Primary Objective: Assess whether parental rating of problems on the Attention and Social Withdrawal indices of the Child Behavior Checklist at 4 years of age for children of mothers who received prenatal phosphatidylcholine supplementation are lower, compared to children whose mothers received placebo.
II - Research Studies that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied.
Colorado Research Center
Denver Health Medical Center
Department Specific Free Standing Clinic
University of Colorado Hospital
Camille Hoffman, MD, MSc
Protocol Number: 16-1510
More information available at ClinicalTrials.gov: NCT03028857
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