. In the past, the investigators have analyzed the outcomes of breast milk composition when target fortification is done with different analysis schedules. The investigators were able to measure the macronutrient intake for different milk analysis schedules via a theoretical model and show that the more frequent schedules reduce the variation of fortified-breast milk, whereas a reduced schedule leads to a high variation of macronutrients. It was observed that, in all the breast milk samples measured twice per week, infants achieved on average the recommended macronutrients in line with current recommendations. Nonetheless, the model only looks at the macronutrient intake and does not investigates the relationship between macronutrient variation and its effect on growth.
The aim of the current study is to compare a frequent schedule of measurement of macronutrient analysis with a reduced schedule of measurement and to study its affect on growth, protein accretion and metabolic parameter.
- Conditions
- Postnatal Growth Disorder
- Being tested
- Fortification with modular protein, Fortification with modular carbohydrate, Fortification with modular fat
- Keywords
- Target Fortification, Breast milk analysis, Nutrition, Macronutrient intake, Protein accretion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fortification with modular proteinDietary supplement
Modular product supplementation is based on most recent breast analysis done for the participant.
Fortification with modular carbohydrateDietary supplement
Modular product supplementation is based on most recent breast analysis done for the participant.
Fortification with modular fatDietary supplement
Modular product supplementation is based on most recent breast analysis done for the participant.
| Study group | Role | What they receive |
|---|---|---|
| 5 milk analysis | Experimental | 1. Macronutrient content (for protein, carbohydrate and fat content) will be analyzed five times per week, of native breast milk batches which had been prepared for 24 hours 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: Fortification with modular protein; Dietary Supplement: Fortification with modular carbohydrate; Dietary Supplement: Fortification with modular fat |
| 1 milk analysis | Experimental | 1. Macronutrient content (for protein, carbohydrate and fat content) will be analyzed once per week of native breast milk batches which had been prepared for 24 hours 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: Fortification with modular protein; Dietary Supplement: Fortification with modular carbohydrate; Dietary Supplement: Fortification with modular fat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth during first three weeks of intervention
Measured: first three weeks during intervention before 36 weeks of gestation
Secondary outcomes (9)
Daily Nutrient intake (kcal, lactose, protein, fat) measured with conventional milk analysis
Measured: from inclusion at postmenstrual age <30 weeks until 36 weeks of gestation
Weight Gain
Measured: from inclusion at postmenstrual age <30 weeks until 36 weeks of gestation or discharge
Oxidative stress by 8-Oxo-2'-deoxyguanosine metabolites in urine
Measured by mass spectroscopy
Measured: from inclusion at postmenstrual age <30 weeks until discharge
Protein synthesis analyzed by nitrogen excretion in urine [µmol/mL]
Measured: first three weeks during intervention before 36 weeks of gestation
Feeding intolerance questionaire
volume of gastric residuals, color of gastric residuals, vomiting, abdominal girth, abdominal distention
Measured: from inclusion at postmenstrual age <30 weeks until discharge
Fat mass [g]
Measured with bioelectrical impedance analysis
Measured: from inclusion at postmenstrual age <30 weeks until discharge
Lean mass [g]
Measured with bioelectrical impedance analysis
Measured: from inclusion at postmenstrual age <30 weeks until discharge
Head circumference [cm]
Measured by tape
Measured: from inclusion at postmenstrual age <30 weeks until discharge
Body length [cm]
Measured by length board
Measured: from inclusion at postmenstrual age <30 weeks until discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionJun 2017 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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
- 56 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
- Christoph Fusch, MD, PhD, Principal investigator, McMaster Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02865941
- Sponsor's protocol ID
- 2016TFO2
- Acronym
- TFO2
- Status last verified
- Aug 2016
- First submitted
- 8 Aug 2016
- Last updated
- 15 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Rochow N, Fusch G, Choi A, Chessell L, Elliott L, McDonald K, Kuiper E, Purcha M, Turner S, Chan E, Xia MY, Fusch C. Target fortification of breast milk with fat, protein, and carbohydrates for preterm infants. J Pediatr. 2013 Oct;163(4):1001-7. doi: 10.1016/j.jpeds.2013.04.052. Epub 2013 Jun 12.
PubMed 23769498Choi A, Fusch G, Rochow N, Sheikh N, Fusch C. Establishment of micromethods for macronutrient contents analysis in breast milk. Matern Child Nutr. 2015 Oct;11(4):761-72. doi: 10.1111/mcn.12053. Epub 2013 Jun 18.
PubMed 23782538Fusch G, Choi A, Rochow N, Fusch C. Quantification of lactose content in human and cow's milk using UPLC-tandem mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci. 2011 Dec 1;879(31):3759-62. doi: 10.1016/j.jchromb.2011.09.053. Epub 2011 Oct 6.
PubMed 22041090Fusch G, Rochow N, Choi A, Fusch S, Poeschl S, Ubah AO, Lee SY, Raja P, Fusch C. Rapid measurement of macronutrients in breast milk: How reliable are infrared milk analyzers? Clin Nutr. 2015 Jun;34(3):465-76. doi: 10.1016/j.clnu.2014.05.005. Epub 2014 May 17.
