Health Condition 1: P229- Respiratory distress of newborn, unspecified
Conditions
Interventions
Intervention1: RAM cannula: In the experimental group, RAM cannula will be used a nasal interface in a stand-alone Bubble CPAP device (Bubble CPAP system with F & P nasal interfaceâ??BC 163, Fisher an
Sponsors
Dr Anuj Bhatti
Eligibility
Inclusion criteria
Inclusion criteria: 1) Inborn babies with gestational age between 28weeks to 34weeks and birth weight more than or equal to 1000 g. 2) The presence of respiratory distress (presence of at least two out of three signs: tachypnoea > 60 per minute, intercostal retractions and expiratory grunt) within 6h of life requiring nasal CPAP.
Exclusion criteria
Exclusion criteria: 1) Intubation soon after birth 2) APGAR score 3) Life threatening malformations such as congenital diaphragmatic hernia, trachea- oesophageal fistula, and malformations that would prevent establishment of CPAP due to the anatomical defect such as Pierre- Robinson syndrome and choanal atresia. 4) Conditions where intubation and mechanical ventilation are directly indicated such as apnea and hypotensive shock.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Failure of CPAP within first 72 hrs of lifeTimepoint: first 72 hrs of life | — |
Secondary
| Measure | Time frame |
|---|---|
| Bronchopulmonary dysplasiaTimepoint: by 36 weeks post menstrual age;CPAP failureTimepoint: 7 days;Culture proven sepsisTimepoint: during the hospitalization;deathTimepoint: during hospital stay;Feeding intoleranceTimepoint: any time during hospitalization;Intraventricular hemorrhage (greater than grade 1)Timepoint: during hospitalization;Maximum CPAP pressure (cm H20)Timepoint: 72 hours;Nasal injury scoreTimepoint: 0-7;Necrotizing enterocolitisTimepoint: Stage 2 and 3 during hospitilization;Need for intubation and mechanical ventilationTimepoint: 72 hours of life;PneumothoraxTimepoint: during hospitalization;Pulmonary hemorrhageTimepoint: any time during hospitalization;Remained on CPAP by 7 days of ageTimepoint: 7 days;Remained on CPAP by 72 h of ageTimepoint: 72 hours;Surfactant (post randomization)Timepoint: hours;Suspected sepsisTimepoint: during hospitalization;Total duration of CPAP in hoursTimepoint: hours | — |
Countries
India
Contacts
Public ContactDr Anuj Bhatti
Government Medical College, Jammu
Outcome results
None listed