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Clinical Trials/CTRI/2015/06/005904
CTRI/2015/06/005904
Recruiting
Phase 2

Population Pharmacokinetic and Pharmacodynamic study of Aminophylline and Caffeine in premature newborns with Apnea

Kasturba Medical College0 sites402 target enrollmentTBD

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
Kasturba Medical College
Enrollment
402
Status
Recruiting
Last Updated
4 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • 1\. Less than or equal to 34 completed weeks of gestation with less than or equal to 6 apneas in 24 hours , or
  • 2\. Any preterm newborn with apneic episode requiring bag and mask ventilation for termination of apnea.

Exclusion Criteria

  • 1\.Neonates with secondary causes of apnea ( hypoglycemia , hypocalcemia , hypothermia, seizures , sepsis , Intra Ventricular Hemorrhage , depression from medications)
  • 2\.Neonates who are on other drugs that potentiates the toxicity of Methylxanthines
  • 3\.Preterm neonates with major congenital anomalies
  • 4\.Significant PDA as a cause of apnea (defined as \- ductus diameter of 1\.5mm and absent/ retrograde diastolic flow in the post\-ductal aorta)

Outcomes

Primary Outcomes

Not specified

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