PubMed 24912866Fusch G, Mitra S, Rochow N, Fusch C. Target fortification of breast milk: levels of fat, protein or lactose are not related. Acta Paediatr. 2015 Jan;104(1):38-42. doi: 10.1111/apa.12804. Epub 2014 Oct 2.
PubMed 25213193Rochow N, Landau-Crangle E, Fusch C. Challenges in breast milk fortification for preterm infants. Curr Opin Clin Nutr Metab Care. 2015 May;18(3):276-84. doi: 10.1097/MCO.0000000000000167.
PubMed 25807355Rochow N, Fusch G, Zapanta B, Ali A, Barui S, Fusch C. Target fortification of breast milk: how often should milk analysis be done? Nutrients. 2015 Apr 1;7(4):2297-310. doi: 10.3390/nu7042297.
PubMed 25835073Fusch G, Kwan C, Huang RC, Rochow N, Fusch C. Need of quality control programme when using near-infrared human milk analyzers. Acta Paediatr. 2016 Mar;105(3):324-5. doi: 10.1111/apa.13305. Epub 2016 Jan 19. No abstract available.
PubMed 26663457Choi A, Fusch G, Rochow N, Fusch C. Target Fortification of Breast Milk: Predicting the Final Osmolality of the Feeds. PLoS One. 2016 Feb 10;11(2):e0148941. doi: 10.1371/journal.pone.0148941. eCollection 2016.
PubMed 26863130Kotrri G, Fusch G, Kwan C, Choi D, Choi A, Al Kafi N, Rochow N, Fusch C. Validation of Correction Algorithms for Near-IR Analysis of Human Milk in an Independent Sample Set-Effect of Pasteurization. Nutrients. 2016 Feb 26;8(3):119. doi: 10.3390/nu8030119.
PubMed 26927169
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Target Fortification of Breast Milk: The Effect of Different Schedules for Milk Analysis on the Growth and Development of Preterm Infants.
- ClinicalTrials.gov ID
- NCT02865941
- Acronym / sponsor ID
- TFO2 / 2016TFO2
- Conditions
- Postnatal Growth Disorder
- Keywords
- Target Fortification, Breast milk analysis, Nutrition, Macronutrient intake, Protein accretion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- McMaster Children's HospitalUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 15 Aug 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.
It has been observed that target fortification on different schedules leads to meal to meal variation. It changes the ratio of protein to energy and the percentage of carbohydrate to non-protein energy which may, affect growth. In the past, the investigators have analyzed the outcomes of breast milk composition when target fortification is done with different analysis schedules. The investigators were able to measure the macronutrient intake for different milk analysis schedules via a theoretical model and show that the more frequent schedules reduce the variation of fortified-breast milk, whereas a reduced schedule leads to a high variation of macronutrients. It was observed that, in all the breast milk samples measured twice per week, infants achieved on average the recommended macronutrients in line with current recommendations. Nonetheless, the model only looks at the macronutrient intake and does not investigates the relationship between macronutrient variation and its effect on growth.
The aim of the current study is to compare a frequent schedule of measurement of macronutrient analysis with a reduced schedule of measurement and to study its affect on growth, protein accretion and metabolic parameter.
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 |
|---|---|---|
| 5 milk analysis | Experimental | Dietary Supplement: Fortification with modular protein, Dietary Supplement: Fortification with modular carbohydrate, Dietary Supplement: Fortification with modular fat1. Macronutrient content (for protein, carbohydrate and fat content) will be analyzed five times per week, of native breast milk batches which had been prepared for 24 hours 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. |
| 1 milk analysis | Experimental | Dietary Supplement: Fortification with modular protein, Dietary Supplement: Fortification with modular carbohydrate, Dietary Supplement: Fortification with modular fat1. Macronutrient content (for protein, carbohydrate and fat content) will be analyzed once per week of native breast milk batches which had been prepared for 24 hours 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. |
Who may qualify
- Ages
- Up to 29 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Gestational age < 30 weeks (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;
- Written informed consent has been obtained from the infant's legal representative.
- Multiple births: Each infant will be included in the study if he/she meets the study criteria, and siblings will be individually randomized to one or other of the treatment arms.
