Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01305642
Acronym
IFO Pilot
Enrollment
13
Registered
2011-03-01
Start date
2011-02-28
Completion date
2011-12-31
Last updated
2016-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postnatal Growth Disorder

Keywords

Postnatal development, Breast milk fortification, Composition of breast milk

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.

Interventions

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.

Sponsors

McMaster Children's Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 32 Weeks
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
growthfrom inclusion at postmentrual age <32 weeks until 36 weeksweight gain will be accessed three times per week

Secondary

MeasureTime frameDescription
enteral energy intakefrom inclusion at postmentrual age <32 weeks until 36 weekscaloric intake by enteral feeding will be assesed daily
growth, tolerance, morbidityfrom inclusion at postmentrual age <32 weeks until 36 weeksgains in length and head circumference will be assessed weekly, tolerance and morbidity throughout study

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026