Respiratory Distress Syndrome in Premature Infant
Conditions
Brief summary
Bubble - Continuous positive airway pressure (CPAP) has been reported to be effective, cheaper, simpler and more accessible compared to mechanical ventilator and surfactant treatment for preterms with respiratory distress syndrome in the neighbouring countries. This study aims to implement and determine the effectiveness of bCPAP and its immediate outcomes compared to oxygen therapy in preterm babies presenting with respiratory distress syndrome (RDS).
Detailed description
Effective treatment of preterm babies with RDS requires exogenous surfactant and/or mechanical ventilation but these are of limited availability in developing countries. bCPAP is generated by exhalation against a constant opening pressure that produces positive end-expiratory pressure. This in-turn helps in maintaining lung volume at the end of expiration, preventing atelectasis, improving oxygenation, reducing respiratory fatigue and eventually preventing respiratory failure. bCPAP (Rice 360◦c low cost bCPAP device) consisting of 3 components: : (i)An air compressor connected to an oxygen concentrator with a gas flow fate of 3-4 L/min; (ii) A nasal interface (short nasal prongs) connecting the baby's airway to a two limb circuit i.e the inspiratory limb connected to the bCPAP machine and the expiratory limb connected to the water bottle and; (iii) An expiratory limb with the distal end submerged 6 cm in water to generate an end expiratory pressure At the neonatal unit at Kilimanjaro Christian Medical Center (KCMC), the standard of care for Preterm babies with RDS is receiving oxygen therapy via nasal prongs from oxygen cylinders.
Interventions
DEVICEbCPAP Arm
bCPAP (Rice 360◦c low cost bCPAP device)
OTHEROxygen Arm
Oxygen therapy from oxygen cylinders
Sponsors
Kilimanjaro Christian Medical Centre, Tanzania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
28 Weeks to 37 Weeks
Healthy volunteers
No
Inclusion criteria
* All preterm babies (\< 37 weeks of gestation determined using Finnstorm score) presenting with signs of RDS (tachypnea of \>60breaths /min, intercostal and subcostal recessions, nasal flaring, grunting and cyanosis)
Exclusion criteria
* Preterm babies with birthweight less than 1kg (bCPAP machine can only be used in babies with body weight of 1-10kg) * Congenital malformations (cleft palate and lip, tracheal esophageal fistula and diaphragmatic hernia) * Mothers who refused to consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparing the number of babies that survived with bCPAP treatment versus Oxygen therapy | 6 months | The proportion of babies discharged alive in the bCPAP arm versus the oxygen therapy arm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment duration | 6 months | The time spent on the allocated treatment arm till RDS symptoms (tachypnea (\>60breaths/min), intercostal and subcostal recessions, nasal flaring, grunting and cyanosis) resolve. |
| Duration of hospital stay | 6 months | Time from admission into the neonatal ward to discharge (dead or alive). |
| Treatment complications | 6 months | Whilst the subject is receiving treatment, the following complications will be observed and recorded; like pneumothorax, nasal bleeding, injury to the skin, nose or eye, aspiration pneumonia, vomiting and any other complication considered related to the treatment as per the principal investigator's clinical judgement. |
Outcome results
None listed