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Completed

NCT Number: NCT01305642

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

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.

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Key information

Conditions

Postnatal Growth Disorder

Age range

Up to 32 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McMaster Children's Hospital

Hamilton, Ontario, L8N3Z5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Individualized fortification of breast milk

Dietary Supplement

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 outcomes

  1. growth

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

    weight gain will be accessed three times per week

Secondary outcomes

  1. enteral energy intake

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

    caloric intake by enteral feeding will be assesed daily

  2. growth, tolerance, morbidity

    Time frame: 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

Sponsors and collaborators

Lead sponsor

McMaster Children's Hospital

Other

Registry information

Acronym: IFO Pilot

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Mar 1, 2011
Registry last updated
Aug 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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