Actively Recruiting

Phase Not Applicable
All Genders
NCT06219525

Higher and Standard Doses of Enteral Zinc Supplementation in Very Preterm Infants

Led by Prince of Songkla University · Updated on 2024-09-19

120

Participants Needed

1

Research Sites

195 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this randomized clinical trial is to compare the effect of higher (10 mg per day) versus standard (1 mg per day) doses of zinc supplementation The main questions it aims to answer are: * Growth velocities and delta z-scores during the date of start intervention until the end of the time interval (at least 2 weeks of intervention on date of 44 weeks of postmenstrual age or discharge whichever came first) in very preterm infants with a birthweight less than1800 grams. * Growth and neurodevelopment at 24 months postnatal age

CONDITIONS

Official Title

Higher and Standard Doses of Enteral Zinc Supplementation in Very Preterm Infants

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Very preterm neonates (gestational age 24 0/7-32 6/7 weeks) admitted consecutively in the NICU and NMCU
  • Birth weight between 401 and 1800 grams
  • Body weight at enrollment less than 800 grams
  • Stable neonates and receiving full enteral feeding (150 mL/kg/day) for at least a few days
Not Eligible

You will not qualify if you...

  • Outborn neonates admitted to the study center after 7 days of life
  • Congenital infections
  • Malformations, syndromes, or genetic defects
  • Proven sepsis, necrotizing enterocolitis, or death before enrollment
  • Gastrointestinal surgery or high gastrointestinal fluid output
  • Unstable neonates during weighing or with chest drainage
  • Neonates requiring diuretics for more than 7 days
  • Severe birth asphyxia (5-minute Apgar score less than 4)
  • Parents' decision not to participate

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Songklanagarind Hospital, Prince of Songkla University

Hat Yai, Changwat Songkhla, Thailand, 90110

Actively Recruiting

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Research Team

A

Anucha Thatrimontrichai, MD

CONTACT

B

Boonwiroj Jitwilertrat, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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