Individualized Fortification of Breast Milk

NCT01609894 | Unknown DMC

• 1 other identifier: 201205IFO
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postnatal Growth Disorder; Neurodevelopment

Keywords

Postnatal development; Breast milk fortification; Composition of breast milk

Outcome Measures

Primary Outcomes (1)

• growth during first three weeks of intervention

  change in body weight gain will be accessed daily.

  first three weeks during intervention before 36 weeks of gestation

Secondary Outcomes (12)

• enteral energy intake

  from inclusion at postmentrual age <32 weeks until 36 weeks

• neurodevelopment

  at 18 month corrected age

• weight gain

  from inclusion at postmentrual age <32 weeks until 18 month corrected age

• body length

  from inclusion at postmentrual age <32 weeks until 18 month corrected age

• head circumference

  from inclusion at postmentrual age <32 weeks until 18 month corrected age

Study Arms (2)

Individualized fortification of breast milk

EXPERIMENTAL

1. Macronutrient content (for protein, carbohydrate and fat content) will be analyzed of native breast milk batches which had been prepared for 24 hr feeding. 2. Routine fortifier will be added to breast milk batches. 3. Modular products for individual adjustment of protein and/or carbohydrate and/or fat will be given in order to achieve target macronutrient level.

Dietary Supplement: Individualized fortification of breast milk

Routine fortification of breast milk

ACTIVE COMPARATOR

1. Macronutrient content (for protein, carbohydrate and fat content) will be analyzed of native breast milk batches which had been prepared for 24 hr feeding. 2. Routine fortifier will be added to breast milk batches.

Dietary Supplement: Routine fortification of breast milk

Interventions

Individualized fortification of breast milk DIETARY_SUPPLEMENT

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.

Individualized fortification of breast milk

Routine fortification of breast milk DIETARY_SUPPLEMENT

Infants will be fed routine fortified breast milk.

Routine fortification of breast milk

Eligibility Criteria

• Age: Up to 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Gestational age \< 32weeks (maternal dates or early fetal ultrasound);
• Tolerating an enteral intake of ≥ 100 ml/kg/d for ≥ 24h;
• Subject is anticipated to receive the intervention for ≥ 3 consecutive weeks after full enteral feeding (≥ 150 mL/kg/d) has been achieved; and
• Written informed consent has been obtained from the infant's legal representative.

You may not qualify if:

• 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
• Gastrointestinal malformation, major congenital anomalies and chromosomal abnormalities;
• Babies with enterostoma or short gut syndrome;
• 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);
• 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;
• 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);
• Participation in another clinical trial that may affect outcomes of this study; or
• 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.
• Infants fed more than 25% of mean caloric intake for a consecutive week with formula milk;
• Fluid restriction \< 140mL/kg/d for ≥ 3 consecutive days;
• Sepsis - all infants with gram-negative sepsis will be removed from the study.

Sponsors & Collaborators

• McMaster Children's Hospital: lead

Study Sites (1)

Faculty of Health Science, McMaster Children's Hospital

Hamilton, Ontario, L8S 4K1, Canada

RECRUITING

Related Publications (2)

• Fabrizio V, Trzaski JM, Brownell EA, Esposito P, Lainwala S, Lussier MM, Hagadorn JI. Individualized versus standard diet fortification for growth and development in preterm infants receiving human milk. Cochrane Database Syst Rev. 2020 Nov 23;11(11):CD013465. doi: 10.1002/14651858.CD013465.pub2.

  PMID: 33226632 DERIVED

• Rochow N, Fusch G, Ali A, Bhatia A, So HY, Iskander R, Chessell L, El Helou S, Fusch C. Individualized target fortification of breast milk with protein, carbohydrates, and fat for preterm infants: A double-blind randomized controlled trial. Clin Nutr. 2021 Jan;40(1):54-63. doi: 10.1016/j.clnu.2020.04.031. Epub 2020 May 6.

  PMID: 32446787 DERIVED

Study Officials

• Christph Fusch, MD, PhD, FRCPC

  McMaster Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christoph Fusch, MD, PhD, FRCPC

CONTACT

+1 905 521 2100; fusch@mcmaster.ca

Niels Rochow, MD

CONTACT

+1 905 521 2100; rochow@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Division Head

Study Record Dates

• First Submitted: May 30, 2012
• First Posted: June 1, 2012
• Study Start: August 1, 2013
• Primary Completion: June 1, 2018
• Last Updated: August 11, 2016

Record last verified: 2016-08

Locations

CA (1)