Individualized Fortification of Breast Milk (IFO)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01609894|
Recruitment Status : Unknown
Verified August 2016 by Christoph Fusch, McMaster Children's Hospital.
Recruitment status was: Recruiting
First Posted : June 1, 2012
Last Update Posted : August 11, 2016
The proposed research will investigate individualized fortification of breast milk based on daily milk analysis of carbohydrate, protein, and fat content in a randomized double blind controlled trial. The combination of additional fat, carbohydrate and protein and commercial fortifier will be added to ensure that the milk contains the target amounts of nutrient. Growth and development of these infants will be compared with that of infants fed mother's milk that has been supplemented with the current standard amounts. The postnatal growth of the infants will be assessed by measuring weight, length and head circumference and fat and lean mass using highly accurate, non-invasive methods throughout the intervention period and at the first follow-up visit after discharge at 3 months. Neurological development will be analyzed at the age of 18 months.
The investigators hypothesize that individualized fortification of breast milk improves the nutritional intake of preterm infants, optimizing growth, and thus this will positively impact neurodevelopment and health.
|Condition or disease||Intervention/treatment||Phase|
|Postnatal Growth Disorder Neurodevelopment||Dietary Supplement: Individualized fortification of breast milk Dietary Supplement: Routine fortification of breast milk||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||112 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Individualized Fortification of Breast Milk With Fat, Carbohydrate and Protein for Preterm Infants|
|Study Start Date :||August 2013|
|Estimated Primary Completion Date :||June 2018|
Experimental: Individualized fortification of breast milk
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.
Active Comparator: Routine fortification of breast milk
Dietary Supplement: Routine fortification of breast milk
Infants will be fed routine fortified breast milk.
- growth during first three weeks of intervention [ Time Frame: first three weeks during intervention before 36 weeks of gestation ]change in body weight gain will be accessed daily.
- enteral energy intake [ Time Frame: from inclusion at postmentrual age <32 weeks until 36 weeks ]fat, carbohydrate, protein, and caloric intake by enteral feeding will be assesed daily
- neurodevelopment [ Time Frame: at 18 month corrected age ]Bayley Scales of Infant Development III
- weight gain [ Time Frame: from inclusion at postmentrual age <32 weeks until 18 month corrected age ]change in body weight [g]
- body length [ Time Frame: from inclusion at postmentrual age <32 weeks until 18 month corrected age ]change in body length [cm]
- head circumference [ Time Frame: from inclusion at postmentrual age <32 weeks until 18 month corrected age ]change in head circumference [cm]
- body composition [ Time Frame: from inclusion at postmentrual age <32 weeks until 3 month corrected age ]change in body composition measured with air displacement plethysmography (body weight, body volume, calculated fat and lean mass)
- body composition (bio-electrical impedance analysis) [ Time Frame: from inclusion at postmentrual age <32 weeks until 18 month corrected age ]change in body composition measured with bio-electrical impedance analysis (impedance at 5, 50, 100 and 200 kHz, resistance at 50 kHz, reactance at 50 kHz, phase angle at 50 kHz)
- skin fold thickness [ Time Frame: from inclusion at postmentrual age <32 weeks until 18 month corrected age ]change in skin fold thickness [cm]
- feeding intolerance [ Time Frame: during intervention (postmentrual age <32 weeks until 36 weeks) ]occurence of feeding intolerance defined by vomitting, bloody gastric residuals, or abnormal abdomen (tender, discolored, absent bowel sounds)
- morbidity [ Time Frame: during intervention (postmentrual age <32 weeks until 36 weeks) ]
- nutrient's blood parameter [ Time Frame: during intervention (postmentrual age <32 weeks until 36 weeks) ]triglycerides, glucose, blood urea nitrogen, blood gases, electrolytes, pH
- breast milk analysis [ Time Frame: during intervention (postmentrual age <32 weeks until 36 weeks) ]using near-infrared analysis breast milk's macronutrients (fat, lactose and protein) will be measured daily
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01609894
|Contact: Christoph Fusch, MD, PhD, FRCPC||+1 905 521 2100 ext firstname.lastname@example.org|
|Contact: Niels Rochow, MD||+1 905 521 2100 ext email@example.com|
|Faculty of Health Science, McMaster Children's Hospital||Recruiting|
|Hamilton, Ontario, Canada, L8S 4K1|
|Contact: Christoph Fusch, MD, PhD, FRCPC +1 905 521 2100 ext 75721 firstname.lastname@example.org|
|Principal Investigator: Christoph Fusch, MD, PhD, FRCPC|
|Sub-Investigator: Niels Rochow, MD|
|Sub-Investigator: Gerhard Fusch, PhD|
|Sub-Investigator: Salhab el Helou, MD, FRCPC|
|Sub-Investigator: Sabiha Ahmad|
|Sub-Investigator: Akshdeep Singh Bhatia|
|Sub-Investigator: Klaus Wutzke, PhD|
|Principal Investigator:||Christph Fusch, MD, PhD, FRCPC||McMaster Children's Hospital|