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Target Fortification of Breast Milk: How Often Breast Milk Needs to be Measured? (TFO2)

Primary Purpose

Postnatal Growth Disorder

Status

Unknown status

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Fortification with modular protein

Fortification with modular carbohydrate

Fortification with modular fat

About this trial

This is an interventional treatment trial for Postnatal Growth Disorder focused on measuring Target Fortification, Breast milk analysis, Nutrition, Macronutrient intake, Protein accretion

Eligibility Criteria

undefined - 29 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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);
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)

Sites / Locations

Faculty of Health Science, McMaster Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

5 milk analysis

1 milk analysis

Arm Description

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. Routine fortifier will be added to breast milk batches. Modular products for individual adjustment of protein and/or carbohydrate and/or fat will be given in order to achieve target macronutrient level.

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. Routine fortifier will be added to breast milk batches. Modular products for individual adjustment of protein and/or carbohydrate and/or fat will be given in order to achieve target macronutrient level.

Outcomes

Primary Outcome Measures

Growth during first three weeks of intervention

Secondary Outcome Measures

Daily Nutrient intake (kcal, lactose, protein, fat) measured with conventional milk analysis

Weight Gain

Oxidative stress by 8-Oxo-2'-deoxyguanosine metabolites in urine

Measured by mass spectroscopy

Protein synthesis analyzed by nitrogen excretion in urine [µmol/mL]

Feeding intolerance questionaire

volume of gastric residuals, color of gastric residuals, vomiting, abdominal girth, abdominal distention

Fat mass [g]

Measured with bioelectrical impedance analysis

Lean mass [g]

Measured with bioelectrical impedance analysis

Head circumference [cm]

Measured by tape

Body length [cm]

Measured by length board

Full Information

NCT ID

NCT02865941

First Posted

August 8, 2016

Last Updated

August 10, 2016

Sponsor

McMaster Children's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02865941

Brief Title

Target Fortification of Breast Milk: How Often Breast Milk Needs to be Measured?

Acronym

TFO2

Official Title

Target Fortification of Breast Milk: The Effect of Different Schedules for Milk Analysis on the Growth and Development of Preterm Infants.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Unknown status

Study Start Date

September 2016 (undefined)

Primary Completion Date

June 2017 (Anticipated)

Study Completion Date

June 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

McMaster Children's Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postnatal Growth Disorder

Keywords

Target Fortification, Breast milk analysis, Nutrition, Macronutrient intake, Protein accretion

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

5 milk analysis

Arm Type

Experimental

Arm Description

Arm Title

1 milk analysis

Arm Type

Experimental

Arm Description

Intervention Type

Dietary Supplement

Intervention Name(s)

Fortification with modular protein

Intervention Description

Modular product supplementation is based on most recent breast analysis done for the participant.

Intervention Type

Dietary Supplement

Intervention Name(s)

Fortification with modular carbohydrate

Intervention Description

Modular product supplementation is based on most recent breast analysis done for the participant.

Intervention Type

Dietary Supplement

Intervention Name(s)

Fortification with modular fat

Intervention Description

Modular product supplementation is based on most recent breast analysis done for the participant.

Primary Outcome Measure Information:

Title

Growth during first three weeks of intervention

Time Frame

first three weeks during intervention before 36 weeks of gestation

Secondary Outcome Measure Information:

Title

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

Title

Weight Gain

Time Frame

from inclusion at postmenstrual age <30 weeks until 36 weeks of gestation or discharge

Title

Oxidative stress by 8-Oxo-2'-deoxyguanosine metabolites in urine

Description

Measured by mass spectroscopy

Time Frame

from inclusion at postmenstrual age <30 weeks until discharge

Title

Protein synthesis analyzed by nitrogen excretion in urine [µmol/mL]

Time Frame

first three weeks during intervention before 36 weeks of gestation

Title

Feeding intolerance questionaire

Description

volume of gastric residuals, color of gastric residuals, vomiting, abdominal girth, abdominal distention

Time Frame

from inclusion at postmenstrual age <30 weeks until discharge

Title

Fat mass [g]

Description

Measured with bioelectrical impedance analysis

Time Frame

from inclusion at postmenstrual age <30 weeks until discharge

Title

Lean mass [g]

Description

Measured with bioelectrical impedance analysis

Time Frame

from inclusion at postmenstrual age <30 weeks until discharge

Title

Head circumference [cm]

Description

Measured by tape

Time Frame

from inclusion at postmenstrual age <30 weeks until discharge

Title

Body length [cm]

Description

Measured by length board

Time Frame

from inclusion at postmenstrual age <30 weeks until discharge

10. Eligibility

Sex

All

Maximum Age & Unit of Time

29 Weeks

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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); 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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Christoph Fusch, MD, PhD

Phone

+1 521 2100

Ext

75721

fusch@mcmaster.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Niels Rochow, MD

Phone

+1 521 2100

Ext

23106

rochow@mcmaster.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christoph Fusch, MD, PhD

Organizational Affiliation

McMaster Children's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Faculty of Health Science, McMaster Children's Hospital

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8S 4K1

Country

Canada

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christoph Fusch, MD, PhD, FRCPC

Phone

+1 905 521 2100

Ext

75721

fusch@mcmaster.ca

First Name & Middle Initial & Last Name & Degree

Christoph Fusch, MD, PhD, FRCPC

First Name & Middle Initial & Last Name & Degree

Niels Rochow, MD

First Name & Middle Initial & Last Name & Degree

Gerhard Fusch, PhD

First Name & Middle Initial & Last Name & Degree

Salhab el Helou, MD, FRCPC

First Name & Middle Initial & Last Name & Degree

Sabiha Ahmad

First Name & Middle Initial & Last Name & Degree

Akshdeep Singh Bhatia

First Name & Middle Initial & Last Name & Degree

Klaus Wutzke, PhD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

23769498

Citation

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.

Results Reference

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PubMed Identifier

23782538

Citation

Choi 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.

Results Reference

background

PubMed Identifier

22041090

Citation

Fusch 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.

Results Reference

background

PubMed Identifier

24912866

Citation

Fusch 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.

Results Reference

background

PubMed Identifier

25213193

Citation

Fusch 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.

Results Reference

background

PubMed Identifier

25807355

Citation

Rochow 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.

Results Reference

background

PubMed Identifier

25835073

Citation

Rochow 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.

Results Reference

background

PubMed Identifier

26663457

Citation

Fusch 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.

Results Reference

background

PubMed Identifier

26863130

Citation

Choi 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.

Results Reference

background

PubMed Identifier

26927169

Citation

Kotrri 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.

Results Reference

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Target Fortification of Breast Milk: How Often Breast Milk Needs to be Measured?

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