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OpenTrials
Completed

NCT Number: NCT01860573

Neurodevelopmental and Growth Outcomes of Early, Aggressive Protein Intake in Very Low Birthweight Infants

The purpose of this study is to determine whether providing increased protein to premature infants in the first week of life allows for better growth during the hospital stay and improved developmental outcomes by age 2.

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Key information

Conditions

Prematurity Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 18 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Women & Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • birth weight 400 to 1250 grams
  • 24 0/7 to 30 6/7 weeks gestational age

Exclusion criteria

  • chromosomal, structural, metabolic, endocrine, or renal abnormalities that could affect growth
  • infants >18 hours of age
  • infants in extremis who are unlikely to survive past 72 hours

Treatment and study plan

Amino Acids

Drug

Other names: Premasol

Primary outcomes

  1. Number of Participants With Weight<10th Percentile for Age

    Time frame: 36 weeks post-conceptual age

  2. Number of Participants With Length <10th Percentile for Age

    Time frame: 36 weeks post-conceptual age

  3. Number of Participants With Head Circumference <10th Percentile for Age

    Time frame: 36 weeks post-conceptual age

  4. Cognitive Development Score

    Time frame: 18-22 months corrected gestational age

    Reported as units on a scale with mean of 100 and a Standard Deviation of 15, and range from 40-160. Higher values indicate a better outcome.

Secondary outcomes

  1. Serum Bicarbonate

    Time frame: Day of life 1, 2, 3, 5 and 7

  2. Serum Creatinine

    Time frame: Day of life 1, 2, 3, 5 and 7

  3. Serum Blood Urea Nitrogen

    Time frame: Day of life 1, 2, 3, 5 and 7

Sponsors and collaborators

Lead sponsor

Women and Infants Hospital of Rhode Island

Other

Registry information

Important dates

Study start
2008
Primary completion
2013
Study completion
2016
First posted
May 22, 2013
Registry last updated
Apr 10, 2017

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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