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

Postnatal Growth Disorder Clinical Trial

— TFO2  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02865941
• Other study ID #: 2016TFO2
• Status: Not yet recruiting
• Phase: N/A
• First received: August 8, 2016
• Last updated: August 10, 2016
• Start date: September 2016
• Est. completion date: June 2019

Study information

• Verified date: August 2016
• Source: McMaster Children's Hospital
• Contact: Christoph Fusch, MD, PhD
• Phone: +1 521 2100
• Email: fusch[@]mcmaster.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 56
• Est. completion date: June 2019
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 29 Weeks

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Growth Disorders
• Postnatal Growth Disorder

Intervention

Dietary Supplement:
• Fortification with modular protein
Modular product supplementation is based on most recent breast analysis done for the participant.
• Fortification with modular carbohydrate
Modular product supplementation is based on most recent breast analysis done for the participant.
• Fortification with modular fat
Modular product supplementation is based on most recent breast analysis done for the participant.

Locations

Country	Name	City	State
Canada	Faculty of Health Science, McMaster Children's Hospital	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
McMaster Children's Hospital

Country where clinical trial is conducted

Canada, 

References & Publications (10)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Growth during first three weeks of intervention		first three weeks during intervention before 36 weeks of gestation	No
Secondary	Daily Nutrient intake (kcal, lactose, protein, fat) measured with conventional milk analysis		from inclusion at postmenstrual age <30 weeks until 36 weeks of gestation	No
Secondary	Weight Gain		from inclusion at postmenstrual age <30 weeks until 36 weeks of gestation or discharge	No
Secondary	Oxidative stress by 8-Oxo-2'-deoxyguanosine metabolites in urine	Measured by mass spectroscopy	from inclusion at postmenstrual age <30 weeks until discharge	No
Secondary	Protein synthesis analyzed by nitrogen excretion in urine [µmol/mL]		first three weeks during intervention before 36 weeks of gestation	No
Secondary	Feeding intolerance questionaire	volume of gastric residuals, color of gastric residuals, vomiting, abdominal girth, abdominal distention	from inclusion at postmenstrual age <30 weeks until discharge	No
Secondary	Fat mass [g]	Measured with bioelectrical impedance analysis	from inclusion at postmenstrual age <30 weeks until discharge	No
Secondary	Lean mass [g]	Measured with bioelectrical impedance analysis	from inclusion at postmenstrual age <30 weeks until discharge	No
Secondary	Head circumference [cm]	Measured by tape	from inclusion at postmenstrual age <30 weeks until discharge	No
Secondary	Body length [cm]	Measured by length board	from inclusion at postmenstrual age <30 weeks until discharge	No