NCT06026163 Caffeine as an Adjuvant Therapy for Late Preterm Infants With Respiratory Distress
| NCT ID | NCT06026163 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Ministry of Health, Saudi Arabia |
| Condition | Prematurity |
| Study Type | INTERVENTIONAL |
| Enrollment | 134 participants |
| Start Date | 2023-10-12 |
| Primary Completion | 2027-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 134 participants in total. It began in 2023-10-12 with a primary completion date of 2027-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Nehad Nasef
PRINCIPAL INVESTIGATOR
Neonatology Consultant
Frequently Asked Questions
Who can join the NCT06026163 clinical trial?
This trial is open to participants of all sexes, aged 1 Day or older, up to 3 Days, studying Prematurity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06026163 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06026163 currently recruiting?
Yes, NCT06026163 is actively recruiting participants. Contact the research team at o.doc2or@gmail.com for enrollment information.
Where is the NCT06026163 trial being conducted?
This trial is being conducted at Madinah, Saudi Arabia, Madinah, Saudi Arabia.
Who is sponsoring the NCT06026163 clinical trial?
NCT06026163 is sponsored by Ministry of Health, Saudi Arabia. The principal investigator is Nehad Nasef at Neonatology Consultant. The trial plans to enroll 134 participants.