Comparison Between Effect of Conventional, Intensive and Light Emitting Diodes (LED) Phototherapy on Oxidative Stress Among Neonates With Unconjugated Hyperbilirubinemia

Oxidative Stress Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03074292
• Other study ID #: 00006444
• Status: Active, not recruiting
• Phase: N/A
• First received: February 16, 2017
• Last updated: March 7, 2017
• Start date: December 2013
• Est. completion date: March 2017

Study information

• Verified date: March 2017
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the present study is to test a hypothesis assuming that phototherapy might have an effect on oxidant/antioxidant status in term and late-preterm neonates with unconjugated hyperbilirubinemia.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

Inclusion Criteria:

• Term and late-preterm neonates (=35weeks) according to the guidelines of the American Academy of Pediatrics (2004) which stated that gestational ages of newborns were determined according to the first day of the mother's last menstrual period (by the mother's statement) and were additionally confirmed by the Ballard scoring system (Ballard et al., 1991) and antenatal ultrasonographic estimation or obstetric records if present.

• Clinical significant indirect hyperbilirubinemia requiring phototherapy in the first week of life.

• Normal blood counts and peripheral blood smears

• Normal reticulocytic count.

• Breast fed newborn.

Exclusion Criteria:

• Those in whom the total serum bilirubin (TSB) level rose by more than 5 mg/dl per day or was higher than 20 mg/dl within the first 24 hours after birth were excluded from the study.

• Infant of diabetic mothers.

• Maternal eclampsia-preeclampsia.

• Birth asphyxia

• Sepsis

• congenital anomalies.

• Direct Coombs`test positive

• Pathological causes of hyperbilirubinemia.

• Enclosed hemorrhage.

• Hemolytic type of hyperbilirubinemia due to blood group or Rh incompatibility.

Related Conditions & MeSH terms

• Hyperbilirubinemia
• Hyperbilirubinemia, Neonatal
• Neonatal Hyperbilirubinemia
• Oxidative Stress
• Phototherapy Complication

Intervention

Procedure:
• phototherapy
estimate oxidative stress and trace elements in neonates with unconjugated hyperbilirubinemia after exposure to phototherapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rania Ali El-Farrash

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of types of phototherapy on change in total antioxidant capacity (TAC)	This will be determined by: Measure TAC (mmol/L) before and after phototherapy; Compare results of TAC (mmol/L) before and after phototherapy.	2 days
Primary	Effect of types of phototherapy on change in malonaldehyde (MDA)	This will be determined by: Measure MDA (nmol/L) before and after phototherapy; Compare results of MDA (nmol/L) before and after phototherapy.	2 days
Primary	Effect of types of phototherapy on change in nitric oxide (NO)	This will be determined by: Measure NO (umol/L) before and after phototherapy; Compare results of NO (umol/L) before and after phototherapy.	2 days
Secondary	Effect of types of phototherapy on change in serum iron (Fe)	This will be determined by: Measure serum Fe before and after phototherapy; Compare results of serum Fe before and after phototherapy.	2 days
Secondary	Effect of types of phototherapy on change in serum copper (Cu)	This will be determined by: Measure serum Cu before and after phototherapy; Compare results of serum Cu before and after phototherapy.	2 days
Secondary	Effect of types of phototherapy on change in serum zinc (Zn)	This will be determined by: Measure serum Zn before and after phototherapy; Compare results of serum Zn before and after phototherapy.	2 days
Secondary	Effect of types of phototherapy on change in serum calcium (Zn)	This will be determined by: Measure serum Ca before and after phototherapy; Compare results of serum Ca before and after phototherapy.	2 days