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
  Purpose

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 Intervention
Postnatal Growth Disorder
Neurodevelopment
Dietary Supplement: Individualized fortification of breast milk
Dietary Supplement: Routine fortification of breast milk

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Individualized Fortification of Breast Milk With Fat, Carbohydrate and Protein for Preterm Infants

Resource links provided by NLM:


Further study details as provided by McMaster Children's Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 112
Study Start Date: July 2012
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

No Intervention: Routine fortification of breast milk Dietary Supplement: Routine fortification of breast milk
Infants will be fed routine fortified breast milk.

  Eligibility

Ages Eligible for Study:   up to 32 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01609894

Contacts
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

Locations
Canada, Ontario
Faculty of Health Science, McMaster Children's Hospital Not yet recruiting
Hamilton, Ontario, Canada, L8S 4K1
Contact: Christoph Fusch, MD, PhD, FRCPC    +1 905 521 2100 ext 75721    fusch@mcmaster.ca   
Principal Investigator: Christoph Fusch, MD, PhD, FRCPC         
Sub-Investigator: Niels Rochow, MD         
Sub-Investigator: Gerhard Fusch, PhD         
Sub-Investigator: Lorraine Chessell         
Sub-Investigator: Salhab el Halou, MD, FRCPC         
Sponsors and Collaborators
McMaster Children's Hospital
Investigators
Principal Investigator: Christph Fusch, MD, PhD, FRCPC McMaster Children's Hospital
  More Information

No publications provided

Responsible Party: Christoph Fusch, Professor and Division Head, McMaster Children's Hospital
ClinicalTrials.gov Identifier: NCT01609894     History of Changes
Other Study ID Numbers: 201205IFO
Study First Received: May 30, 2012
Last Updated: June 18, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster Children's Hospital:
Postnatal development
Breast milk fortification
Composition of breast milk

Additional relevant MeSH terms:
Growth Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on July 20, 2014