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

Not Applicable

Completed

• Conditions: Respiratory Distress Syndrome in Premature Infant
• Interventions: Device: bCPAP Arm; Other: Oxygen Arm

• Registration Number: NCT03620448
• Lead Sponsor: Kilimanjaro Christian Medical Centre, Tanzania

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.

Study Timeline

• Study Start: 2016-12-15
• Primary Completion: 2017-05-15
• Study Completion: 2017-05-15
• Study First Submitted: 2018-07-02
• Status Verified: 2018-08
• Study First Submitted QC: 2018-08-03
• Last Update Submitted: 2018-08-03
• Study First Posted: 2018-08-08
• Last Update Posted: 2018-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bCPAP Arm.	bCPAP Arm	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.
Oxygen Arm	Oxygen Arm	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Duration of hospital stay	6 months	Time from admission into the neonatal ward to discharge (dead or alive).
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.