Clinical trial NCT01305642: Individualized Fortification of Breast Milk for Preterm Infants - A Pilot Study
Official title: Individualized Fortification of Breast Milk for Preterm Infants - A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postnatal Growth Disorder
Keywords: Postnatal development
Breast milk fortification
Composition of breast milk
Lead sponsor: McMaster Children's Hospital
Sponsor class: OTHER
First posted: 2011-03-01
Enrollment: 13
Sex: ALL
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: growth
timeFrame: from inclusion at postmentrual age <32 weeks until 36 weeks
Secondary outcomes:
measure: enteral energy intake
timeFrame: from inclusion at postmentrual age <32 weeks until 36 weeks
measure: growth, tolerance, morbidity
timeFrame: from inclusion at postmentrual age <32 weeks until 36 weeks
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster Children's Hospital
state: Ontario
Study officials:
affiliation: McMaster Children's Hospital
name: Christoph Fusch, MD,PhD,FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.