Recruiting

Individualized Fortification

Sponsor:

McMaster Children's Hospital

Code:

NCT01609894

Conditions

Postnatal Growth Disorder

Neurodevelopment

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Individualized fortification of breast milk

Routine fortification of breast milk

Study Details

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 ID

NCT01609894

Start date

Aug, 2013

Status verified date

Aug, 2016

Primary completion date

Jun, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

112 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: 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.

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.

Routine fortification of breast milk

Infants will be fed routine fortified breast milk.

Primary outcome measure

  • growth during first three weeks of intervention [ Time Frame: first three weeks during intervention before 36 weeks of gestation ]

Central Contacts and Locations

Central contacts

Christoph Fusch, MD, PhD, FRCPC

+1 905 521 2100fusch@mcmaster.ca

Locations

Faculty of Health Science, McMaster Children's Hospital

Recruiting

Hamilton, Ontario, Canada, L8S 4K1

Contacts

Christoph Fusch, MD, PhD, FRCPC

+1 905 521 2100fusch@mcmaster.ca

Principal Investigator:

Christoph Fusch, MD, PhD, FRCPC

More Information

Sponsor

McMaster Children's Hospital

Last update posted

Aug 11, 2016

Last verified

Aug, 2016

Keywords

  • Postnatal development
  • Breast milk fortification
  • Composition of breast milk

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McMaster Children's Hospital on 2016-08-11.