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

NCT ID: NCT02865941

Last Updated: 2016-08-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2019-06-30

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.

Conditions

Postnatal Growth Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

5 milk analysis

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.

Group Type: EXPERIMENTAL

Fortification with modular protein

Intervention Type: DIETARY_SUPPLEMENT

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

Fortification with modular carbohydrate

Intervention Type: DIETARY_SUPPLEMENT

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

Fortification with modular fat

Intervention Type: DIETARY_SUPPLEMENT

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

1 milk analysis

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.

Group Type: EXPERIMENTAL

Fortification with modular protein

Intervention Type: DIETARY_SUPPLEMENT

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

Fortification with modular carbohydrate

Intervention Type: DIETARY_SUPPLEMENT

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

Fortification with modular fat

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Fortification with modular protein

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

Intervention Type: DIETARY_SUPPLEMENT

Fortification with modular carbohydrate

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

Intervention Type: DIETARY_SUPPLEMENT

Fortification with modular fat

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. Gestational age < 30 weeks (maternal dates or early fetal ultrasound);

2. Tolerating an enteral intake of ≥100 mL/kg/d for ≥ 24h;

3. Subject is anticipated to receive the intervention for ≥ 3 consecutive weeks after full enteral feeding (≥150 mL/kg/d) has been achieved;

4. Written informed consent has been obtained from the infant's legal representative.

5. 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.

6. Discussion with Most Responsible Physician (MRP) and the staff in order to discuss any potential transfer during the next 7 days.

Exclusion Criteria

1. Gastrointestinal malformation, major congenital anomalies and chromosomal abnormalities;

2. Babies with enterostoma or short gut syndrome;

3. Infants fed more than 25% of mean caloric intake for a consecutive week with formula milk;

4. Fluid restriction <140 mL/kg/d for ≥ 3 consecutive days;

5. Sepsis - all infants with gram-negative sepsis will be removed from the study;

6. 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);

7. Renal disease, defined by symptoms (oliguria, anuria, proteinuria, hematuria) associated with an increased blood urea nitrogen >10 mmol/L and creatinine of 130mmol/L

8. Participation in another clinical trial that may provide an alternative nutritional intervention, which might affect the outcomes of this study. outcomes of this study;

9. 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)

• Maximum Eligible Age: 29 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McMaster Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Christoph Fusch

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christoph Fusch, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster Children's Hospital

Locations

Faculty of Health Science, McMaster Children's Hospital

Hamilton, Ontario, Canada

Countries

Canada

Central Contacts

Christoph Fusch, MD, PhD

Role: CONTACT

fusch@mcmaster.ca

+1 521 2100 ext. 75721

Niels Rochow, MD

Role: CONTACT

rochow@mcmaster.ca

+1 521 2100 ext. 23106

Facility Contacts

Christoph Fusch, MD, PhD, FRCPC

Role: primary

fusch@mcmaster.ca

+1 905 521 2100 ext. 75721

References

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.

Reference Type: BACKGROUND

PMID: 23769498 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23782538 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22041090 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24912866 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25213193 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25807355 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25835073 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26663457 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26863130 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26927169 (View on PubMed)

Other Identifiers

2016TFO2

Identifier Type: -

Identifier Source: org_study_id