Light Protection of TPN and Oxidative Stress in Preterm Infants

M

Mansoura University Children Hospital

Status

Completed

Conditions

Oxidative Stress in Preterm Infants

Treatments

Other: Light-protection of TPN solutions

Study type

Interventional

Funder types

Other

Identifiers

NCT02694510
MS/299

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 patients

Sex

All

Ages

24 hours to 7 days old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Preterm infant less than 32 weeks gestational age

Exclusion criteria

  • Infant with major congenital anomalies
  • Infant of diabetic or hypertensive mother

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

80 participants in 2 patient groups

Light-protection
Active Comparator group
Description:
Light-protection of TPN solutions. TPN bags and infusion sets will be protected from light by aluminum foils throughout the study period.
Treatment:
Other: Light-protection of TPN solutions
Light-exposure
Active Comparator group
Description:
TPN bags and infusion sets will be exposed to light throughout the study period.
Treatment:
Other: Light-protection of TPN solutions

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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