A Trial on Different Dosages of Vitamin D in Preterm Infants With Late-onset Sepsis

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized controlled trial (RCT) to evaluate the influence of different doses of vitamin D3 (800 IU/d versus 400 IU/d), on serum levels of interleukin (IL)-6, TNF-alpha and C- reactive (CRP) in premature infants with clinical evidence of late-onset sepsis and to assess its influence on clinical outcomes of these infants.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mansoura University Children Hospital
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

• Preterm Infants (28-37 wk gestational age)

• Late-onset sepsis defined as clinical signs suggestive of infection after 72 h of birth. Clinical sepsis will be defined as the presence of three or more of the following categories of clinical signs:

1. Temperature instability (hypothermia, hyperthermia);

2. Respiratory (grunting, intercoastal retraction, apnea, tachypnea, cyanosis);

3. Neurologic (hypotonia, lethargy, seizures);

4. Gastrointestinal (feeding intolerance, abdominal distension).

Exclusion Criteria:

• Major congenital anomalies.

• Chromosomal anomalies.

• Known inborn error(s) of metabolism