Individualized Fortification of Breast Milk for Preterm Infants - A Pilot Study

Postnatal Growth Disorder Clinical Trial

— IFO Pilot  

Official title:

Individualized Fortification of Breast Milk for Preterm Infants - A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01305642
• Other study ID #: 201101IFOPILOT
• Status: Completed
• Phase: N/A
• First received: February 28, 2011
• Last updated: August 8, 2016
• Start date: February 2011
• Est. completion date: December 2011

Study information

• Verified date: August 2016
• Source: McMaster Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

To analyze the weight gain of very low birth weight infants during a minimum period of three weeks before 36 weeks postmenstrual age when infants are fed with breast milk that has been individually fortified.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: December 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 32 Weeks

Eligibility

Inclusion Criteria:

• Birth weight = 1500g and gestational age < 32weeks

• Tolerating an enteral intake of = 100 ml/kg/d for = 24h

Exclusion Criteria:

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

• gastrointestinal malformation, major congenital anomalies and chromosomal abnormalities

• Babies with enterostoma or short gut syndrome

• Fluid restriction below

• Renal disease

• Sepsis

• Necrotizing enterocolitis

• Hepatic dysfunction

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Growth Disorders
• Postnatal Growth Disorder

Intervention

Dietary Supplement:
• Individualized fortification of breast milk
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.

Locations

Country	Name	City	State
Canada	McMaster Children's Hospital	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
McMaster Children's Hospital

Country where clinical trial is conducted

Canada, 

References & Publications (9)

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

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: 10.1 — 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	weight gain will be accessed three times per week	from inclusion at postmentrual age <32 weeks until 36 weeks	No
Secondary	enteral energy intake	caloric intake by enteral feeding will be assesed daily	from inclusion at postmentrual age <32 weeks until 36 weeks	No
Secondary	growth, tolerance, morbidity	gains in length and head circumference will be assessed weekly, tolerance and morbidity throughout study	from inclusion at postmentrual age <32 weeks until 36 weeks	No