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New treatment option for Very Preterm Infants
Official title Higher and Standard Doses of Enteral Zinc Supplementation in Very Preterm Infants
ClinicalTrials.gov ID: NCT06219525
What this study is testing
- What it's testing
- 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
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join 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 likely can't join 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
See the full eligibility criteria
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Hat Yai, Changwat Songkhla, Thailand
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hat Yai, Changwat Songkhla, Thailand. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.