Clinical trial NCT02694510: Light Protection of TPN and Oxidative Stress in Preterm Infants
Official title: Impact of Protecting TPN Solution From Light on the Oxidant-antioxidant State of Preterm Infant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oxidative Stress in Preterm Infants
Keywords: Preterm infants
Oxidative stress
Parenteral nutrition
Lead sponsor: Mansoura University Children Hospital
Sponsor class: OTHER
First posted: 2016-02-29
Enrollment: 80
Sex: ALL
Minimum age (years): 24
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Oxidant-antioxidant state
timeFrame: 7 days
Secondary outcomes:
measure: Death and/or Bronchopulmonary dysplasia
timeFrame: 60 days
measure: Necrotizing enterocolitis as Bell's stage 2 or more
timeFrame: 60 days
measure: Sepsis
timeFrame: 60 dyas
measure: Retinopathy of prematurity pre-threshold and threshold stages
timeFrame: 60 dyas
measure: Time to full feeding
timeFrame: 30 days
measure: Duration of respiratory support
timeFrame: 60 days
measure: Neonatal cholestasis
timeFrame: 60 days
measure: Metabolic disturbance
timeFrame: 60 days
measure: Length of hospital stay
timeFrame: 60 days
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Children Hospital
state: El Dakahlya
Study officials:
References: