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Completed

NCT Number: NCT01988792

Human Milk Fortification in Very Low Birth Neonates

The purpose of this study to find out how safely we can add extra nutrients to human milk at different feeding volume.

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Key information

Conditions

Premature; Infant Enteral Nutrition Female Urogenital Diseases and Pregnancy Complications Fortification Human Milk Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

2 day–7 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Tennessee, Health Science Center, The Regional Medical Center

Memphis, Tennessee, 38163, United States

About this study

Very low birth weight babies (weight less than three pounds and three ounces) are extremely fragile and lacking important nutrition due to premature birth. They need enough calories for catch-up growth. Giving adequate nutrition is very important for their growth and development. Human milk is the best food, however it is not enough to provide all the required calories and nutrients for catch up growth and maintain adequate strength of the bones (bone mineralization). For premature babies, extra nutrients (human milk fortifier) are usually added to the human milk to provide adequate nutrition. These extra nutrients will be derived from cow's milk. Currently, a practice of fortifying human milk varies. There is no clear information when to start adding extra nutrients to human milk.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Very low birth weight infants who receive human milk (mother's milk or banked donor human milk).

Exclusion criteria

  • Major congenital anomalies such as cardiac defect, neural tube defect, chromosomal abnormality and gastrointestinal defect.
  • Died or extended to die within 48 hours of life

Treatment and study plan

Human milk fortifiers

Dietary Supplement

Primary outcomes

  1. The days to reach full enteral feeding volume (140 ml/kg/day).

    Time frame: 4 - 6 weeks

Secondary outcomes

  1. Neonatal Outcomes

    Time frame: until 36 weeks PMA

    Necrotizing Enterocolitis

  2. Neonatal Outcomes

    Time frame: until 36 weeks PMA

    Chronic Lung Disease

  3. Neonatal Outcomes

    Time frame: Until full feeding volume

    Feeding intolerance

  4. Neonatal Outcomes

    Time frame: Until full feeding volume

    Parental nutrition days

  5. Neonatal Outcomes

    Time frame: until 36 weeks PMA

    Ventilator days

  6. Neonatal Outcomes

    Time frame: until 4 weeks of life

    Protein and caloric intake

  7. Neonatal Outcomes

    Time frame: until 4 weeks of life

    Growth anthropometry

Sponsors and collaborators

Lead sponsor

University of Tennessee

Other

Registry information

Official study title

Human Milk Fortification and Feeding Intolerance in Very Low Birth Weight Neonates

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 20, 2013
Registry last updated
Jul 29, 2015

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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