Zinc Supplementation In Very Low Birth Weight Infants-A Randomised Controlled Trial

Phase 4

Completed

• Conditions: Preterm Infant; Effect of Drugs; Zinc Deficiency Disease
• Interventions: Drug: Zinc Sulfate

• Registration Number: NCT05311540
• Lead Sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital

Brief Summary

* Zinc (Zn) is a structural component of human body and is a crucial element for a wide variety of cascades that take place in almost all organ systems.

* Due to many reasons, preterm infants are generally believed to be naturally in a negative Zn balance during the early periods of life.

* Regulation of intestinal Zn absorption of preterms is unrelated to infant's Zn status.

* There still is a lack of knowledge in the possible relation of Zn deficiency and development of NEC and/or feeding intolerance in preterm infants.

* Even if Zn is studied as an adjunct treatment for neonates and young infants with sepsis and found to reduce treatment failure in these high risk population, data in preventing infectious diseases in preterm infants is still lacking.

Detailed Description

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.

Study Timeline

• Study Start: 2014-03-14
• Primary Completion: 2015-03-02
• Study Completion: 2015-04-20
• Study First Submitted: 2019-05-19
• Study First Submitted QC: 2022-03-25
• Study First Posted: 2022-04-05
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-03
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 195

Inclusion Criteria

• < 32 weeks gestational age and/or <1500 gr birth weight
• Born in the study hospital
• Being able to be fed enterally, even in very small amounts, regardless of the volume of the nutrient

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Exclusion Criteria

• Major congenital malformations and/or critical congenital heart defects
• Born in another hospital
• Severe birth asphyxia
• Severe sepsis
• Previous early-onset NEC history
• Infants on the intervention arm who did not continue Zinc supplementation during the study period
• Hemodynamically unstability
• Infants nil per os
• No consent from the family
• Death before the 7th day of life

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Zinc intervention	Zinc Sulfate	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

Primary Outcome Measures

Name	Time	Method
Incidence of feeding intolerance	through study completion, an average of 6 months

Secondary Outcome Measures

Name	Time	Method
Incidence of mortality	through study completion, an average of 6 months
Number of participants with late onset sepsis	through study completion, an average of 6 months
Number of participants with retinopathy of prematurity	through study completion, an average of 6 months
Duration of hospitalization	through study completion, an average of 6 months
Number of participants with necrotising enterocolitis (stage≥2)	through study completion, an average of 6 months
Number of participants with bronchopulmonary dysplasia	through study completion, an average of 6 months

Trial Locations

Locations (1)

Izmir Democracy University Faculty of Medicine; 🇹🇷 Izmir, Turkey