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OpenTrials
Completed

NCT Number: NCT01991613

Early Protein Supplementation of Human Milk in Extremely Low Birth Weight Infants

We hypothesize that premature infants who receive their mothers' expressed breast milk supplemented with liquid protein early in their hospitalization will have a growth velocity in the first 28 days of life that is 20% greater than the growth velocity of premature infants that do not receive protein fortification.

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Key information

Conditions

Growth in Premature Infants

Age range

26 week–33 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • inborn at Mount Sinai Medical Center
  • gestational age between 26 0/7 weeks and 32 6/7 weeks gestation
  • plan by family for their infant to receive human milk feeds

Exclusion criteria

  • outborn infants
  • gestational age < 26 0/7 weeks or > 33 0/7 weeks
  • major congenital anomalies including cardiac disease, inborn errors of metabolism etc.
  • sepsis and/or other serious clinical complication precluding initiation of enteral feeds
  • plan by family for their infant to receive primarily preterm infant formula.

Treatment and study plan

liquid protein supplement

Dietary Supplement

The liquid protein supplement is already in use. The purpose of this study is to determine whether using the supplement earlier will lead to improved growth.

Other names: Abbott liquid protein supplement

Primary outcomes

  1. Growth velocity

    Time frame: up to 28 days

    Growth velocity over the first 28 days of life - Daily weight measurements for the first 28 days of life

Secondary outcomes

  1. weight

    Time frame: average 11 weeks

    Extrauterine growth from birth until discharge from the NICU - Weekly weight measurements until discharge from the NICU

  2. Length

    Time frame: average 11 weeks

    Extrauterine growth from birth until discharge from the NICU - Weekly length measurements until discharge from the NICU

  3. head circumference

    Time frame: average 11 weeks

    Extrauterine growth from birth until discharge from the NICU - Weekly head circumference measurements until discharge from the NICU

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

Early Liquid Protein Supplementation of Human Milk in Extremely Low Birth Weight Infants

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 25, 2013
Registry last updated
Sep 23, 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.