Health Condition 1: null- Neonates with Apnea of Prematurity
Conditions
Interventions
Intervention1: Aminophylline and Caffeine: Both are Methylxanthine group of agents which are administered to the neonates as Prophylaxis, treatment to cure Apnea of Prematurity and to facilitate extub
Sponsors
Kasturba Medical College
Dr Leslie Edward S Lewis
Eligibility
Inclusion 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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic and Pharmacodynaminc model - obtained by computing clearance and Volume of distribution with respect to different covariates like growth category, type of nutrituion, fluid intakes, weight, gestational age and post natal age. Pharmacokinetic profiles are evaluated by assessing the drug levels. Pharmacodynamic effects are assessed by observing frequency of apneic episodes, Mean apneic rate, desaturations, bradycardia.Timepoint: Pharmacokinetic - every 7th month plasma samples are evaluated by LCMS technique and final model development part will be done at 30th month. Pharmacodynamic - first two weeks of Methylxanthine administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in apneic episodes, facilitation of extubation, duration of ventilatory support and need for ventilation, time of commencement and time to stop the therapy, Hospital stay, NICU stay, Heart rate, Adverse reaction, complications if any.Timepoint: first 3 days of methylxanthine initiation, 4 to 7th day and 8th to 14 day of therapy. Hospital stay will be assessed to check for length of hospitalization. | — |
Countries
India
Contacts
Public ContactShivakumar
Kasturba Medical College
Outcome results
None listed