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Completed

NCT Number: NCT02694510

Light Protection of TPN and Oxidative Stress in Preterm Infants

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.

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Key information

Conditions

Oxidative Stress in Preterm Infants Hyperphagia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

24 hour–7 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University Children Hospital

Al Mansurah, El Dakahlya, 35111, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Preterm infant less than 32 weeks gestational age

Exclusion criteria

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

Treatment and study plan

Light-protection of TPN solutions

Other

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 outcomes

  1. Oxidant-antioxidant state

    Time frame: 7 days

    Measurement of urinary peroxides and serum GSH/GSSG ratio

Secondary outcomes

  1. Death and/or Bronchopulmonary dysplasia

    Time frame: 60 days

    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

  2. Necrotizing enterocolitis as Bell's stage 2 or more

    Time frame: 60 days

    Necrotizing enterocolitis defined by the modified by Bell's staging criteria

  3. Sepsis

    Time frame: 60 dyas

    clinical signs of sepsis confirmed by positive blood culture

  4. Retinopathy of prematurity pre-threshold and threshold stages

    Time frame: 60 dyas

    Pre-threshold and threshold stages of retinopathy of prematurity will be assessed as per our NICU routine by ophthalmology specialist.

  5. Time to full feeding

    Time frame: 30 days

    Time required to reach full enteral feeding and discontinue TPN

  6. Duration of respiratory support

    Time frame: 60 days

    Duration of mechanical ventilation, non-invasive ventilation, and oxygen therapy

  7. Neonatal cholestasis

    Time frame: 60 days

    Defined as an elevated serum conjugated bilirubin >2 mg/dL (34.2 micromoles/ l)

  8. Metabolic disturbance

    Time frame: 60 days

    Episodes of hypoglycemia less than 60 mmol/L, metabolic acidosis with pH less than 7.25 and base deficit more than 10 milliequivalent/L

  9. Length of hospital stay

    Time frame: 60 days

    Duration of admission to the neonatal care unit.

Sponsors and collaborators

Lead sponsor

Mansoura University Children Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Feb 29, 2016
Registry last updated
Jan 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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