Caffeine treatment for late preterm infants with breathing difficulties
Caffeine for Late Preterm Infants: A Double Blind Randomized Controlled Trial
This study tests if giving caffeine to late preterm infants with breathing problems can help them breathe better and shorten their hospital stay.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 134 (estimated) |
| Ages | 1 Day to 3 Days |
| Sex | All |
| Sponsor | Ministry of Health, Saudi Arabia Government |
| Locations | 2 sites (Madinah, Medina Region and 1 other locations) |
| Trial ID | NCT06026163 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of caffeine citrate on late preterm infants experiencing respiratory distress. Infants will be randomly assigned to receive either caffeine or a placebo, with the aim of assessing how caffeine impacts their respiratory support needs, hospital stay duration, and frequency of apnea events. The caffeine treatment group will receive a loading dose followed by a maintenance dose until they no longer require respiratory support. The study is designed to be double-blinded to ensure unbiased results.
Who should consider this trial
Good fit: Ideal candidates are late preterm infants aged 34 to 36 weeks gestation who are experiencing respiratory distress and require respiratory support.
Not a fit: Patients who are late preterm but do not require significant respiratory support or have non-respiratory issues will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the duration of respiratory support and hospital stays for late preterm infants.
How similar studies have performed: Previous studies have shown promising results with caffeine therapy in preterm infants, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Madinah, Medina Region and 1 other locations
- King Salman Bin Abdulaziz Medical City — Madinah, Medina Region, Saudi Arabia (Recruiting)
- King Salman Bin Abdulaziz Medical City — Madinah, Saudi Arabia (Recruiting)
Study contacts
- Principal investigator: Nehad Nasef — Neonatology Consultant
- Study coordinator: Ohoud Almoualled, Dr
- Email: o.doc2or@gmail.com
- Phone: +966500550679
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.