Health Condition 1: null- Gastroesophageal reflux associated apnea of preterm neonates
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria (i) Intramural live births. (ii) Gestational age less than 37 weeks. (iii) Babies on enteral feeding (partial/complete) with human milk with recurrent apnea clinically suspected to be due to gastroesophageal reflux. (iv) Parents or caregivers or their legally acceptable/ authorised representatives consenting to take part in the study.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: (i) Extramural live births (ii) Neonates not on enteral feeds due to any reason (iii) Neonates on invasive mechanical ventilation (iv) Neonates with major congenital anomalies (v) Neonates with apnea diagnosed to be due to conditions other than gastroesophageal reflux. Thus, preterm neonates with apnea diagnosed to be due to sepsis, metabolic disturbances, electrolyte imbalances, patent ductus arteriosus, intracranial hemorrhage etc will be excluded. (vi) Parents or caregivers or their legally acceptable/ authorised representatives not consenting to take part in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of episodes of apneaTimepoint: 48 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of gastrointestinal disturbancesTimepoint: 72 hours;Incidence of necrotizing enterocolitisTimepoint: 72 hours;All cause mortalityTimepoint: 72 hours | — |
Countries
India
Contacts
Medical College Kolkata