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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
TCTR
Registry ID
TCTR20150114001
Enrollment
Unknown
Registered
2015-01-14
Start date
2012-08-08
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apnea Tachycardia Diuresis Aminophylline Apnea Prematurity

Interventions

(low loading&#45
high maintenance regimen) received an intravenous loading dose of aminophylline at 5 mg/kg and then maintenance doses at 2 mg/kg every 8 hours&#44
beginning at 8 hours after the loading dose. ,(high loading &#45
low maintenance regimen) received an intravenous loading dose of aminophylline at 8 mg/kg and then maintenance doses at 2 mg/kg every 12 hours&#44
beginning at 12 hours after the loading dose.
Active Comparator Drug,Active Comparator Drug
low loading&#45
high maintenance,high loading &#45
low maintenance regimen

Sponsors

Phramongkutklao College of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
0 Years to 1 Weeks

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Rate of achieving theophylline therapeutic level 2-3 hours after loading dose Percent

Secondary

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

Countries

Thailand

Contacts

Public ContactSangkae Chamnanvanakij

Phramongkutklao

chamnanvanakij@gmail.com66850712700

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026