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

McMaster Children's Hospital1 site in 1 country13 target enrollmentFebruary 2011

ConditionsPostnatal Growth Disorder

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Postnatal Growth Disorder
Sponsor: McMaster Children's Hospital
Enrollment: 13
Locations: 1
Primary Endpoint: growth
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2011

End Date

December 2011

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

McMaster Children's Hospital

Responsible Party

Principal Investigator

Christoph Fusch

Professor and Division Head

McMaster Children's Hospital

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
•Necrotizing enterocolitis
•Hepatic dysfunction

Outcomes

Primary Outcomes

growth

Time Frame: from inclusion at postmentrual age <32 weeks until 36 weeks

weight gain will be accessed three times per week

Secondary Outcomes

enteral energy intake(from inclusion at postmentrual age <32 weeks until 36 weeks)
growth, tolerance, morbidity(from inclusion at postmentrual age <32 weeks until 36 weeks)