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

McMaster Children's Hospital

Status: Completed

Conditions: Postnatal Growth Disorder

Treatments: Dietary Supplement: Individualized fortification of breast milk

Study type: Interventional

Funder types: Other

Identifiers

NCT01305642

201101IFOPILOT

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: Under 32 weeks old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

Individualized fortification of breast milk

Experimental group

Treatment:

Dietary Supplement: Individualized fortification of breast milk