A Phase 2/3 interventional study of Caffeine citrate and Placebo in Prematurity, Respiratory Disease and Ventilator Lung; Newborn, sponsored by Ministry of Health, Saudi Arabia. Recruiting at 2 sites in Saudi Arabia. Open to participants aged 1 Day to 3 Days. Per ClinicalTrials.gov, last updated 2025-06-27.
Sponsored by Ministry of Health, Saudi Arabia · Phase 2/3, Interventional, and Treatment
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.
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.
2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
This study's planned enrollment of 134 is above the median of 84 across 1,666 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →Ministry of Health, Saudi Arabia is the lead sponsor of 21 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
Infants receive either 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).
Drug: Caffeine citrate
Infants received equivalent volume of saline.
Other: Placebo
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)
Also known as: Intervention group
Equivalent volume of saline
Also known as: Saline
Duration of respiratory support
cumulative duration of mechanical ventilation, non-invasive positive pressure ventilation and nasal cannula therapy (days)
Time frame: 28 days
Episodes of apnea
the cessation of breathing for more than 20 seconds or cessation of breathing for accompanied by bradycardia or desaturation
Time frame: 28 gays
Failure of extubation
need of re-intubation within 72 h of extubation from mechanical ventilation
Time frame: 28 days
Duration of caffeine
Days of caffeine treatment
Time frame: 28 days
Length of hospital stay
days of hospital admission
Time frame: 28 days
Time to full enteral and oral feeding
days to reach full enteral feeds
Time frame: 28 days
Adverse effects of caffeine use
Tachycardia, irritability, feeding intolerance, hypertension
Time frame: 28 days
Caffeine withhold
Caffeine withhold for suspected side effects
Time frame: 28 days
Weight gain per day
Weight gain per day (gram)
Time frame: 28 days
Mortality
Death before hospital discharge
Time frame: 28 days
Readmission rate
Readmission to the hospital with respiratory related symptoms within 48 hours of hospital discharge
Time frame: 28 days
Days of apnea
Days of apnea
Time frame: 28 days
Plan to share: Yes — Data obtained through this study may be provided to qualified researchers for research and scientific purposes (i.e conduction of meta-analysis or systematic review). Data or samples shared will be coded, with no protected health information included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
Supporting information: Study protocol
Time frame: Data requests can be submitted starting 3 months after article publication and the data will be made accessible for up to 12 months. Extensions will be considered on a case-by-case basis."
Access criteria: Access to raw data (no protected health information) can be requested by qualified researchers for scientific purposes, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA)
Started Oct 2023 (actual). Primary completion is estimated for Oct 2027, 48 months after the start.
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Studies of the drug tested here: Caffeine citrate
Ministry of Health, Saudi Arabia