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Trial record 2 of 68 for:    tpn

Light Protection of TPN and Oxidative Stress in Preterm Infants

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ClinicalTrials.gov Identifier: NCT02694510
Recruitment Status : Completed
First Posted : February 29, 2016
Last Update Posted : January 26, 2018
Sponsor:
Information provided by (Responsible Party):
Nehad Nasef, Mansoura University Children Hospital

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.

Condition or disease Intervention/treatment Phase
Oxidative Stress in Preterm Infants Other: Light-protection of TPN solutions Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Impact of Protecting TPN Solution From Light on the Oxidant-antioxidant State of Preterm Infant
Actual Study Start Date : January 1, 2014
Actual Primary Completion Date : January 1, 2018
Actual Study Completion Date : January 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antioxidants

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.




Primary Outcome Measures :
  1. Oxidant-antioxidant state [ Time Frame: 7 days ]
    Measurement of urinary peroxides and serum GSH/GSSG ratio


Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Preterm infant less than 32 weeks gestational age

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02694510


Locations
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Egypt
Mansoura University Children Hospital
Mansoura, El Dakahlya, Egypt, 35111
Sponsors and Collaborators
Mansoura University Children Hospital

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Responsible Party: Nehad Nasef, Assistant professor, PhD, Mansoura University Children Hospital
ClinicalTrials.gov Identifier: NCT02694510     History of Changes
Other Study ID Numbers: MS/299
First Posted: February 29, 2016    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Nehad Nasef, Mansoura University Children Hospital:
Preterm infants
Oxidative stress
Parenteral nutrition
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Pharmaceutical Solutions