Light Protection of TPN and Oxidative Stress in Preterm Infants
- Conditions
- Oxidative Stress in Preterm Infants
- Interventions
- Other: Light-protection of TPN solutions
- Registration Number
- NCT02694510
- Lead Sponsor
- Mansoura University Children Hospital
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- Preterm infant less than 32 weeks gestational age
- Infant with major congenital anomalies
- Infant of diabetic or hypertensive mother
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Light-protection Light-protection of TPN solutions Light-protection of TPN solutions. TPN bags and infusion sets will be protected from light by aluminum foils throughout the study period. Light-exposure Light-protection of TPN solutions TPN bags and infusion sets will be exposed to light throughout the study period.
- Primary Outcome Measures
Name Time Method Oxidant-antioxidant state 7 days Measurement of urinary peroxides and serum GSH/GSSG ratio
- Secondary Outcome Measures
Name Time Method Length of hospital stay 60 days Duration of admission to the neonatal care unit.
Metabolic disturbance 60 days Episodes of hypoglycemia less than 60 mmol/L, metabolic acidosis with pH less than 7.25 and base deficit more than 10 milliequivalent/L
Sepsis 60 dyas clinical signs of sepsis confirmed by positive blood culture
Time to full feeding 30 days Time required to reach full enteral feeding and discontinue TPN
Death and/or Bronchopulmonary dysplasia 60 days Death before hospital discharge and/or development of Bronchopulmonary dysplasia defined as oxygen requirement more than 30% fraction of inspired oxygen (FIO2) by 36 weeks corrected gestational age
Necrotizing enterocolitis as Bell's stage 2 or more 60 days Necrotizing enterocolitis defined by the modified by Bell's staging criteria
Retinopathy of prematurity pre-threshold and threshold stages 60 dyas Pre-threshold and threshold stages of retinopathy of prematurity will be assessed as per our NICU routine by ophthalmology specialist.
Duration of respiratory support 60 days Duration of mechanical ventilation, non-invasive ventilation, and oxygen therapy
Neonatal cholestasis 60 days Defined as an elevated serum conjugated bilirubin \>2 mg/dL (34.2 micromoles/ l)
Trial Locations
- Locations (1)
Mansoura University Children Hospital
🇪🇬Mansoura, El Dakahlya, Egypt