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

NCT03620448 | Completed FDA Device

• 1 other identifier: CPAP1
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Respiratory Distress Syndrome in Premature Infant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Treatment duration

  6 months

• Duration of hospital stay

  6 months

• Treatment complications

  6 months

Study Arms (2)

bCPAP Arm.

EXPERIMENTAL

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

Oxygen Arm

OTHER

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

Interventions

bCPAP Arm DEVICE

bCPAP (Rice 360◦c low cost bCPAP device)

bCPAP Arm.

Oxygen Arm OTHER

Oxygen therapy from oxygen cylinders

Oxygen Arm

Eligibility Criteria

• Age: 28 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Kilimanjaro Christian Medical Centre, Tanzania: lead

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

  PMID: 24489715 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 2, 2018
• First Posted: August 8, 2018
• Study Start: December 15, 2016
• Primary Completion: May 15, 2017
• Study Completion: May 15, 2017
• Last Updated: August 8, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data will be made available 12 months after study completion.
• Access Criteria: Persons requesting data will be asked to sign a data transfer agreement as well as provide evidence of ethical clearance.