Individualized Fortification of Breast Milk

NCT ID: NCT01609894

Last Updated: 2016-08-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Individualized fortification of breast milk

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.

Group Type: EXPERIMENTAL

Individualized fortification of breast milk

Intervention Type: 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.

Routine fortification of breast milk

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.

Group Type: ACTIVE_COMPARATOR

Routine fortification of breast milk

Intervention Type: DIETARY_SUPPLEMENT

Infants will be fed routine fortified breast milk.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Routine fortification of breast milk

Infants will be fed routine fortified breast milk.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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.

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.

• Maximum Eligible Age: 32 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McMaster Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Christoph Fusch

Professor and Division Head

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christph Fusch, MD, PhD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

McMaster Children's Hospital

Locations

Faculty of Health Science, McMaster Children's Hospital

Hamilton, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Christoph Fusch, MD, PhD, FRCPC

Role: CONTACT

fusch@mcmaster.ca

+1 905 521 2100 ext. 75721

Niels Rochow, MD

Role: CONTACT

rochow@mcmaster.ca

+1 905 521 2100 ext. 23106

Facility Contacts

Christoph Fusch, MD, PhD, FRCPC

Role: primary

fusch@mcmaster.ca

+1 905 521 2100 ext. 75721

References

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.

Reference Type: DERIVED

PMID: 33226632 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32446787 (View on PubMed)

Other Identifiers

201205IFO

Identifier Type: -

Identifier Source: org_study_id