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Completed

NCT Number: NCT01936246

Protein Supplementation in Infants With Brain Injury

To date, few studies have been done regarding nutrition supplementation in infants with brain injury. Therefore, the investigators are proposing to study the effects of protein supplementation in this group of babies. The investigators will recruit 24 infants with brain injury (evidence of hemorrhage, white matter injury, or gray matter injury) admitted to the Cincinnati Children's Hospital Neonatal Intensive Care Unit (NICU) into the study. Upon diagnosis, the investigators will obtain consent from the parents for participation in the study, then randomly assign the baby to one of two groups - an increased protein group and a control group. Both groups of infants will be monitored to ensure no adverse effects occur due to the supplementation.

Protein supplementation will continue for the first 12 months of age. Growth parameters, such as weight, length, and head circumference, will be measured while the infant is the NICU. Head circumference will be measured in the investigators outpatient clinic at three, six, and 12 months of age. At 18-22 months, the infants will be tested for neurodevelopmental outcomes using the Bayley Scales of Infant Development. The investigators hypothesize that infants who receive the additional protein will demonstrate increased head growth and improved neurodevelopmental outcomes.

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Key information

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Infants admitted to the NICU at CCHMC
  • Known or suspected brain injury
  • Parental consent obtained
  • At least 48 hours of age at the time of randomization

Exclusion criteria

  • Congenital or posthemorrhagic hydrocephalus
  • Major congenital brain malformations
  • Congenital gastrointestinal malformations or Bell Stage III NEC
  • Inborn errors of metabolism
  • Chromosomal abnormalities
  • Significant cardiac disease

Treatment and study plan

Increased protein

Dietary Supplement

Other names: Beneprotein or Complete Amino Acids

Primary outcomes

  1. Head circumference

    Time frame: 12 months of age +/- 4 weeks

Secondary outcomes

  1. Neurodevelopmental outcome on Bayley Scales of Infant Development

    Time frame: 18-22 months

  2. Weight and length

    Time frame: 3, 6, 12 months of age

Other outcomes

  1. Blood urea nitrogen

    Time frame: 10 and 30 days post study initiation

  2. CO2 from renal panel

    Time frame: 10 and 30 days post study initiation

    To assess for metabolic acidosis

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

  • The Gerber Foundation

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2016
First posted
Sep 6, 2013
Registry last updated
Jul 6, 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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