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

Recruiting now · Not applicable

Conditions studied: Very Preterm Infants, Zinc Deficiency

In brief

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

Key facts

Study ID

NCT06219525

Run by

Prince of Songkla University

People needed

120

Starts

2024-04-02

Expected to finish

2027-12-31

Last updated by the study team

2024-09-19

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Very preterm neonates (gestational age [GA]: 24 0/7-32 6/7 weeks and BW: 401-1800 grams) were consecutively admitted in the NICU and NMCU
• Body weight at enrollment less than 800 grams
• Stable neonates and full enteral feeding (150 mL/kg/day) at least for a few days

You may not qualify if…

• Outborn neonate who was admitted in study center after 7 days of life
• Congenital infections
• Malformations, syndromes, or genetic defects
• Evidence of culture proven sepsis or necrotizing enterocolitis or death diagnosed before enrollment
• Gastrointestinal (GI) surgery or high GI fluid output (usually ileostomy losses)
• Unstable neonate during weighing including on intercostal drainage tube or drainage
• Neonates need diuretics more than 7 days
• Severe birth asphyxia (5-minute Apgar score less than 4)
• Parents' decision not to participate the study

Where it is running

• Songklanagarind Hospital, Prince of Songkla University — Hat Yai, Changwat Songkhla, Thailand (enrolling)

Full record on ClinicalTrials.gov

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