Caffeine as an Adjuvant Therapy for Late Preterm Infants With Respiratory Distress
Launched by MINISTRY OF HEALTH, SAUDI ARABIA · Sep 3, 2023
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effects of caffeine on late preterm infants who are having trouble breathing. Researchers believe that caffeine might help these babies by improving their ability to breathe, reducing episodes where they stop breathing (called apnea), and potentially shortening their hospital stay. The trial specifically looks at babies born between 34 and 36 weeks of gestation who need help breathing, such as through a ventilator or extra oxygen.
If your baby meets the criteria, they may be eligible to participate in this study. Participants will receive caffeine treatment and the researchers will track how long they need respiratory support and how long they stay in the hospital. The trial is currently recruiting infants aged 1 to 3 days, regardless of gender. It's important to know that some babies will not be eligible, such as those with certain health conditions or who are not experiencing respiratory issues. Overall, this study aims to find out if caffeine can be a helpful addition to the care of late preterm infants with breathing difficulties.
Gender
ALL
Eligibility criteria
- 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
About Ministry Of Health, Saudi Arabia
The Ministry of Health of Saudi Arabia is a pivotal governmental body dedicated to enhancing public health and advancing healthcare services across the Kingdom. As a clinical trial sponsor, it is committed to facilitating innovative research and development in medical sciences, ensuring that clinical studies adhere to the highest ethical and regulatory standards. By promoting collaboration with local and international researchers, the Ministry aims to generate valuable insights that contribute to evidence-based healthcare policies, improve patient outcomes, and address the specific health needs of the Saudi population.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Medina, , Saudi Arabia
Patients applied
Trial Officials
Nehad Nasef
Principal Investigator
Neonatology Consultant
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported