Skip to main content
OpenTrials
Completed

NCT Number: NCT05311540

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

* 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Preterm Infant Effect of Drugs Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases Zinc Deficiency Disease

Age range

7 day–9 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Izmir Democracy University Faculty of Medicine

Izmir, 35290, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

zinc sulfate

Drug

Primary outcomes

  1. Incidence of feeding intolerance

    Time frame: through study completion, an average of 6 months

Secondary outcomes

  1. Duration of hospitalization

    Time frame: through study completion, an average of 6 months

  2. Number of participants with necrotising enterocolitis (stage≥2)

    Time frame: through study completion, an average of 6 months

  3. Incidence of mortality

    Time frame: through study completion, an average of 6 months

  4. Number of participants with late onset sepsis

    Time frame: through study completion, an average of 6 months

  5. Number of participants with retinopathy of prematurity

    Time frame: through study completion, an average of 6 months

  6. Number of participants with bronchopulmonary dysplasia

    Time frame: through study completion, an average of 6 months

Sponsors and collaborators

Lead sponsor

Zekai Tahir Burak Women's Health Research and Education Hospital

Other

Collaborators

  • Ankara City Hospital Bilkent

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 5, 2022
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.