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New treatment option for Premature Infant Disease
Official title Caffeine Citrate in Preterm Infants at Risk of Apnea in Zambia
ClinicalTrials.gov ID: NCT06518603
What this study is testing
What is Caffeine citrate 20mg/kg/day?
Caffeine citrate 20mg/kg/day is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for premature infant disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to learn if caffeine citrate prevents apneic events that result in sick visits in moderately preterm infants after discharge from the hospital. It will also learn if the use of caffeine leads to better developmental outcomes at 12 months of age.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 to 12
You may be able to join if
- Newborns:
- 29 0/7 to 33 6/7 weeks GA (or with a birth weight 1.0 to 2.0 kg if pregnancy dating is unreliable) admitted to the UTH NICU,
- On methylxanthines with plans to discontinue on methylxanthine,
- Off oxygen therapy for \>48 hours at the time of evaluation for eligibility,
- Receiving full daily feeds,
You likely can't join if
- Newborns with neuromuscular conditions affecting respiration,
- Major congenital malformations and genetic disorders,
- Unable to obtain parental or guardian consent
See the full eligibility criteria
- Newborns:
- 29 0/7 to 33 6/7 weeks GA (or with a birth weight 1.0 to 2.0 kg if pregnancy dating is unreliable) admitted to the UTH NICU,
- On methylxanthines with plans to discontinue on methylxanthine,
- Off oxygen therapy for \>48 hours at the time of evaluation for eligibility,
- Receiving full daily feeds,
- Deemed stable and ready to go off caffeine as recommended by the Neonatologist
- 18+ years of age (parent)
- Newborns with neuromuscular conditions affecting respiration,
- Major congenital malformations and genetic disorders,
- Unable to obtain parental or guardian consent
The study team makes the final eligibility decision.
Where it's taking place
- Lusaka, Lusaka Province, Zambia
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, 0 days to 12 months. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lusaka, Lusaka Province, Zambia. 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.