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

Respiratory Distress Syndrome in Premature Infant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03620448
• Other study ID #: CPAP1
• Status: Completed
• Phase: N/A
• Start date: December 15, 2016
• Est. completion date: May 15, 2017

Study information

• Verified date: August 2018
• Source: Kilimanjaro Christian Medical Centre, Tanzania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: May 15, 2017
• Est. primary completion date: May 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 28 Weeks to 37 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Distress Syndrome in Premature Infant
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Device:
• bCPAP Arm
bCPAP (Rice 360?c low cost bCPAP device)

Other:
• Oxygen Arm
Oxygen therapy from oxygen cylinders

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kilimanjaro Christian Medical Centre, Tanzania

References & Publications (1)

Kawaza K, Machen HE, Brown J, Mwanza Z, Iniguez S, Gest A, Smith EO, Oden M, Richards-Kortum RR, Molyneux E. Efficacy of a low-cost bubble CPAP system in treatment of respiratory distress in a neonatal ward in Malawi. PLoS One. 2014 Jan 29;9(1):e86327. do — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Duration of hospital stay	Time from admission into the neonatal ward to discharge (dead or alive).	6 months
Secondary	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