Individualized Fortification of Breast Milk for Preterm Infants - A Pilot Study
Not Applicable
Completed
- Conditions
- Postnatal Growth Disorder
- Registration Number
- NCT01305642
- Lead Sponsor
- McMaster Children's Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 13
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method growth from inclusion at postmentrual age <32 weeks until 36 weeks weight gain will be accessed three times per week
- Secondary Outcome Measures
Name Time Method enteral energy intake from inclusion at postmentrual age <32 weeks until 36 weeks caloric intake by enteral feeding will be assesed daily
growth, tolerance, morbidity from inclusion at postmentrual age <32 weeks until 36 weeks gains in length and head circumference will be assessed weekly, tolerance and morbidity throughout study
Trial Locations
- Locations (1)
McMaster Children's Hospital
🇨🇦Hamilton, Ontario, Canada
McMaster Children's Hospital🇨🇦Hamilton, Ontario, Canada