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Individualized Fortification of Breast Milk for Preterm Infants - A Pilot Study (IFO Pilot)

Primary Purpose

Postnatal Growth Disorder

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Individualized fortification of breast milk
Sponsored by
McMaster Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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:

  • Birth weight ≤ 1500g and gestational age < 32weeks
  • Tolerating an enteral intake of ≥ 100 ml/kg/d for ≥ 24h

Exclusion Criteria:

  • Infants fed more than 25% of mean caloric intake for a consecutive week with formula milk
  • gastrointestinal malformation, major congenital anomalies and chromosomal abnormalities
  • Babies with enterostoma or short gut syndrome
  • Fluid restriction below
  • Renal disease
  • Sepsis
  • Necrotizing enterocolitis
  • Hepatic dysfunction

Sites / Locations

  • McMaster Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Individualized fortification of breast milk

Arm Description

Outcomes

Primary Outcome Measures

growth
weight gain will be accessed three times per week

Secondary Outcome Measures

enteral energy intake
caloric intake by enteral feeding will be assesed daily
growth, tolerance, morbidity
gains in length and head circumference will be assessed weekly, tolerance and morbidity throughout study

Full Information

First Posted
February 28, 2011
Last Updated
August 8, 2016
Sponsor
McMaster Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01305642
Brief Title
Individualized Fortification of Breast Milk for Preterm Infants - A Pilot Study
Acronym
IFO Pilot
Official Title
Individualized Fortification of Breast Milk for Preterm Infants - A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster Children's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To analyze the weight gain of very low birth weight infants during a minimum period of three weeks before 36 weeks postmenstrual age when infants are fed with breast milk that has been individually fortified.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postnatal Growth Disorder
Keywords
Postnatal development, Breast milk fortification, Composition of breast milk

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Individualized fortification of breast milk
Arm Type
Experimental
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.
Primary Outcome Measure Information:
Title
growth
Description
weight gain will be accessed three times per week
Time Frame
from inclusion at postmentrual age <32 weeks until 36 weeks
Secondary Outcome Measure Information:
Title
enteral energy intake
Description
caloric intake by enteral feeding will be assesed daily
Time Frame
from inclusion at postmentrual age <32 weeks until 36 weeks
Title
growth, tolerance, morbidity
Description
gains in length and head circumference will be assessed weekly, tolerance and morbidity throughout study
Time Frame
from inclusion at postmentrual age <32 weeks until 36 weeks

10. Eligibility

Sex
All
Maximum Age & Unit of Time
32 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Birth weight ≤ 1500g and gestational age < 32weeks Tolerating an enteral intake of ≥ 100 ml/kg/d for ≥ 24h Exclusion Criteria: Infants fed more than 25% of mean caloric intake for a consecutive week with formula milk gastrointestinal malformation, major congenital anomalies and chromosomal abnormalities Babies with enterostoma or short gut syndrome Fluid restriction below Renal disease Sepsis Necrotizing enterocolitis Hepatic dysfunction
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christoph Fusch, MD,PhD,FRCPC
Organizational Affiliation
McMaster Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster Children's Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N3Z5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
22041090
Citation
Fusch G, Choi A, Rochow N, Fusch C. Quantification of lactose content in human and cow's milk using UPLC-tandem mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci. 2011 Dec 1;879(31):3759-62. doi: 10.1016/j.jchromb.2011.09.053. Epub 2011 Oct 6.
Results Reference
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PubMed Identifier
24912866
Citation
Fusch G, Rochow N, Choi A, Fusch S, Poeschl S, Ubah AO, Lee SY, Raja P, Fusch C. Rapid measurement of macronutrients in breast milk: How reliable are infrared milk analyzers? Clin Nutr. 2015 Jun;34(3):465-76. doi: 10.1016/j.clnu.2014.05.005. Epub 2014 May 17.
Results Reference
background
PubMed Identifier
25213193
Citation
Fusch G, Mitra S, Rochow N, Fusch C. Target fortification of breast milk: levels of fat, protein or lactose are not related. Acta Paediatr. 2015 Jan;104(1):38-42. doi: 10.1111/apa.12804. Epub 2014 Oct 2.
Results Reference
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PubMed Identifier
25807355
Citation
Rochow N, Landau-Crangle E, Fusch C. Challenges in breast milk fortification for preterm infants. Curr Opin Clin Nutr Metab Care. 2015 May;18(3):276-84. doi: 10.1097/MCO.0000000000000167.
Results Reference
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PubMed Identifier
25835073
Citation
Rochow N, Fusch G, Zapanta B, Ali A, Barui S, Fusch C. Target fortification of breast milk: how often should milk analysis be done? Nutrients. 2015 Apr 1;7(4):2297-310. doi: 10.3390/nu7042297.
Results Reference
background
PubMed Identifier
26663457
Citation
Fusch G, Kwan C, Huang RC, Rochow N, Fusch C. Need of quality control programme when using near-infrared human milk analyzers. Acta Paediatr. 2016 Mar;105(3):324-5. doi: 10.1111/apa.13305. Epub 2016 Jan 19. No abstract available.
Results Reference
background
PubMed Identifier
26863130
Citation
Choi A, Fusch G, Rochow N, Fusch C. Target Fortification of Breast Milk: Predicting the Final Osmolality of the Feeds. PLoS One. 2016 Feb 10;11(2):e0148941. doi: 10.1371/journal.pone.0148941. eCollection 2016.
Results Reference
background
PubMed Identifier
26927169
Citation
Kotrri G, Fusch G, Kwan C, Choi D, Choi A, Al Kafi N, Rochow N, Fusch C. Validation of Correction Algorithms for Near-IR Analysis of Human Milk in an Independent Sample Set-Effect of Pasteurization. Nutrients. 2016 Feb 26;8(3):119. doi: 10.3390/nu8030119.
Results Reference
background
PubMed Identifier
23769498
Citation
Rochow N, Fusch G, Choi A, Chessell L, Elliott L, McDonald K, Kuiper E, Purcha M, Turner S, Chan E, Xia MY, Fusch C. Target fortification of breast milk with fat, protein, and carbohydrates for preterm infants. J Pediatr. 2013 Oct;163(4):1001-7. doi: 10.1016/j.jpeds.2013.04.052. Epub 2013 Jun 12.
Results Reference
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Individualized Fortification of Breast Milk for Preterm Infants - A Pilot Study

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