A Phase 4 interventional study of Zinc Sulfate in Preterm Infant, Effect of Drugs and Zinc Deficiency Disease, sponsored by Zekai Tahir Burak Women's Health Research and Education Hospital. Completed at 1 site in Turkey. Open to participants aged 7 Days to 9 Days. Per ClinicalTrials.gov, last updated 2023-02-08.
Sponsored by Zekai Tahir Burak Women's Health Research and Education Hospital · Phase 4, Interventional, and Prevention
Background and Objectives: Preterm infants have high zinc (Zn) requirements and are generally believed to be in a negative Zn balance in the early period of life. In this study, we aimed to investigate the effect of high dose Zn supplementation in very low birth weight (VLBW) infants on feeding intolerance and development of mortality and/or morbidities including necrotizing enterocolitis (NEC), late-onset sepsis (LOS).
Methods: This is a prospective randomized trial. VLBW preterm infants with gestational age of \<32 weeks were randomly allocated on the seventh day of life to receive extra amount of supplemental zinc along with the enteral feedings or not, besides regular low dose supplementation, from enrollment until discharge. Outcome measures were feeding intolerance, NEC (stage≥2), LOS and mortality.
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This study's enrollment of 195 is above the median of 84 across 1,666 interventional studies indexed under Premature Birth.
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Exclusion Criteria:
9 mg/day Zinc suspension via og tube along with the routinely used standard multivitamin product containing 3 mg daily dose of Zn, started on day 7 until discharge from hospital
Drug: Zinc Sulfate
These infants received only standard commercial multivitamin product containing 3 mg daily dose of Zn
Incidence of feeding intolerance
Time frame: through study completion, an average of 6 months
Duration of hospitalization
Time frame: through study completion, an average of 6 months
Number of participants with necrotising enterocolitis (stage≥2)
Time frame: through study completion, an average of 6 months
Incidence of mortality
Time frame: through study completion, an average of 6 months
Number of participants with late onset sepsis
Time frame: through study completion, an average of 6 months
Number of participants with retinopathy of prematurity
Time frame: through study completion, an average of 6 months
Number of participants with bronchopulmonary dysplasia
Time frame: through study completion, an average of 6 months
Plan to share: No
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This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Zinc Sulfate
Zekai Tahir Burak Women's Health Research and Education Hospital