Light Protection of TPN and Oxidative Stress in Preterm Infants

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.

Study Overview

• Status: Completed
• Conditions: Oxidative Stress in Preterm Infants
• Intervention / Treatment: Other: Light-protection of 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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El Dakahlya
    • Mansoura, El Dakahlya, Egypt, 35111
      • Mansoura University Children Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 1 week (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Preterm infant less than 32 weeks gestational age

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Light-protection; 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; 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.
Active Comparator: Light-exposure; TPN bags and infusion sets will be exposed to light throughout the study period.	Other: Light-protection of TPN solutions; 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.

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

Collaborators and Investigators

• Sponsor: Mansoura University Children Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: February 16, 2016
• First Submitted That Met QC Criteria: February 23, 2016
• First Posted (Estimate): February 29, 2016

Study Record Updates

• Last Update Posted (Actual): January 26, 2018
• Last Update Submitted That Met QC Criteria: January 24, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Oxidative stress; Preterm infants; Parenteral nutrition
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: MS/299

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided