Caffeine treatment for premature infants at birth
The Caffeine Therapy in the Fetal to Neonatal Transition in Preterms
This study is testing if giving caffeine to premature babies right after birth can help them breathe better and need less help with breathing compared to starting the caffeine treatment a day later.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | N/A to 2 Hours |
| Sex | All |
| Sponsor | Hospital de Clinicas de Porto Alegre Academic / other |
| Locations | 1 site (Porto Alegre, Rio Grande do Sul) |
| Trial ID | NCT05454332 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of administering caffeine to premature newborns weighing less than 1250 grams within the first two hours of life, compared to starting treatment at 24 hours. The goal is to determine if early caffeine administration can reduce the need for intubation and decrease ventilation time in these infants. Participants will be randomly assigned to either the early treatment group or a control group receiving caffeine later. The research aims to enhance the quality of care for preterm infants by identifying the optimal timing for caffeine therapy.
Who should consider this trial
Good fit: Ideal candidates are premature newborns with a birth weight of less than 1250 grams who are not intubated at birth.
Not a fit: Patients who are intubated at birth or have major congenital malformations or genetic syndromes will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved respiratory outcomes and neurodevelopmental benefits for premature infants.
How similar studies have performed: Previous observational studies suggest that early caffeine administration may be beneficial, but this specific approach is being further evaluated in a controlled setting.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Premature newborns with birth weight less than 1250 grams * Who are not intubated in the delivery room Exclusion Criteria: * Premature newborns from other hospitals * Presence of a major congenital malformation or genetic syndrome
Where this trial is running
Porto Alegre, Rio Grande do Sul
- Hospital de Clínicas de Porto Alegre — Porto Alegre, Rio Grande do Sul, Brazil (Recruiting)
Study contacts
- Study coordinator: Gabriela Trindade
- Email: gabs.trindade@gmail.com
- Phone: +55 51 985002009
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.