Caffeine as an Adjuvant Therapy for Late Preterm Infants With Respiratory Distress
Recruiting
Phase 2
Phase 3
Interventional Study
Prematurity
Respiratory Disease
Ventilator Lung; Newborn
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 1 Day – 3 Days
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 134 (estimated)
- Sponsor
- Ministry of Health, Saudi Arabia · Government
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About This Trial
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 …
Trial Locations
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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 req…
Contacts