A Phase 2b, Multicenter, Randomized, Open-label, Controlled, 3-Arm Study to Evaluate the Clinical Efficacy and Safety of SHP607 in Preventing Chronic Lung Disease Through 12 Months Corrected Age Compared to Standard Neonatal Care in Extremely Premature Infants Save

Date Added
December 10th, 2019
PRO Number
Pro00091762
Researcher
Carol Wagner

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Keywords
Children's Health, Infant, Pediatrics
Summary

Babies that are born extremely prematurely are at higher risk of developing chronic (long term) lung disease (CLD) and other complications (problems). The purpose of this study is to test the safety and effectiveness of an investigational drug called mecasermin rinfabate (rhIGF-1/rhIGTBP-3) or SHP607. The researchers want to find out if SHP607 can help reduce the risk of chronic lung disease in babies born prematurely and if it can help reduce the risk of other complications.

Institution
MUSC
Recruitment Contact
Della MacNicholas
843-792-8385
macnichd@musc.edu

Maternal vs. Direct Infant Vitamin D Supplementation during Lactation RCT: Priming the Infant Immune System: Pilot Study Save

Date Added
January 5th, 2016
PRO Number
Pro00050609
Researcher
Carol Wagner

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Keywords
Lactation, Vitamin D
Summary

Breastfeeding is important for the development of the immune system of the infant. Emerging data suggest that vitamin D plays an important role in immunity as well. Exclusively breastfeeding mothers and their infants will be studied in a 3-month (4-study visit) pilot study of vitamin D supplementation versus placebo. Longitudinal effects of vitamin D status on breast milk composition and on the infant's immune system will be examined.
Additionally, exclusively breastfeeding mothers who are currently on vitamin D supplementation will be studied at a single visit, at which mothers will provide a single breastmilk sample and have a single blood sample obtained. These samples will be used to examine effects of vitamin D supplementation on breast milk composition.

Institution
MUSC
Recruitment Contact
Renee Washington
843-792-5884
washinro@musc.edu

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