Oxidative Stress in Preterm Infants Clinical Trial
Official title:
Impact of Protecting TPN Solution From Light on the Oxidant-antioxidant State of Preterm Infant
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.
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.
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