Caffeine citrate
DrugCaffeine citrate in loading dose 20 mg/kg (equivalent for 10 mg/kg caffeine base) and maintenance dose 10 mg/kg/day (equivalent for 5 mg/kg caffeine base)
Other names: Intervention group
NCT Number: NCT06026163
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.
Interested in participating?
Request Info1 day–3 day
All sexes
Interventional
Phase 2 / Phase 3
King Salman Bin Abdulaziz Medical City, Madinah, Medina Region, Saudi Arabia
late preterm infants will be randomized in a blinded manner to receive either caffeine in loading dose 20 mg/kg (equivalent for 10 mg/kg caffeine base) and maintenance dose 10 mg/kg/day (equivalent for 5 mg/kg caffeine base) in Caffeine treatment group, or equivalent volume of saline in the placebo group. Caffeine will be continued until infants get off all forms of respiratory support.
Preparation of caffeine and placebo will be performed by a designated pharmacist who is not part of the study. Parents and investigators will be remained blinded to the administered medications throughout the study period.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
Caffeine citrate in loading dose 20 mg/kg (equivalent for 10 mg/kg caffeine base) and maintenance dose 10 mg/kg/day (equivalent for 5 mg/kg caffeine base)
Other names: Intervention group
Equivalent volume of saline
Other names: Saline
Time frame: 28 days
cumulative duration of mechanical ventilation, non-invasive positive pressure ventilation and nasal cannula therapy (days)
Time frame: 28 gays
the cessation of breathing for more than 20 seconds or cessation of breathing for accompanied by bradycardia or desaturation
Time frame: 28 days
need of re-intubation within 72 h of extubation from mechanical ventilation
Time frame: 28 days
Days of caffeine treatment
Time frame: 28 days
days of hospital admission
Time frame: 28 days
days to reach full enteral feeds
Time frame: 28 days
Tachycardia, irritability, feeding intolerance, hypertension
Time frame: 28 days
Caffeine withhold for suspected side effects
Time frame: 28 days
Weight gain per day (gram)
Time frame: 28 days
Death before hospital discharge
Time frame: 28 days
Readmission to the hospital with respiratory related symptoms within 48 hours of hospital discharge
Time frame: 28 days
Days of apnea
Contact information is provided by the study sponsor or research team.
Ministry of Health, Saudi Arabia
Other Gov
Caffeine for Late Preterm Infants: A Double Blind Randomized Controlled Trial
Acronym: CAT/LPT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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