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Blood aminophylline levels in infants with apnea of prematurity : comparing between pharmacokinetics dosing equation and standard dosage

Blood aminophylline levels in infants with apnea of prematurity : comparing between pharmacokinetics dosing equation and standard dosage ; A pilot study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
TCTR
Registry ID
TCTR20151206001
Enrollment
30
Registered
2015-12-06
Start date
2015-08-30
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 of prematurity apnea of prematurity aminophylline

Interventions

Aminophylline dose by using standard dose,Aminophylline dose calculated by using pharmacokinetics dosing equation
Experimental Other,Experimental Other
standard aminophylline dosage,pharmacokinetics dosing equation

Sponsors

Faculty of Medicine Siriraj Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Days to No maximum

Inclusion criteria

Inclusion criteria: 1. Preterm infant less than or equal to 34 weeks gestation 2. Attending physicians plan to start aminophylline indicated by 2.1 apnea of prematurity 2.2 prophylaxis for apnea of prematurity 3. Parents understand Thai language 4. Informed consent obtained

Exclusion criteria

Exclusion criteria: 1. Infants with congenital neurological anomalies or chromosomal abnormality 2. Infants whom apnea is due to other causes, e.g. sepsis 3. infants who are receiving drugs which affect aminophylline level:- phenobarbital, phenytoin, erythromycin and propranolol 4. Infants who received aminophylline within 7 days prior to the study 5. infants with renal insufficiency diagnosed by 5.1 urine output less than 1 ml/kg/hr within 12 hours prior to the study 5.2 creatinine level more than or equal to 1.6 mg/dL for infants less than or equal to 27 weeks gestation 5.3 creatinine level more than or equal to 1.1 mg/dL for infants 28-29 weeks gestation 5.4 creatinine level more than or equal to 1 mg/dL for infants 30-32 weeks gestation 6. Infants who have total bilirubin > 2 mg/dL or SGOT > 140 IU/L or SGPT > 50 IU/L

Design outcomes

Primary

MeasureTime frame
aminophylline level before the 8th maintenance dose of aminophylline blood aminophylline level within therapeutic range

Secondary

MeasureTime frame
side effect of aminophylline throughout the study number of side effects of amniphylline

Countries

Thailand

Contacts

Public ContactSopapan Ngerncham

Faculty of Medicine Siriraj Hospital, Mahidol University

sopapan.nge@mahidol.ac.th6624195713

Outcome results

None listed

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