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Caffeine as an Adjuvant Therapy for Late Preterm Infants With Respiratory Distress

RecruitingPhase 2, Phase 3Ages 1 Day - 3 DaysAllMinistry of Health, Saudi Arabia
NCT06026163 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Use of caffeine citrate in late-preterm infants with respiratory distress is questionable. Oliphant and colleagues found in a recently published study that caffeine therapy use in late-preterm infants at a loading dose of 20 and 40 mg/kg and maintenance dose of 10 and 20 mg/kg/day reduces the incidence of intermittent hypoxia events by 61 and 67% respectively. The investigators hypothesized that caffeine will improve respiratory drive, prevent apnea, shorten the hospital stay and improve arousal state in late preterm infants. The investigators aim to study the effect of caffeine citrate on late preterm babies as regard duration of respiratory support, duration of hospital stay, respiratory morbidity, incidence and frequency of apnea.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Newborn infants at gestational age 34 0/7 through 36 6/7 * Presented with respiratory distress * Require respiratory support in the form of any of the following : A) Invasive mechanical ventilation, B) Non-invasive positive pressure ventilation, C) Nasal cannula with FIO2 requirement over 50% to keep pre-ductal saturation between 90-95%. Exclusion Criteria: 1 - Late preterm admitted for non-respiratory etiologies 2- Late preterm infants requiring nasal cannula on less than 50% FIO2 by 4 hours of age as they are less likely to require respiratory support for a long time. 3- Newborn infants with congenital malformations and chromosomal anomalies. 4- Infants with echocardiographic evidence of PPHN requiring medical intervention. 5- Late preterm with history of maternal substance abuse
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What it tests

  • Caffeine citrate
  • Placebo
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Where

2 sites
King Salman Bin Abdulaziz Medical City
Madinah, Saudi Arabia
King Salman Bin Abdulaziz Medical City
Madinah, Saudi Arabia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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