Light Protection of TPN and Oxidative Stress in Preterm Infants

Study Overview
=================
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.

Official Title
-----------------
Impact of Protecting TPN Solution From Light on the Oxidant-antioxidant State of Preterm Infant

Conditions
-----------------
Oxidative Stress in Preterm Infants

Intervention / Treatment
-----------------
* Other: Light-protection of TPN solutions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preterm infant less than 32 weeks gestational age Exclusion Criteria: Infant with major congenital anomalies Infant of diabetic or hypertensive mother

Ages Eligible for Study
-----------------
Minimum Age: 24 Hours
Maximum Age: 7 Days

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Light-protection<br>Light-protection of TPN solutions. TPN bags and infusion sets will be protected from light by aluminum foils throughout the study period. | Other: Light-protection of TPN solutions<br>* 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.<br>|
| Active Comparator: Light-exposure<br>TPN bags and infusion sets will be exposed to light throughout the study period. | Other: Light-protection of TPN solutions<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxidant-antioxidant state | Measurement of urinary peroxides and serum GSH/GSSG ratio | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death and/or Bronchopulmonary dysplasia | 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 | 60 days | 
| Necrotizing enterocolitis as Bell's stage 2 or more | Necrotizing enterocolitis defined by the modified by Bell's staging criteria | 60 days | 
| Sepsis | clinical signs of sepsis confirmed by positive blood culture | 60 dyas | 
| Retinopathy of prematurity pre-threshold and threshold stages | Pre-threshold and threshold stages of retinopathy of prematurity will be assessed as per our NICU routine by ophthalmology specialist. | 60 dyas | 
| Time to full feeding | Time required to reach full enteral feeding and discontinue TPN | 30 days | 
| Duration of respiratory support | Duration of mechanical ventilation, non-invasive ventilation, and oxygen therapy | 60 days | 
| Neonatal cholestasis | Defined as an elevated serum conjugated bilirubin >2 mg/dL (34.2 micromoles/ l) | 60 days | 
| Metabolic disturbance | Episodes of hypoglycemia less than 60 mmol/L, metabolic acidosis with pH less than 7.25 and base deficit more than 10 milliequivalent/L | 60 days | 
| Length of hospital stay | Duration of admission to the neonatal care unit. | 60 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Preterm infants, Oxidative stress, Parenteral nutrition