Key exclusion criteria (9 listed)
- Gastrointestinal malformation, major congenital anomalies and chromosomal abnormalities;
- Babies with enterostoma or short gut syndrome;
- Infants fed more than 25% of mean caloric intake for a consecutive week with formula milk;
- Fluid restriction <140 mL/kg/d for ≥ 3 consecutive days;
- Sepsis - all infants with gram-negative sepsis will be removed from the study;
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 |
|---|---|---|
| Fortification with modular proteinModular product supplementation is based on most recent breast analysis done for the participant. | Dietary supplement | 1 milk analysis, 5 milk analysis |
| Fortification with modular carbohydrateModular product supplementation is based on most recent breast analysis done for the participant. | Dietary supplement | 1 milk analysis, 5 milk analysis |
| Fortification with modular fatModular product supplementation is based on most recent breast analysis done for the participant. | Dietary supplement | 1 milk analysis, 5 milk analysis |
Primary outcome
Growth during first three weeks of intervention
Time frame: first three weeks during intervention before 36 weeks of gestation
9 secondary outcomes
Daily Nutrient intake (kcal, lactose, protein, fat) measured with conventional milk analysis
Time frame: from inclusion at postmenstrual age <30 weeks until 36 weeks of gestation
Weight Gain
Time frame: from inclusion at postmenstrual age <30 weeks until 36 weeks of gestation or discharge
Oxidative stress by 8-Oxo-2'-deoxyguanosine metabolites in urine
Time frame: from inclusion at postmenstrual age <30 weeks until discharge
Protein synthesis analyzed by nitrogen excretion in urine [µmol/mL]
Time frame: first three weeks during intervention before 36 weeks of gestation
Feeding intolerance questionaire
Time frame: from inclusion at postmenstrual age <30 weeks until discharge
Fat mass [g]
Time frame: from inclusion at postmenstrual age <30 weeks until discharge
Lean mass [g]
Time frame: from inclusion at postmenstrual age <30 weeks until discharge
Head circumference [cm]
Time frame: from inclusion at postmenstrual age <30 weeks until discharge
Body length [cm]
Time frame: from inclusion at postmenstrual age <30 weeks until discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2016.
- Background: PubMed 23769498Rochow N, Fusch G, Choi A, Chessell L, Elliott L, McDonald K, Kuiper E, Purcha M, Turner S, Chan E, Xia MY, Fusch C. Target fortification of breast milk with fat, protein, and carbohydrates for preterm infants. J Pediatr. 2013 Oct;163(4):1001-7. doi: 10.1016/j.jpeds.2013.04.052. Epub 2013 Jun 12.
- Background: PubMed 23782538Choi A, Fusch G, Rochow N, Sheikh N, Fusch C. Establishment of micromethods for macronutrient contents analysis in breast milk. Matern Child Nutr. 2015 Oct;11(4):761-72. doi: 10.1111/mcn.12053. Epub 2013 Jun 18.
- Background: PubMed 22041090Fusch G, Choi A, Rochow N, Fusch C. Quantification of lactose content in human and cow's milk using UPLC-tandem mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci. 2011 Dec 1;879(31):3759-62. doi: 10.1016/j.jchromb.2011.09.053. Epub 2011 Oct 6.
- Background: PubMed 24912866Fusch G, Rochow N, Choi A, Fusch S, Poeschl S, Ubah AO, Lee SY, Raja P, Fusch C. Rapid measurement of macronutrients in breast milk: How reliable are infrared milk analyzers? Clin Nutr. 2015 Jun;34(3):465-76. doi: 10.1016/j.clnu.2014.05.005. Epub 2014 May 17.
- Background: PubMed 25213193Fusch G, Mitra S, Rochow N, Fusch C. Target fortification of breast milk: levels of fat, protein or lactose are not related. Acta Paediatr. 2015 Jan;104(1):38-42. doi: 10.1111/apa.12804. Epub 2014 Oct 2.
- Background: PubMed 25807355Rochow N, Landau-Crangle E, Fusch C. Challenges in breast milk fortification for preterm infants. Curr Opin Clin Nutr Metab Care. 2015 May;18(3):276-84. doi: 10.1097/MCO.0000000000000167.
- Background: PubMed 25835073Rochow N, Fusch G, Zapanta B, Ali A, Barui S, Fusch C. Target fortification of breast milk: how often should milk analysis be done? Nutrients. 2015 Apr 1;7(4):2297-310. doi: 10.3390/nu7042297.
- Background: PubMed 26663457Fusch G, Kwan C, Huang RC, Rochow N, Fusch C. Need of quality control programme when using near-infrared human milk analyzers. Acta Paediatr. 2016 Mar;105(3):324-5. doi: 10.1111/apa.13305. Epub 2016 Jan 19. No abstract available.
- Background: PubMed 26863130Choi A, Fusch G, Rochow N, Fusch C. Target Fortification of Breast Milk: Predicting the Final Osmolality of the Feeds. PLoS One. 2016 Feb 10;11(2):e0148941. doi: 10.1371/journal.pone.0148941. eCollection 2016.
- Background: PubMed 26927169Kotrri G, Fusch G, Kwan C, Choi D, Choi A, Al Kafi N, Rochow N, Fusch C. Validation of Correction Algorithms for Near-IR Analysis of Human Milk in an Independent Sample Set-Effect of Pasteurization. Nutrients. 2016 Feb 26;8(3):119. doi: 10.3390/nu8030119.
- 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.
Christoph Fusch, MD, PhD 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 Fortification with modular protein, Fortification with modular carbohydrate and Fortification with modular fat in people with Postnatal Growth Disorder, 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 6 inclusion and 9 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 15 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 (+1 521 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 NCT02865941, which also lists 10 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 15 Aug 2016.