Light Protection of TPN and Oxidative Stress in Preterm Infants

Oxidative Stress in Preterm Infants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02694510
• Other study ID #: MS/299
• Status: Completed
• Phase: N/A
• First received: February 16, 2016
• Last updated: January 24, 2018
• Start date: January 1, 2014
• Est. completion date: January 1, 2018

Study information

• Verified date: January 2018
• Source: Mansoura University Children Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 1, 2018
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 7 Days

Eligibility

Inclusion Criteria:

• Preterm infant less than 32 weeks gestational age

Exclusion Criteria:

• Infant with major congenital anomalies

• Infant of diabetic or hypertensive mother

Related Conditions & MeSH terms

• Oxidative Stress in Preterm Infants
• Premature Birth

Intervention

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.

Locations

Country	Name	City	State
Egypt	Mansoura University Children Hospital	Mansoura	El Dakahlya

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University Children Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxidant-antioxidant state	Measurement of urinary peroxides and serum GSH/GSSG ratio	7 days
Secondary	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
Secondary	Necrotizing enterocolitis as Bell's stage 2 or more	Necrotizing enterocolitis defined by the modified by Bell's staging criteria	60 days
Secondary	Sepsis	clinical signs of sepsis confirmed by positive blood culture	60 dyas
Secondary	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
Secondary	Time to full feeding	Time required to reach full enteral feeding and discontinue TPN	30 days
Secondary	Duration of respiratory support	Duration of mechanical ventilation, non-invasive ventilation, and oxygen therapy	60 days
Secondary	Neonatal cholestasis	Defined as an elevated serum conjugated bilirubin >2 mg/dL (34.2 micromoles/ l)	60 days
Secondary	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
Secondary	Length of hospital stay	Duration of admission to the neonatal care unit.	60 days