Light Protection of TPN and Oxidative Stress in Preterm Infants
Condition: Oxidative Stress in Preterm Infants
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      Urinary peroxides and plasma glutathione/glutathione disulfide (GSH/GSSG) ratio will be
      measured in preterm infants less than 32 weeks gestation before and 7 days after receiving
      either Light-protected (Group 1) or Light-exposed (Group 2) Total Parenteral Nutrition (TPN)
      solutions.
    

Detailed description: 
      This study will be a prospective single blinded randomized control trial.

      Inborn preterm infant less than 32 wks gestational age, receiving TPN in neonatal intensive
      care unit (NICU) of Mansoura University Children's Hospital as a part of their care will be
      included.

      Preterm infant will be randomly divided into 2group:- Group 1 includes preterm infant who
      will receive their TPN through bags and tubing system that are protected from light by
      aluminum foil.

      Group 2 includes preterm infant who will receive their TPN through bags and tubing system
      that are exposed to light.

      Randomization will be done using random table technique with opaque sealed envelopes
      containing the serial number and the group to which the subject will be enrolled.

      These envelopes will be kept in the unit ready for use at any time; each one has a number
      which is the serial number of the baby and group of TPN to which the baby will be enrolled.

      The urine sample will be sent to the laboratory with this serial number with no information
      about the group of study to which this sample follows for peroxide level as well as blood
      sample for GSH\GSSG.

      Two blood samples and two urine samples will be collected. The first one will be at 0 hour
      before starting TPN regimen as a base line and the second will be at 7 days of starting TPN
      regimen. Blood sample will be at least 1cc of blood for GSH/GSSG assay. Urine collection bag
      will be placed on the infant to obtain minimum of 1cc of urine for urinary peroxide level
      assay.

      Other secondary outcomes will be assessed with duration of NICU admission including death and
      /or bronchopulmonary dysplasia in preterm infant at time of hospital discharge, necrotizing
      enterocolitis (NEC), sepsis with positive blood cultures, length of hospital stay,
      retinopathy of prematurity (ROP), time to full enteral feeding, duration of respiratory
      support, liver function, cholestasis defined as an elevated serum conjugated bilirubin >2
      mg/dL, and metabolic response.
    

Intervention name(s): Light-protection of TPN solutions
Intervention type(s): Other
Intervention description(s): TPN bags and infusion sets in the Light-protected group will be covered by aluminum foils to protect the inside TPN solution from exposure to ambient or photo-therapy lights in the NICU. Protection will be made throughout the study period until the infant reaches full feeding and TPN is discontinued.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Preterm infants; Oxidative stress; Parenteral nutrition