A Randomized Controlled Trial Comparing Serum Theophylline Levels and Side effects between Two Regimens of Aminophylline in Preterm Infants

Not Applicable

Completed

• Conditions: ApneaTachycardiaDiuresis; Aminophylline; Apnea; Prematurity

• Registration Number: TCTR20150114001
• Lead Sponsor: Phramongkutklao College of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2013-09-15
• Study Start: 2015-01-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Infants with gestational age less than 35 weeks and birth weight less than 2,000 grams; required aminophylline for treatment of apnea of prematurity or for prophylaxis before endotracheal extubation; and age at enrollment less than one week.

Exclusion Criteria

Infants who have other identified causes of apnea, congenital anomalies of cardiorespiratory or genitourinary systems or parental refusal to participate in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of achieving theophylline therapeutic level 2-3 hours after loading dose Percent

Secondary Outcome Measures

Name	Time	Method
Theophylline level 2-3 hours after loading dose Theophylline level (microgram per milliliter),Rate of apnea wtihin 24 hours after loading Percent