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

NCT ID: NCT03620448

Last Updated: 2018-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-15
• Study Completion Date: 2017-05-15

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.

Conditions

Respiratory Distress Syndrome in Premature Infant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

bCPAP Arm

Intervention Type: DEVICE

bCPAP (Rice 360◦c low cost bCPAP device)

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.

Group Type: OTHER

Oxygen Arm

Intervention Type: OTHER

Oxygen therapy from oxygen cylinders

Interventions

bCPAP Arm

bCPAP (Rice 360◦c low cost bCPAP device)

Intervention Type: DEVICE

Oxygen Arm

Oxygen therapy from oxygen cylinders

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 28 Weeks
• Maximum Eligible Age: 37 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kilimanjaro Christian Medical Centre, Tanzania

OTHER

Sponsor Role: lead

Responsible Party

Dr. Annette M Baine

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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. doi: 10.1371/journal.pone.0086327. eCollection 2014.

Reference Type: RESULT

PMID: 24489715 (View on PubMed)

Other Identifiers

CPAP1

Identifier Type: -

Identifier Source: org_study_id