Status:
RECRUITING
Caffeine as an Adjuvant Therapy for Late Preterm Infants With Respiratory Distress
Lead Sponsor:
Ministry of Health, Saudi Arabia
Conditions:
Prematurity
Respiratory Disease
Eligibility:
All Genders
1-3 years
Phase:
PHASE2
PHASE3
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...
Detailed Description
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 fo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT06026163
Start Date
October 12 2023
End Date
January 1 2028
Last Update
June 27 2025
Active Locations (2)
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1
King Salman Bin Abdulaziz Medical City
Madinah, Medina Region, Saudi Arabia, 42319
2
King Salman Bin Abdulaziz Medical City
Madinah, Saudi Arabia