Higher and Standard Doses of Enteral Zinc Supplementation in Very Preterm Infants
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorPrince of Songkla University
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Higher dose of enteral zinc
Dietary supplementHigher dose of zinc sulfate 10 mg/day; each 1 mL contains 10 mg of elemental zinc (osmolality 450 Osm/kg H2O). After randomization, nurses blinded to the study aims administered the assigned preparation 1 mL via tuberculin syringe, once daily, 1 hour after feeding. Zinc sulphate oral solution was prepared by the pharmaceutical compounding unit in the hospital. The supplement was given again to subjects who vomited within 15 minutes after the administration. All episodes of vomiting were reported on the record form. Vomiting episodes within 15 minutes were recorded. The supplement assigned was at discharge or at 44 weeks of postmenstrual age whichever came first. Both groups received multivitamin (MTV) products and iron supplement as routine preterm care.
Standard dose of enteral zinc
Dietary supplementStandard dose of zinc sulfate 1 mg/day; each 1 mL contains 1 mg of elemental zinc (osmolality 45 Osm/kg H2O). After randomization, nurses blinded to the study aims administered the assigned preparation 1 mL via tuberculin syringe, once daily, 1 hour after feeding. Zinc sulphate oral solution was prepared by the pharmaceutical compounding unit in the hospital. The supplement was given again to subjects who vomited within 15 minutes after the administration. All episodes of vomiting were reported on the record form. Vomiting episodes within 15 minutes were recorded. The supplement assigned was discontinued at discharge or at 44 weeks of postmenstrual age whichever came first. Both groups received multivitamin (MTV) products and iron supplement as routine preterm care.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Higher dose of enteral zincActive comparator 1 intervention
Group B: Standard dose of enteral zincPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Weight velocity 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)
Weight velocity was calculated during the beginning of study (time1 \[T1\], Weight1 \[W1\]) until the end of the time interval (time2 \[T2\], Weight \[W2\]). Weight gain (grams per kilogram per day) was calculated during the period using the 2-point average method \[1000\*(W2-W1)\]/\[(W2+W1)/2)\*(T2-T1)\]. Weight delta z-scores of were calculated weight z-scores at T2 minus weight z-scores at T1 from the Fenton's Growth Chart
Time frame
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)2
Length velocity 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)
Length velocity was calculated during the beginning of study (time1 \[T1\], Length1 \[L1\]) until the end of the time interval (time2 \[T2\], Length \[L2\]). Length velocities (centimeters per kilogram per day) was calculated during the period using the 2-point average method \[1000\*(L2-L1)\]/\[(L2+L1)/2)\*(T2-T1)\] Length delta z-scores were calculated length z-scores at T2 minus length z-scores at T1 from the Fenton's Growth Chart
Time frame
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)3
Head circumference (HC) velocity 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)
HC velocity was calculated during the beginning of study (time1 \[T1\], HC1) until the end of the time interval (time2 \[T2\], HC2). HC velocities (centimeters per kilogram per day) was calculated during the period using the 2-point average method \[1000\*(HC2-HC1)\]/\[(HC2+HC1)/2)\*(T2-T1)\] HC delta z-scores were calculated HC z-scores at T2 minus HC z-scores at T1 from the Fenton's Growth Chart
Time frame
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)Secondary outcomes
1
Growth at 24 months postnatal age (PNA)
Growth \[at 24 months PNA, 20-24 months corrected age\]) was assessed by corrected age
Time frame
At 24 months PNA (20-24 months corrected age)2
Neurodevelopment at 24 months postnatal age (PNA)
Neurodevelopmental outcomes (Bayley-III tests, were evaluated by only dedicated clinical psychologists at 24 months PNA \[20-24 months corrected age\]) were assessed by corrected age
Time frame
At 24 months PNA (20-24 months corrected age)Sponsors and contacts
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Source ClinicalTrials.gov