Actively Recruiting
Caffeine as an Adjuvant Therapy for Late Preterm Infants With Respiratory Distress
Led by Ministry of Health, Saudi Arabia · Updated on 2025-06-27
134
Participants Needed
2
Research Sites
220 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Caffeine as an Adjuvant Therapy for Late Preterm Infants With Respiratory Distress
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newborn infants at gestational age 34 0/7 through 36 6/7
- Presented with respiratory distress
- Require respiratory support such as invasive mechanical ventilation, non-invasive positive pressure ventilation, or nasal cannula with FIO2 over 50% to maintain oxygen saturation between 90-95%
You will not qualify if you...
- Late preterm infants admitted for reasons other than respiratory problems
- Late preterm infants needing nasal cannula with less than 50% oxygen by 4 hours of age
- Newborn infants with congenital malformations or chromosomal anomalies
- Infants with pulmonary hypertension requiring medical treatment
- Late preterm infants with a history of maternal substance abuse
AI-Screening
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Trial Site Locations
Total: 2 locations
1
King Salman Bin Abdulaziz Medical City
Madinah, Medina Region, Saudi Arabia, 42319
Actively Recruiting
2
King Salman Bin Abdulaziz Medical City
Madinah, Saudi Arabia
Actively Recruiting
Research Team
O
Ohoud Almoualled, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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