Back to results

Individualized Fortification of Breast Milk (IFO)

Primary Purpose

Postnatal Growth Disorder, Neurodevelopment

Status

Unknown status

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Individualized fortification of breast milk

Routine fortification of breast milk

About this trial

This is an interventional treatment trial for Postnatal Growth Disorder focused on measuring Postnatal development, Breast milk fortification, Composition of breast milk

Eligibility Criteria

undefined - 32 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion criteria:

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.

Exclusion criteria:

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.

Post-randomisation exclusion criteria:

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.

Sites / Locations

Faculty of Health Science, McMaster Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Individualized fortification of breast milk

Routine fortification of breast milk

Arm Description

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

Outcomes

Primary Outcome Measures

growth during first three weeks of intervention

change in body weight gain will be accessed daily.

Secondary Outcome Measures

enteral energy intake

fat, carbohydrate, protein, and caloric intake by enteral feeding will be assesed daily

neurodevelopment

Bayley Scales of Infant Development III

weight gain

change in body weight [g]

body length

change in body length [cm]

head circumference

change in head circumference [cm]

body composition

change in body composition measured with air displacement plethysmography (body weight, body volume, calculated fat and lean mass)

body composition (bio-electrical impedance analysis)

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

change in skin fold thickness [cm]

feeding intolerance

occurence of feeding intolerance defined by vomitting, bloody gastric residuals, or abnormal abdomen (tender, discolored, absent bowel sounds)

morbidity

nutrient's blood parameter

triglycerides, glucose, blood urea nitrogen, blood gases, electrolytes, pH

breast milk analysis

using near-infrared analysis breast milk's macronutrients (fat, lactose and protein) will be measured daily

Full Information

NCT ID

NCT01609894

First Posted

May 30, 2012

Last Updated

August 10, 2016

Sponsor

McMaster Children's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01609894

Brief Title

Individualized Fortification of Breast Milk

Acronym

IFO

Official Title

Individualized Fortification of Breast Milk With Fat, Carbohydrate and Protein for Preterm Infants

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Unknown status

Study Start Date

August 2013 (undefined)

Primary Completion Date

June 2018 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

McMaster Children's Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postnatal Growth Disorder, Neurodevelopment

Keywords

Postnatal development, Breast milk fortification, Composition of breast milk

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

112 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Individualized fortification of breast milk

Arm Type

Experimental

Arm Description

Arm Title

Routine fortification of breast milk

Arm Type

Active Comparator

Arm Description

Intervention Type

Dietary Supplement

Intervention Name(s)

Individualized fortification of breast milk

Intervention Description

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

Intervention Name(s)

Routine fortification of breast milk

Intervention Description

Infants will be fed routine fortified breast milk.

Primary Outcome Measure Information:

Title

growth during first three weeks of intervention

Description

change in body weight gain will be accessed daily.

Time Frame

first three weeks during intervention before 36 weeks of gestation

Secondary Outcome Measure Information:

Title

enteral energy intake

Description

fat, carbohydrate, protein, and caloric intake by enteral feeding will be assesed daily

Time Frame

from inclusion at postmentrual age <32 weeks until 36 weeks

Title

neurodevelopment

Description

Bayley Scales of Infant Development III

Time Frame

at 18 month corrected age

Title

weight gain

Description

change in body weight [g]

Time Frame

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

Title

body length

Description

change in body length [cm]

Time Frame

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

Title

head circumference

Description

change in head circumference [cm]

Time Frame

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

Title

body composition

Description

change in body composition measured with air displacement plethysmography (body weight, body volume, calculated fat and lean mass)

Time Frame

from inclusion at postmentrual age <32 weeks until 3 month corrected age

Title

body composition (bio-electrical impedance analysis)

Description

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)

Time Frame

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

Title

skin fold thickness

Description

change in skin fold thickness [cm]

Time Frame

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

Title

feeding intolerance

Description

occurence of feeding intolerance defined by vomitting, bloody gastric residuals, or abnormal abdomen (tender, discolored, absent bowel sounds)

Time Frame

during intervention (postmentrual age <32 weeks until 36 weeks)

Title

morbidity

Time Frame

during intervention (postmentrual age <32 weeks until 36 weeks)

Title

nutrient's blood parameter

Description

triglycerides, glucose, blood urea nitrogen, blood gases, electrolytes, pH

Time Frame

during intervention (postmentrual age <32 weeks until 36 weeks)

Title

breast milk analysis

Description

using near-infrared analysis breast milk's macronutrients (fat, lactose and protein) will be measured daily

Time Frame

during intervention (postmentrual age <32 weeks until 36 weeks)

10. Eligibility

Sex

All

Maximum Age & Unit of Time

32 Weeks

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: 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. Exclusion criteria: 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. Post-randomisation exclusion criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Christoph Fusch, MD, PhD, FRCPC

Phone

+1 905 521 2100

Ext

75721

fusch@mcmaster.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Niels Rochow, MD

Phone

+1 905 521 2100

Ext

23106

rochow@mcmaster.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christph Fusch, MD, PhD, FRCPC

Organizational Affiliation

McMaster Children's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Faculty of Health Science, McMaster Children's Hospital

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8S 4K1

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christoph Fusch, MD, PhD, FRCPC

Phone

+1 905 521 2100

Ext

75721

fusch@mcmaster.ca

First Name & Middle Initial & Last Name & Degree

Christoph Fusch, MD, PhD, FRCPC

First Name & Middle Initial & Last Name & Degree

Niels Rochow, MD

First Name & Middle Initial & Last Name & Degree

Gerhard Fusch, PhD

First Name & Middle Initial & Last Name & Degree

Salhab el Helou, MD, FRCPC

First Name & Middle Initial & Last Name & Degree

Sabiha Ahmad

First Name & Middle Initial & Last Name & Degree

Akshdeep Singh Bhatia

First Name & Middle Initial & Last Name & Degree

Klaus Wutzke, PhD

12. IPD Sharing Statement

Citations:

PubMed Identifier

33226632

Citation

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.

Results Reference

derived

PubMed Identifier

32446787

Citation

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.

Results Reference

derived

Learn more about this trial

Individualized Fortification of Breast Milk

We'll reach out to this number within 24 hrs