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Individualized Fortification of Breast Milk (IFO)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2012 by McMaster Children's Hospital
Sponsor:
Information provided by (Responsible Party):
Christoph Fusch, McMaster Children's Hospital
ClinicalTrials.gov Identifier:
NCT01609894
First received: May 30, 2012
Last updated: June 18, 2012
Last verified: June 2012

May 30, 2012
June 18, 2012
July 2012
June 2016   (final data collection date for primary outcome measure)
growth during first three weeks of intervention [ Time Frame: first three weeks during intervention before 36 weeks of gestation ] [ Designated as safety issue: No ]
change in body weight gain will be accessed daily.
growth [ Time Frame: from inclusion at postmentrual age <32 weeks until 36 weeks ] [ Designated as safety issue: No ]
weight gain will be accessed three times per week
Complete list of historical versions of study NCT01609894 on ClinicalTrials.gov Archive Site
  • enteral energy intake [ Time Frame: from inclusion at postmentrual age <32 weeks until 36 weeks ] [ Designated as safety issue: No ]
    fat, carbohydrate, protein, and caloric intake by enteral feeding will be assesed daily
  • neurodevelopment [ Time Frame: at 18 month corrected age ] [ Designated as safety issue: No ]
    Bayley Scales of Infant Development III
  • weight gain [ Time Frame: from inclusion at postmentrual age <32 weeks until 18 month corrected age ] [ Designated as safety issue: No ]
    change in body weight [g]
  • body length [ Time Frame: from inclusion at postmentrual age <32 weeks until 18 month corrected age ] [ Designated as safety issue: No ]
    change in body length [cm]
  • head circumference [ Time Frame: from inclusion at postmentrual age <32 weeks until 18 month corrected age ] [ Designated as safety issue: No ]
    change in head circumference [cm]
  • body composition [ Time Frame: from inclusion at postmentrual age <32 weeks until 3 month corrected age ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    change in skin fold thickness [cm]
  • feeding intolerance [ Time Frame: during intervention (postmentrual age <32 weeks until 36 weeks) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
  • nutrient's blood parameter [ Time Frame: during intervention (postmentrual age <32 weeks until 36 weeks) ] [ Designated as safety issue: No ]
    triglycerides, glucose, blood urea nitrogen, blood gases, electrolytes, pH
  • breast milk analysis [ Time Frame: during intervention (postmentrual age <32 weeks until 36 weeks) ] [ Designated as safety issue: No ]
    using near-infrared analysis breast milk's macronutrients (fat, lactose and protein) will be measured daily
  • enteral energy intake [ Time Frame: from inclusion at postmentrual age <32 weeks until 36 weeks ] [ Designated as safety issue: No ]
    caloric intake by enteral feeding will be assesed daily
  • neurodevelopment [ Time Frame: at 18month corrected age ] [ Designated as safety issue: No ]
    Bayley Scales of Infant Development III
  • growth, tolerance, morbidity [ Time Frame: from inclusion at postmentrual age <32 weeks until 36 weeks ] [ Designated as safety issue: No ]
    gains in length and head circumference will be assessed weekly, tolerance and morbidity throughout study
Not Provided
Not Provided
 
Individualized Fortification of Breast Milk
Individualized Fortification of Breast Milk With Fat, Carbohydrate and Protein for Preterm Infants

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Postnatal Growth Disorder
  • Neurodevelopment
  • 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.

  • Dietary Supplement: Routine fortification of breast milk
    Infants will be fed routine fortified breast milk.
  • Experimental: Individualized fortification of breast milk
    Intervention: Dietary Supplement: Individualized fortification of breast milk
  • No Intervention: Routine fortification of breast milk
    Intervention: Dietary Supplement: Routine fortification of breast milk
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
112
Not Provided
June 2016   (final data collection date for primary outcome measure)

Inclusion criteria:

  1. Gestational age < 32weeks (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; and
  4. Written informed consent has been obtained from the infant's legal representative.

Exclusion criteria:

  1. Infants with intrauterine growth restriction, small for gestational age defined by a weight less than 3rd percentile using sex specific reference data for birth weight
  2. Gastrointestinal malformation, major congenital anomalies and chromosomal abnormalities;
  3. Babies with enterostoma or short gut syndrome;
  4. 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);
  5. Renal disease, defined by symptoms (oliguria, anuria, proteinuria, hematuria) associated with an increased blood urea nitrogen 10 mmol/L79 and creatinine of 130 mmol/L80;
  6. Hepatic dysfunction, defined by jaundice (direct bilirubin >1.0 mg/dl) that is associated with one or more abnormal liver function tests (AST, ALT or GGT);
  7. Participation in another clinical trial that may affect outcomes of this study; or
  8. Probability of transfer to another NICU or level II nursery outside the McMaster Children's Hospital before the minimum period of three weeks is completed.

Post-randomisation exclusion criteria:

  1. Infants fed more than 25% of mean caloric intake for a consecutive week with formula milk;
  2. Fluid restriction < 140mL/kg/d for ≥ 3 consecutive days;
  3. Sepsis - all infants with gram-negative sepsis will be removed from the study.
Both
up to 32 Weeks
No
Contact: Christoph Fusch, MD, PhD, FRCPC +1 905 521 2100 ext 75721 fusch@mcmaster.ca
Contact: Niels Rochow, MD +1 905 521 2100 ext 23106 rochow@mcmaster.ca
Canada
 
NCT01609894
201205IFO
Yes
Christoph Fusch, McMaster Children's Hospital
McMaster Children's Hospital
Not Provided
Principal Investigator: Christph Fusch, MD, PhD, FRCPC McMaster Children's Hospital
McMaster Children's Hospital
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP