Health Condition 1: null- Apnea of Prematurity
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: All babies with birth gestation between 26 â?? 32 weeks, on caffeine therapy. Indications for caffeine therapy: 1)As treatment for apnea of prematurity. 2)Prophylactic caffeine therapy in extremely low birth weight infants (birth weight below 1000 g) to avoid intubation and mechanical ventilation, or to enhance extubation. 3)Periextubation caffeine for infants less than 32 weeks and those intubated for RDS.
Exclusion criteria
Exclusion criteria: â?¿Major congenital anomalies â?¿Grade 111 or 1V Intraventricular Hemorrhage (IVH). â?¿On drugs that can cause central nervous system depression â?? morphine, midazolam, antiepileptic drugs (AED)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of babies having clinically significant apnea from randomization till transfer to room in each of the two groups.Timepoint: till rooming in. | — |
Secondary
| Measure | Time frame |
|---|---|
| Abnormal USG cranium at 36-40 weeks Timepoint: 36-40 weeks;All cause mortality during initial hospitalizationTimepoint: during hospital stay;EUGR (extrauterine growth retardation, Z from birth weight) on gender specific Fentons chartTimepoint: at discharge;Gestation specific day of recurrence of apnea from the day caffeine is stopped. Timepoint: till rooming in.;NEC/feed intolerance / tachycardia requiring decrease in caffeine doseTimepoint: till rooming in;Neurological Outcome at discharge assessed by Hammersmith examinationTimepoint: at discharge;Oxygen dependency at postnatal day 28Timepoint: 28 days postnatal age;Proportion of babies requiring interventions for apnea of prematurity , after excluding those with apnea secondary to new sepsis, primary pulmonary pathology (pneumthorax, collapse, pulmonary hemorrhage, pneumonia), anemia, hyponatremia, preterm brain injury (USG cranium / MRI â?? PVL stage 2 or more), GERD requiring therapy, upper airway problems requiring intervention, inborn errors of metabolismTimepoint: till rooming in;Recurrence risk of apnea in subgroup of babies with minimal vs moderate to severe respiratory illness after birthTimepoint: till rooming in.;ROP requiring laser treatment Timepoint: till requiring treatment | — |
Countries
India
Contacts
Kerala Institute of Medical Science