Light Protection of TPN and Oxidative Stress in Preterm Infants
Anahtar kelimeler
Öz
Açıklama
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.
Tarih
| Son Doğrulandı: | 12/31/2017 |
| İlk Gönderilen: | 02/15/2016 |
| Tahmini Kayıt Gönderildi: | 02/22/2016 |
| İlk Gönderilen: | 02/28/2016 |
| Son Güncelleme Gönderildi: | 01/23/2018 |
| Son Güncelleme Gönderildi: | 01/25/2018 |
| Fiili Çalışma Başlangıç Tarihi: | 12/31/2013 |
| Tahmini Birincil Tamamlanma Tarihi: | 12/31/2017 |
| Tahmini Çalışma Tamamlanma Tarihi: | 12/31/2017 |
Durum veya hastalık
Müdahale / tedavi
Other: Light-protection of TPN solutions
Evre
Kol Grupları
| Kol | Müdahale / tedavi |
|---|---|
| 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. | |
| Active Comparator: Light-exposure TPN bags and infusion sets will be exposed to light throughout the study period. |
Uygunluk kriterleri
| Çalışmaya Uygun Cinsiyetler | All |
| Sağlıklı Gönüllüleri Kabul Ediyor | Evet |
| Kriterler | Inclusion Criteria: - Preterm infant less than 32 weeks gestational age Exclusion Criteria: - Infant with major congenital anomalies - Infant of diabetic or hypertensive mother |
Sonuç
Birincil Sonuç Ölçütleri
1. Oxidant-antioxidant state [7 days]
İkincil Sonuç Ölçütleri
1. Death and/or Bronchopulmonary dysplasia [60 days]
2. Necrotizing enterocolitis as Bell's stage 2 or more [60 days]
3. Sepsis [60 dyas]
4. Retinopathy of prematurity pre-threshold and threshold stages [60 dyas]
5. Time to full feeding [30 days]
6. Duration of respiratory support [60 days]
7. Neonatal cholestasis [60 days]
8. Metabolic disturbance [60 days]
9. Length of hospital stay [60 days]
