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

Kilimanjaro Christian Medical Centre, Tanzania

Status: Completed

Conditions: Respiratory Distress Syndrome in Premature Infant

Treatments: Device: bCPAP Arm; Other: Oxygen Arm

Study type: Interventional

Funder types: Other

Identifiers

NCT03620448

CPAP1

Details and patient eligibility

About

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).

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 28 to 37 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

bCPAP Arm.

Experimental group

Description:

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.

Treatment:

Device: bCPAP Arm

Oxygen Arm

Other group

Description:

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.

Treatment:

Other: Oxygen Arm