Light Protection of TPN and Oxidative Stress in Preterm Infants
Primary Purpose
Oxidative Stress in Preterm Infants
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Light-protection of TPN solutions
Sponsored by
About this trial
This is an interventional health services research trial for Oxidative Stress in Preterm Infants focused on measuring Preterm infants, Oxidative stress, Parenteral nutrition
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
Sites / Locations
- Mansoura University Children Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Light-protection
Light-exposure
Arm Description
Light-protection of TPN solutions. TPN bags and infusion sets will be protected from light by aluminum foils throughout the study period.
TPN bags and infusion sets will be exposed to light throughout the study period.
Outcomes
Primary Outcome Measures
Oxidant-antioxidant state
Measurement of urinary peroxides and serum GSH/GSSG ratio
Secondary Outcome Measures
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
Necrotizing enterocolitis as Bell's stage 2 or more
Necrotizing enterocolitis defined by the modified by Bell's staging criteria
Sepsis
clinical signs of sepsis confirmed by positive blood culture
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.
Time to full feeding
Time required to reach full enteral feeding and discontinue TPN
Duration of respiratory support
Duration of mechanical ventilation, non-invasive ventilation, and oxygen therapy
Neonatal cholestasis
Defined as an elevated serum conjugated bilirubin >2 mg/dL (34.2 micromoles/ l)
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
Length of hospital stay
Duration of admission to the neonatal care unit.
Full Information
NCT ID
NCT02694510
First Posted
February 16, 2016
Last Updated
January 24, 2018
Sponsor
Mansoura University Children Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02694510
Brief Title
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
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2014 (Actual)
Primary Completion Date
January 1, 2018 (Actual)
Study Completion Date
January 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University Children Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oxidative Stress in Preterm Infants
Keywords
Preterm infants, Oxidative stress, Parenteral nutrition
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Light-protection
Arm Type
Active Comparator
Arm Description
Light-protection of TPN solutions. TPN bags and infusion sets will be protected from light by aluminum foils throughout the study period.
Arm Title
Light-exposure
Arm Type
Active Comparator
Arm Description
TPN bags and infusion sets will be exposed to light throughout the study period.
Intervention Type
Other
Intervention Name(s)
Light-protection of TPN solutions
Intervention Description
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.
Primary Outcome Measure Information:
Title
Oxidant-antioxidant state
Description
Measurement of urinary peroxides and serum GSH/GSSG ratio
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Death and/or Bronchopulmonary dysplasia
Description
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
Time Frame
60 days
Title
Necrotizing enterocolitis as Bell's stage 2 or more
Description
Necrotizing enterocolitis defined by the modified by Bell's staging criteria
Time Frame
60 days
Title
Sepsis
Description
clinical signs of sepsis confirmed by positive blood culture
Time Frame
60 dyas
Title
Retinopathy of prematurity pre-threshold and threshold stages
Description
Pre-threshold and threshold stages of retinopathy of prematurity will be assessed as per our NICU routine by ophthalmology specialist.
Time Frame
60 dyas
Title
Time to full feeding
Description
Time required to reach full enteral feeding and discontinue TPN
Time Frame
30 days
Title
Duration of respiratory support
Description
Duration of mechanical ventilation, non-invasive ventilation, and oxygen therapy
Time Frame
60 days
Title
Neonatal cholestasis
Description
Defined as an elevated serum conjugated bilirubin >2 mg/dL (34.2 micromoles/ l)
Time Frame
60 days
Title
Metabolic disturbance
Description
Episodes of hypoglycemia less than 60 mmol/L, metabolic acidosis with pH less than 7.25 and base deficit more than 10 milliequivalent/L
Time Frame
60 days
Title
Length of hospital stay
Description
Duration of admission to the neonatal care unit.
Time Frame
60 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
24 Hours
Maximum Age & Unit of Time
7 Days
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Mansoura University Children Hospital
City
Mansoura
State/Province
El Dakahlya
ZIP/Postal Code
35111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Light Protection of TPN and Oxidative Stress in Preterm Infants
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