Immediate Treatment Outcomes of b-CPAP vs Oxygen Therapy in Preterm Babies Presenting With RDS at KCMC

Study Overview
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Brief Summary
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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
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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.

Official Title
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Immediate Treatment Outcomes of Bubble-cpap Versus Oxygen Therapy in Preterm Babies Presenting With Respiratory Distress Syndrome at Kilimanjaro Christian Medical Center

Conditions
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Respiratory Distress Syndrome in Premature Infant

Intervention / Treatment
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* Device: bCPAP Arm
* Other: Oxygen Arm


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 28 Weeks
Maximum Age: 37 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bCPAP Arm.<br>Babies randomized to receive bCPAP were started (by principle investigator assisted by a clinician) on bCPAP (Rice 360◦c low cost bCPAP device) consisting of 3 components: (i) An oxygen concentrator with a gas flow fate of 3-4L/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 6cm in water to generate an end expiratory pressure as seen in appendix 7. adopted from suppliers of the pumani bCPAP machine in Kenya. | Device: bCPAP Arm<br>* bCPAP (Rice 360◦c low cost bCPAP device)<br>|
| Other: Oxygen Arm<br>Preterms on the control arm and those whose parents didn't consent received the standard treatment for RDS i.e pure oxygen via nasal prongs from the oxygen cylinders. | Other: Oxygen Arm<br>* Oxygen therapy from oxygen cylinders<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparing the number of babies that survived with bCPAP treatment versus Oxygen therapy | The proportion of babies discharged alive in the bCPAP arm versus the oxygen therapy arm. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment duration | The time spent on the allocated treatment arm till RDS symptoms (tachypnea (>60breaths/min), intercostal and subcostal recessions, nasal flaring, grunting and cyanosis) resolve. | 6 months | 
| Duration of hospital stay | Time from admission into the neonatal ward to discharge (dead or alive). | 6 months | 
| Treatment complications | 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. | 6 months |